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Trichotillomania is characterized by recurrent pulling out of one's hair, leading to significant hair loss and accompanied by clinically significant distress and/or functional impairment. The current study used data from a randomized controlled trial comparing the effectiveness of acceptance-enhanced behavior therapy (AEBT) to psychoeducation plus supportive therapy (PST; active control) for trichotillomania in an adult sample. The objectives were to examine the moderating and mediating influence of trichotillomania-specific psychological flexibility in treatment for trichotillomania. Participants with lower baseline flexibility performed better in AEBT than PST in terms of greater symptom reduction and quality of life. Lower baseline flexibility also predicted higher likelihood of disorder recovery in AEBT relative to PST. In addition, relative to PST, symptom reduction in AEBT was mediated by psychological flexibility, controlling for anxiety and depression. These findings suggest that psychological flexibility is a relevant process of change in the treatment of trichotillomania. Clinical implications and directions for future research are discussed.

This study examined client ratings of 26 facilitators and barriers to anxiety improvement approximately 6 years after randomization to treatment for anxiety.319 youth (average 17.12 years old; 82.1% Caucasian; 58.6% female) participated in the longitudinal follow-up study to child and adolescent anxiety multimodal study (CAMS), a randomized controlled trial of medication, cognitive-behavioral therapy (CBT), combination, and placebo.Correcting for multiple comparisons, CBT components (i.e., problem solving, changing unhelpful thoughts, relaxation skills) were rated significantly more helpful among youth without, versus with, an anxiety disorder at follow-up. Barriers that differentiated youth with and without an anxiety disorder included being bullied and difficulty applying therapy content to new situations. Comparisons between youth with different anxiety disorder trajectories (e.g., stable remission, relapsed, or chronically ill) also revealed several differences.Findings suggest that client-rated facilitators and barriers covary with anxiety disorder recovery and may serve as useful tools when evaluating long-term treatment efficacy.

Cognitive behavioral therapy (CBT) is the first choice of treatment of obsessive–compulsive disorder (OCD) in children and adolescents. However, there is often a lack of access to appropriate treatment close to the home of the patients. An internet-based CBT via videoconferencing could facilitate access to state-of-the-art treatment even in remote areas. The aim of this study was to investigate feasibility and acceptability of this telemedical approach. A total of nine children received 14 sessions of CBT. The first session took place face-to-face, the remaining 13 sessions via videoconference. OCD symptoms were recorded with a smartphone app and therapy materials were made accessible in a data cloud. We assessed diagnostic data before and after treatment and obtained measures to feasibility, treatment satisfaction and acceptability. Outcomes showed high acceptance and satisfaction on the part of patients with online treatment (89%) and that face-to-face therapy was not preferred over an internet-based approach (67%). The majority of patients and their parents classified the quality of treatment as high. They emphasized the usefulness of exposures with response prevention (E/RP) in triggering situations at home. The app itself was rated as easy to operate and useful. In addition to feasibility, a significant decrease in obsessive–compulsive symptoms was also achieved. Internet-based CBT for pediatric OCD is feasible and well received by the patients and their parents. Furthermore, obsessive–compulsive symptomatology decreased in all patients. The results of this study are encouraging and suggest the significance of further research regarding this technology-supported approach, with a specific focus on efficacy.Trial registration number: Clinical trials AZ53-5400.1-004/44.

Objectives: To describe the study design and clinical characteristics of patients in the Sertraline Pediatric RegIstry for The Evaluation of Safety (SPRITES). Methods: SPRITES is an open-label post...

Attention-deficit/hyperactivity disorder (ADHD) symptoms affect 40-60% of autistic children and have been linked to differences in adaptive behavior. It is unclear whether adaptive behavior in autistic youth is directly impacted by co-occurring ADHD symptoms or by another associated feature of both autism and ADHD, such as increased irritability. The current study examined relationships between irritability, ADHD symptoms, and adaptive behavior in 3- to 7-year-old autistic children. Results suggest that, after adjusting for co-occurring ADHD symptoms, higher levels of irritability are associated with differences in social adaptive behavior specifically. Understanding relationships between irritability, ADHD, and adaptive behavior in autistic children is critical because measures of adaptive behavior, such as the Vineland Scales of Adaptive Functioning, are often used as a proxy for global functioning, as well as for developing intervention plans and measuring outcomes as primary endpoints in clinical trials.

Background: There has been increased research interest into the concept of treatment integrity within psychotherapy research. The Competence and Adherence Scale for Cognitive Behavioural Therapy (CAS-CBT) was developed to measure therapists’ competence and adherence in cognitive behavioural therapy (CBT), when delivered to children and youth with anxiety disorders. Aims: The aim of this study was to evaluate the psychometric properties of the CAS-CBT in a naturalistic treatment setting. Method: Ratings of 212 randomly selected sessions from a clinical effectiveness trial for children with anxiety disorders (n = 165, mean age = 10.46 years, SD = 1.49) were analysed to assess the psychometric properties of CAS-CBT. Therapy format included both individual sessions and group sessions. Results: Internal consistency for the CAS-CBT was excellent (Cronbach’s alpha = .88). Factor analysis suggested a two-factor solution for the total sample, where the first factor was related to CBT structure and session goals, and the second factor was associated with process and relational skills. The individual CBT treatment condition (ICBT) and group CBT treatment condition (GCBT) showed the same factor solution. Conclusion: The CAS-CBT is a feasible and reliable measure for assessing competence and adherence to CBT in the treatment of anxious children. Future research is needed to further assess the generalizability of this scale, its psychometric properties in different treatment populations and with other treatment approaches, and ideally with larger sample sizes.

The present study aimed to investigate the long-term quality of life (QoL) in a large sample of pediatric obsessive–compulsive disorder (OCD) patients. The study included 220 pediatric OCD patients from the Nordic Long-term OCD Treatment Study (NordLOTS) who were evaluated at seven time points before, during, and after stepped-care treatment over a 3-year follow-up period. Data from three symptom severity trajectory classes formed the basis of the QoL evaluation: acute (n = 127, N = 147), slow (n = 46, N = 63), and limited responders (n = 47, N = 59). Patients’ QoL was assessed using parent and child ratings of the revised Questionnaire for Measuring Health-related Quality of Life in Children and Adolescents (KINDL-R). QoL was analyzed by trajectory class using a random mixed effects model. The association between pre-treatment factors and long-term QoL was investigated across classes in a multivariate model. Three years after treatment, the acute responder class had reached QoL levels from a general population, whereas the limited responder class had not. The slow responder class reached norm levels for the child-rated QoL only. Higher levels of co-occurring externalizing symptoms before treatment were associated with lower parent-rated QoL during follow-up, while adolescence and higher levels of co-occurring internalizing symptoms were associated with lower child-rated QoL during follow-up. For some patients, residual OCD symptoms in the years after treatment, even at levels below assumed clinical significance, are associated with compromised QoL. Co-occurring symptoms could be part of the explanation. Assessing QoL after OCD treatment, beyond the clinician-rated symptom severity, could detect patients in need of further treatment and/or assessment. Trial registry: Nordic Long-term Obsessive–Compulsive Disorder (OCD) Treatment Study; www.controlled-trials.com ; ISRCTN66385119.

Objective This article examined associations between change in youth and family characteristics during youth anxiety treatment and long-term anxiety severity and overall functioning. Method Participants (N = 488; age 7-17 years; 45% male; 82% white) were randomized to 12 weeks of cognitive behavioral therapy (Coping Cat), medication (sertraline), their combination, or pill placebo in the Child/Adolescent Anxiety Multimodal Study (CAMS). A subset participated in the naturalistic follow-up Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS; n = 319; 3.70-11.83 years post-treatment). The current secondary analyses examined how change in anxiety severity (Child Global Impression-Severity), overall functioning (Children's Global Assessment Scale), caregiver psychopathology (Brief Symptom Inventory), caregiver strain (Family Burden Assessment Scale), and family dysfunction (Brief Family Assessment Measure) during CAMS was associated with anxiety severity and overall functioning years later (M = 7.72 years). CAMS procedures were registered on clinialtrials.gov. Results Improvements in factors related to functioning (i.e., overall functioning, family dysfunction, caregiver strain) were associated with improvements in anxiety severity in CAMELS (|βys| ≥ .04, ps ≤ .04). Improvements in factors related to psychopathology (i.e., anxiety severity, caregiver psychopathology) were associated with improvements in overall functioning in CAMELS (|βys| ≥ .23, ps ≤ .04). It was changes in each of the variables examined (rather than baseline values) that predicted anxiety severity and overall functioning. Conclusions Both youth and family factors play a significant role in long-term treatment outcomes. Therapists would be wise to monitor how these factors change throughout treatment. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Long-term follow-up studies of anxiety treatment have found that greater exposure to negative life events (NLEs) predicts poorer anxiety outcomes, but none have examined whether specific types of NLEs are differentially associated with child outcomes. This study examined the frequency of NLEs and whether specific types of NLEs were associated with increased risk of having an anxiety disorder 6.5 years post randomization. Participants were 319 adolescents and adults, ages 11 to 26 (M = 17), enrolled in Child/Adolescent Anxiety Multimodal Extended Long-term Study. At their first follow-up visit, participants completed a diagnostic interview and a 40-item Life Events Scale that reflected whether specific events occurred since their last post treatment assessment. Life events were categorized into domains (i.e., family, academic, health, and social) via researcher consensus. Participants reported having experienced an average of four NLEs. Participants with an anxiety disorder at follow-up were significantly more likely to have failed a grade in school (OR = 5.9) and experienced a negative change in acceptance by peers (OR = 4.9; ps

Although in-session factors of CBT for youth anxiety (e.g., youth involvement; therapist behaviors) have demonstrated significant associations with treatment outcomes, no study has examined the role of concurrent selective-serotonin reuptake inhibitors (SSRI) on in-session behavior affecting youth outcomes. The combination of SSRI and CBT have demonstrated robust outcomes over either treatment alone. Research has also neglected to examine in-session behavior based on treatment phase (i.e., psychoeducation, exposure) and the association between in-session factors and treatment outcome. Youth (N = 190) were participants in the Children/Adolescent Anxiety Multimodal Study (Walkup et al. New England Journal of Medicine, 359, 2753-2766, 2008) who completed CBT; of these, n = 94 received concurrent sertraline. Tapes of psychoeducation/skill-building (first half) and exposure sessions (second half) were rated by reliable coders for positive youth involvement (e.g., participation, understanding), negative youth involvement (e.g., safety-behaviors, negative affect), and therapist behaviors. Youth and therapist in-session behaviors were examined as predictors of the trajectory of anxiety outcomes using multilevel modeling. Medication (sertraline) was examined as a moderator. Results indicated that positive and negative youth involvement in CBT was significantly associated with outcomes. Positive youth involvement during psychoeducation and exposure sessions predicted better outcomes, and negative youth involvement during psychoeducation sessions predicted less favorable outcomes. Sertraline did not moderate these findings. Therapist behaviors were not significantly associated with outcomes, likely due to limited variability and low frequency of observed behaviors. Youth in-sessions behaviors are associated with treatment outcomes in anxiety treatment. However, medication does not appear to have a differential impact on youth in-session behaviors.

The current study explored whether patient characteristics predicted patterns of antidepressant use (i.e., never used, single episode of use, or two or more episodes) in a naturalistic follow-up. Participants in the child/adolescent multimodal (CAMS) extended long-term study. (n = 318) indicated medication use over the course of eight follow-up visits, 3-12 years after receiving treatment in CAMS. 40.6% of participants reported never using an antidepressant during follow-up, 41.4% reported a single episode of antidepressant use, and 18.0% reported multiple episodes of antidepressant use. Greater baseline anxiety severity marginally predicted a single episode of antidepressant use; baseline depression severity predicted multiple episodes of use. Reasons for discontinuing antidepressants included perceived ineffectiveness (31.8%), side effects (25.5%), and improvement in symptoms (18.5%). Exploratory analyses examined predictors of medication use. Findings suggest that antidepressant use is common among anxious youth, as is discontinuation of antidepressant use. Clinical implications and future directions are discussed.

Introduction Obsessive–compulsive disorder (OCD) is a disabling mental health disorder affecting 1–3% of children and adolescents. Cognitive behavioral therapy (CBT) is recommended as the first-line treatment, but is limited by accessibility, availability, and, in some cases, response to treatment. Enhancement with Internet technologies may mitigate these challenges. Methods We developed an enhanced CBT (eCBT) treatment package for children and adolescents with OCD to improve treatment effect as well as user-friendliness. This study aims to explore the feasibility, acceptability, and preliminary effectiveness of the eCBT intervention. The eCBT protocol consists of 10 face-to-face and 12 webcam sessions delivered in 14 weeks. CBT is enhanced by a smartphone application (app) for children and parents to support and monitor treatment, psychoeducative videos, and therapist-guided webcam exposure exercises conducted at home. Assessments were performed at baseline, post-treatment, and at 3- and 6-month follow-up. Primary measures of outcomes were the the Client Satisfaction Questionnaire-8 (CSQ-8) (acceptability), treatment drop-out (feasibility) and the Children’s Yale-Brown Obsessive–Compulsive Scale (CY-BOCS) (preliminary effectiveness). Results This paper describes 25 patients with OCD (aged 8–17 years) treated with eCBT. Results indicated that children and parents were satisfied with eCBT, with CSQ-8 mean scores of 27.58 (SD 0.67) and 29.5 (SD 3.74), respectively (range 8–32). No patients dropped out from treatment. We found a mean of 63.8% symptom reduction on the CY-BOCS from baseline to post-treatment. CY-BOCS scores further decreased during 3-month and 6-month follow-up. Conclusion In this explorative study, eCBT for pediatric OCD was a feasible, acceptable intervention demonstrating positive treatment outcomes.

Given the limited treatment options for trichotillomania (TTM), or Hair Pulling Disorder, this large randomized clinical trial evaluated the efficacy of acceptance-enhanced behavior therapy for TTM (AEBT-TTM) in reducing TTM severity relative to psychoeducation and supportive therapy (PST). Eighty-five adults (78 women) with TTM received 10 sessions (over 12 weeks) of either AEBT-TTM or PST. Independent evaluators masked to treatment assignment assessed participants at baseline (week 0), midpoint (week 6), and endpoint (week 12). Consistent with a priori hypotheses, 64% of the adults treated with AEBT-TTM were classified as clinical responders at post-treatment relative to 38% treated with PST. Clinical responders were identified by a score of 1 or 2 on the Clinical Global Impressions-Improvement (CGI-I) scale. Relative to the PST group, the AEBT-TTM group demonstrated significantly greater pre-to post-treatment reductions on the self-report Massachusetts General Hospital-Hairpulling Scale (MGH-HS) and the evaluator-rated National Institute of Mental Health Trichotillomania Severity Scale (NIMH-TSS). There were no significant post-treatment group differences on the Clinical Global Impressions-Severity (CGI-S) scale, or rate of TTM diagnoses. Results suggest AEBT-TTM provides greater treatment benefit than PST. Future research should continue to investigate AEBT-TTM along with mediators and moderators of its efficacy.

Background: Pediatric anxiety disorders are highly prevalent and associated with significant functional disabilities and lifelong morbidity. Cognitive-behavioral therapy (CBT), sertraline, and their combination are effective treatments, but little is known about how these treatments exert their effects.Methods: Using network intervention analysis (NIA), we analyzed data from the largest randomized controlled treatment trial of pediatric anxiety disorders (Child/Adolescent Anxiety Multimodal Study, NCT00052078, clinicaltrials.gov/ct2/show/NCT00052078) and outlined the causal symptom domain-specific effects of CBT, sertraline, and their combination over the course of the 12-week treatment while taking into account both specificity and overlap between symptom dimensions. Results: All active treatments produced positive effects with the most pronounced and consistent effects emerging in relation to psychological distress, family interference, and avoidance. Psychological distress was consistently the most and physical symptoms the least influential symptom domain in the disorder network.Conclusions: All active treatments showed beneficial effects when compared to placebo and NIA identified that these effects were exerted similarly across treatments and primarily through a reduction of psychological distress, family interference, and avoidance. CBT and sertraline may have differential mechanisms of action in relation to psychological distress. Given the lack of causal effects on interference outside family and physical symptoms, interventions tailored to target these domains may aid in the building of more effective treatments. Psychological distress and avoidance should remain key treatment focuses because of their central roles in the disorder network. The findings inform and promote developing more effective interventions. Keywords: CBT/cognitive behavior therapy; anxiety/anxiety disorders; pharmacotherapy; clinical trials; child/adolescent. (Less)

Background Youth anxiety interventions have potential to reduce risk for depression and suicidality. Methods This naturalistic follow-up of the multi-site, comparative treatment trial, inking and behavior, and depressive symptoms 3-11 years (mean 6.25 years) following 12-week evidence-based youth anxiety treatment. Participants (N = 319; 10-26 years, mean 17 years) completed semiannual questionnaires and annual diagnostic interviews for 4 years. Results One-fifth (20.4%) of the sample met DSM-IV criteria for a mood disorder, 32.1% endorsed suicidal ideation, and 8.2% reported suicidal behavior. Latent class growth analysis yielded two linear trajectories of depressive symptoms, and 85% of the sample demonstrated a persistent low-symptom course over seven assessments. Child/Adolescent Anxiety Multimodal Study (CAMS) 12-week treatment outcome (positive response, remission) and treatment condition (cognitive behavior therapy [CBT], medication, CBT + medication, pill placebo) were not associated with subsequent mood disorder or suicidal thinking. CAMS remission predicted absence of suicidal behavior, and treatment response and remission predicted low depressive symptom trajectory. Greater baseline self-reported depressive symptoms predicted all long-term mood outcomes, and more negative life events predicted subsequent mood disorder, depressive symptom trajectory, and suicidal ideation. Conclusions Effective early treatment of youth anxiety, including CBT, medication, or CBT + medication, reduces risk for subsequent chronic depressive symptoms and suicidal behavior. Attention to (sub)clinical depressive symptoms and management of negative life events may reduce odds of developing a mood disorder, chronic depressive symptoms, and suicidality. Findings contribute to evidence that early intervention for a primary disorder can serve as secondary prevention.

Expectancies for a favorable treatment outcome have been associated with actual favorable outcomes but have been understudied in youth with anxiety. The current study applied structural equation modeling in a sample of anxious youth (N = 488; 7–17 years, M = 10.69, SD = 2.80) to examine whether a multi-informant latent expectancies factor, indicated by youth, parent, and therapist reports, predicted a latent posttreatment anxiety factor, controlling for a latent pretreatment anxiety factor. Both anxiety latent factors were indicated by youth, parent, and independent evaluator (IE) reports. Analyses also examined whether treatment condition (cognitive behavioral therapy, sertraline, combination, pill placebo) moderated the association between expectancies and outcome, and whether this association differed across development. Findings indicated that informant reports loaded similarly onto the latent factors. Results also demonstrated that treatment expectancies were positively associated with outcomes, and that this relationship held across treatment type and age group. Treatment implications and future research directions are discussed.

Objectives: Psychotherapy is an effective, recommended treatment for pediatric anxiety disorders. Nevertheless, individuals with mental health conditions often do not receive psychotherapy, with variation across provider types. This study sought to examine psychotherapy claims surrounding medication initiation in U.S. children with diagnosed anxiety disorders. Methods: The study cohort included privately insured children (3–17 years) with a diagnosed anxiety disorder initiating a medication to treat anxiety from 2004 to 2014. We examined psychotherapy claims in the 3 months before and 3 months after medication initiation and described children with multiple (2+) psychotherapy claims per 3-month period. Results: Of the 75,024 children initiating a medication for anxiety (median age = 14 years, 58% female), 35% had multiple psychotherapy claims before medication initiation, with variation by age, anxiety disorder, and psychiatric comorbidity and with little change across time. Psychotherapy claims after medication initiation varied by whether the child had prior psychotherapy: 80% in children with prior psychotherapy and 30% in children without prior psychotherapy claims (44% of children diagnosed by a psychiatrist, 21% of children diagnosed by a pediatrician). Conclusion: Many privately insured children do not have claims for psychotherapy before or after pharmacotherapy initiation for anxiety. Findings can inform future research and efforts to ultimately increase appropriate psychotherapy utilization in children with anxiety disorders.

Objective Pediatric anxiety disorders can have a chronic course and are considered gateway disorders to adult psychopathology, but no consistent predictors of long-term outcome have been identified. A single latent symptom dimension that reflects features shared by all mental health disorders, the p factor, is thought to reflect mechanisms that cut across mental disorders. Whether p predicts outcome in youth with psychiatric disorders has not been examined. We tested whether the p factor predicted long-term psychiatric and functional outcomes in a large, naturalistically followed-up cohort of anxiety-disordered youth. Method Children and adolescents enrolled in a randomized controlled treatment trial of pediatric anxiety were followed-up on average 6 years posttreatment and then annually for 4 years. Structural equation modeling was used to estimate p at baseline. Both p and previously established predictors were modeled as predictors of long-term outcome. Results Higher levels of p at baseline were related to more mental health disorders, poorer functioning, and greater impairment across all measures at all follow-up time points. p Predicted outcome above and beyond previously identified predictors, including diagnostic comorbidity at baseline. Post hoc analyses showed that p predicted long-term anxiety outcome, but not acute treatment outcome, suggesting that p may be uniquely associated with long-term outcome. Conclusion Children and adolescents with anxiety disorders who present with a liability toward broad mental health problems may be at a higher risk for poor long-term outcome across mental health and functional domains. Efforts to assess and to address this broad liability may enhance long-term outcome.

Importance Atypical eye gaze is an early-emerging symptom of autism spectrum disorder (ASD) and holds promise for autism screening. Current eye-tracking methods are expensive and require special equipment and calibration. There is a need for scalable, feasible methods for measuring eye gaze. Objective Using computational methods based on computer vision analysis, we evaluated whether an app deployed on an iPhone or iPad that displayed strategically designed brief movies could elicit and quantify differences in eye-gaze patterns of toddlers with ASD vs typical development. Design, Setting, and Participants A prospective study in pediatric primary care clinics was conducted from December 2018 to March 2020, comparing toddlers with and without ASD. Caregivers of 1564 toddlers were invited to participate during a well-child visit. A total of 993 toddlers (63%) completed study measures. Enrollment criteria were aged 16 to 38 months, healthy, English- or Spanish-speaking caregiver, and toddler able to sit and view the app. Participants were screened with the Modified Checklist for Autism in Toddlers–Revised With Follow-up during routine care. Children were referred by their pediatrician for diagnostic evaluation based on results of the checklist or if the caregiver or pediatrician was concerned. Forty toddlers subsequently were diagnosed with ASD. Exposures A mobile app displayed on a smartphone or tablet. Main Outcomes and Measures Computer vision analysis quantified eye-gaze patterns elicited by the app, which were compared between toddlers with ASD vs typical development. Results Mean age of the sample was 21.1 months (range, 17.1-36.9 months), and 50.6% were boys, 59.8% White individuals, 16.5% Black individuals, 23.7% other race, and 16.9% Hispanic/Latino individuals. Distinctive eye-gaze patterns were detected in toddlers with ASD, characterized by reduced gaze to social stimuli and to salient social moments during the movies, and previously unknown deficits in coordination of gaze with speech sounds. The area under the receiver operating characteristic curve discriminating ASD vs non-ASD using multiple gaze features was 0.90 (95% CI, 0.82-0.97). Conclusions and Relevance The app reliably measured both known and new gaze biomarkers that distinguished toddlers with ASD vs typical development. These novel results may have potential for developing scalable autism screening tools, exportable to natural settings, and enabling data sets amenable to machine learning.

Background This study is part of a larger research program focused on developing objective, scalable tools for digital behavioral phenotyping. We evaluated whether a digital app delivered on a smartphone or tablet using computer vision analysis (CVA) can elicit and accurately measure one of the most common early autism symptoms, namely failure to respond to a name call. Methods During a pediatric primary care well-child visit, 910 toddlers, 17-37 months old, were administered an app on an iPhone or iPad consisting of brief movies during which the child's name was called three times by an examiner standing behind them. Thirty-seven toddlers were subsequently diagnosed with autism spectrum disorder (ASD). Name calls and children's behavior were recorded by the camera embedded in the device, and children's head turns were coded by both CVA and a human. Results CVA coding of response to name was found to be comparable to human coding. Based on CVA, children with ASD responded to their name significantly less frequently than children without ASD. CVA also revealed that children with ASD who did orient to their name exhibited a longer latency before turning their head. Combining information about both the frequency and the delay in response to name improved the ability to distinguish toddlers with and without ASD. Conclusions A digital app delivered on an iPhone or iPad in real-world settings using computer vision analysis to quantify behavior can reliably detect a key early autism symptom-failure to respond to name. Moreover, the higher resolution offered by CVA identified a delay in head turn in toddlers with ASD who did respond to their name. Digital phenotyping is a promising methodology for early assessment of ASD symptoms.

BACKGROUND Depression as a disorder in childhood began to be increasingly recognised in the 1970s. Epidemiologic community and clinic-based studies have characterised the prevalence, clinical course, and complications of this illness throughout childhood and adolescence into adulthood. This paper reviews two instruments for assessing depression in prepubertal children - the Dominic Interactive and The Preschool Age Psychiatric Assessment. Both instruments are useful in screening for psychiatric disorders and reliably identifying the presence of depressive symptoms in young children.

This randomized controlled trial compared the Collaborative Assessment and Management of Suicidality (CAMS) and treatment as usual (TAU) for suicidal college students within a feasibility trial. Sixty-two suicidal college students were randomized to CAMS (n = 33) or TAU (n = 29). We hypothesized that those receiving CAMS would show more improvement in suicide-related measures, and effects would be moderated by borderline personality disorder (BPD), prior suicide attempts, and age. Both treatment groups showed improvements in all outcome variables; CAMS had a significantly higher impact on depression and suicidal ideation when measured weekly during care and was more likely than TAU to decrease hopelessness among students with fewer BPD features, no suicide attempt history, and older age. Conversely, TAU did better for students with BPD features and multiple suicide attempts.

Anxiety disorders are prevalent and significantly impact young children and their families. One hypothesized risk factor for anxiety is heightened responses to sensory input. Few studies have explored this hypothesis prospectively. This study had two goals: (1) examine whether sensory over-responsivity is predictive of the development of anxiety in a large prospective sample of children, and (2) identify whether anxiety mediates the relationship between sensory over-responsivity and behavioral challenges. Children's sensory and anxiety symptoms were assessed in a community sample of 917 at 2-5 and again in 191 of these children at 6 years old. Parents also reported on a number of additional behavioral challenges previously found to be associated with both sensory over-responsivity and anxiety separately: irritability, food selectivity, sleep problems, and gastrointestinal problems. Forty three percent of preschool children with sensory over-responsivity also had a concurrent impairing anxiety disorder. Preschool sensory over-responsivity symptoms significantly and positively predicted anxiety symptoms at age six. This relationship was both specific and unidirectional. Finally, school-age anxiety symptoms mediated the relationship between preschool sensory over-responsivity symptoms and both irritability and sleep problems at school-age. These results suggest sensory over-responsivity is a risk factor for anxiety disorders. Furthermore, children who have symptoms of sensory over-responsivity as preschoolers have higher levels of anxiety symptoms at school-age, which in turn is associated with increased levels of school-age behavioral challenges.

Background Anxiety disorders are one of the most common mental illnesses in children and associated with high healthcare utilization. We aimed to estimate 2-year cumulative incidence of mental health-related hospitalizations, treated self-harm, and emergency room (ER) visits in children newly diagnosed with anxiety disorders and, for context, in children without anxiety disorders. Methods We identified commercially insured treatment naive children (3-17 years) with a new office-based anxiety disorder diagnosis (ICD-9-CM) from 2005-2014 in the MarketScan claims database. We followed children for up to 2 years after diagnosis for the first of each event: mental health-related hospitalization, inpatient, treated self-harm, and ER visits (any, anxiety-related, injury-related). Children without anxiety diagnoses were included as comparators, matched on age, sex, date, and region. We estimated cumulative incidence of each event using Kaplan-Meier analysis. Results From 2005-2014, we identified 198,450 children with a new anxiety diagnosis. One-year after anxiety diagnosis, 2.0% of children had a mental health-related hospitalization, 0.08% inpatient, treated self-harm, 1.4% anxiety-related ER visit, and 20% any ER visit; incidence was highest in older children with baseline comorbid depression. One-year cumulative incidence of each event was lower in the comparison cohort without anxiety (e.g., mental health-related hospitalizations = 0.5%, treated self-harm = 0.01%, and ER visits = 13%). Conclusions Given the prevalence of anxiety disorders, 2-year incidence estimates translate to a significant number of children experiencing each event. Our findings offer caregivers, providers, and patients information to better understand the burden of anxiety disorders and can help anticipate healthcare utilization and inform efforts to prevent these serious events.

This study was a phase I, single-center, and open-label trial of a single intravenous infusion of autologous umbilical cord blood in young children with autism spectrum disorder (ASD). Twenty-five children between the ages of 2 and 6 with a confirmed diagnosis of ASD and a qualified banked autologous umbilical cord blood unit were enrolled. Safety results and clinical outcomes measured at 6 and 12 months post-infusion have been previously published. The purpose of the present analysis was to explore whether measures of electroencephalography (EEG) theta, alpha, and beta power showed evidence of change after treatment and whether baseline EEG characteristics were predictive of clinical improvement. The primary endpoint was the parent-reported Vineland adaptive behavior scales-II socialization subscale score, collected at baseline, 6- and 12-month visits. In addition, the expressive one word picture vocabulary test 4 and the clinical global impression-improvement scale were administered. Electrophysiological recordings were taken during viewing of dynamic social and nonsocial stimuli at 6 and 12 months post-treatment. Significant changes in EEG spectral characteristics were found by 12 months post-infusion, which were characterized by increased alpha and beta power and decreased EEG theta power. Furthermore, higher baseline posterior EEG beta power was associated with a greater degree of improvement in social communication symptoms, highlighting the potential for an EEG biomarker to predict variation in outcome. Taken together, the results suggest that EEG measures may be useful endpoints for future ASD clinical trials.

Bioecological models of developmental psychopathology underscore the role of familial experiences of adversity and children's individual-level characteristics in heightening risk for pediatric anxiety through direct, combined, and interactive effects. To date, much of the existing research dedicated to pediatric anxiety disorders has largely been examined in bioecological models of diathesis-stress using community samples. This study extends our understanding of children's differential responsiveness to familial adversity by examining the diathesis-stress interaction of cumulative risk and children's individual-level vulnerabilities (negative affectivity and coping efficacy) within a clinic-referred treatment study for pediatric anxiety disorders. A cumulative risk index assessing exposure to familial adversity (e.g., socioeconomic status [SES], parent psychiatric illness) and self-reported measures of children's negative affectivity and coping efficacy were each measured at the intake of a randomized controlled clinical trial for the treatment of pediatric anxiety disorders (N = 488; 7-17 years of age). Trajectories of interviewer-rated anxiety symptoms were assessed across 12 weeks of treatment at baseline, 4 weeks, 8 weeks, and 12 weeks. Consistent with models of temperamental risk for mental health problems, negative affectivity predicted higher anxiety symptoms at intake. A significant diathesis-stress interaction between cumulative risk and coping efficacy emerged, as high risk and perceptions of lower coping efficacy attenuated declines in anxiety across 12 weeks. These patterns did not differ across treatment conditions. The results indicate that for youth experiencing high levels of stress, additional treatment efforts targeting familial stressors and coping efficacy may be important in maximizing treatment outcomes.

This pilot study investigated the potential to utilize adaptive treatment strategies for treating moderate to severe suicidal risk among college students. This article will describe the unique study design and report on feasibility and acceptability findings. A 2-stage Sequential Multiple Assignment Randomized Trial (SMART) was conducted: In Stage 1, 62 suicidal college students were randomized to either a suicide-focused or a treatment-as-usual condition (4-8 weeks). Those deemed insufficient responders were re-randomized to one of two Stage 2 interventions-both suicide-focused but one comprehensive and multimodal and the other flexible and theoretically agnostic (4-16 additional weeks). Recruitment rates were high, treatment dropout levels were lower than expected for the setting, study dropouts were rare, and counselors were able to deliver suicide-focused approaches with fidelity. Treatment satisfaction was high among clients and moderately high among counselors. Findings from this pilot show that a SMART is highly feasible and acceptable to suicidal college students, counselors, and campuses.

Objective Exposure tasks are recognized widely as a key component of cognitive-behavioral therapy (CBT) for child and adolescent anxiety. However, little research has examined specific exposure characteristics that predict outcomes for youth with anxiety and that may guide its application in therapy. Method This study draws on a sample of 279 children and adolescents (48.4% male; 79.6% white) with a principal anxiety disorder who received 14 sessions of CBT, either alone or in combination with medication, through the Child/adolescent Anxiety Multimodal treatment Study (CAMS). The present study examines therapist-reported quantity, difficulty level, compliance, and mastery of exposure tasks as they related to CBT response (i.e., Clinical Global Impressions−Improvement ratings). Secondary treatment outcomes included reduction in anxiety symptom severity on the Pediatric Anxiety Rating Scale, global impairment measured via the Children’s Global Assessment Scale, and parent-report of anxiety-specific functional impairment on the Child Anxiety Impairment Scale. Results Regression analyses indicated a dose–response relationship between therapist-reported quantity of exposure and independent evaluations of treatment outcome, with more time devoted to exposure linked to better outcomes. Similarly, greater time spent on more difficult (rather than mild or moderate) exposure tasks predicted better outcomes, as did therapist ratings of child compliance and mastery. Conclusion The present findings highlight the importance of challenging children and adolescents with difficult exposure tasks and of collaborating to ensure compliance and mastery.

Although research has consistently linked unidimensional anxiety with Trichotillomania (TTM) severity, the relationships between TTM severity and anxiety dimensions (i.e., cognitive and somatic anxiety) are unknown. This knowledge gap limits current TTM conceptualization and treatment. The current study examined these relationships with data collected from ninety-one adults who participated in a randomized clinical trial for TTM treatment. To examine whether the Beck Anxiety Inventory (BAI; Beck, Epstein, Brown, & Steer, 1988) could be used to measure multidimensional anxiety in TTM samples, we conducted a factor analysis. Results showed four emergent factors, including a cognitive factor and three somatic factors (neurophysiological, autonomic, and panic). Based on prior research, it was hypothesized that TTM severity would be related to the cognitive anxiety dimension and that psychological inflexibility would mediate the association. Hypotheses were not made regarding the relationship between TTM severity and somatic anxiety. Regression analyses indicated that only cognitive dimensions of anxiety predicted TTM severity and that psychological inflexibility mediated this relationship. Implications for the conceptualization and treatment of TTM are discussed.

Cognitive behavioral therapy (CBT) and selective serotonin reuptake inhibitors are effective treatments for pediatric anxiety disorders. However, the mechanisms of these treatments are unknown. Previous research indicated that somatic symptoms are reduced following treatment, but it is unclear if their reductions are merely a consequence of treatment gains. This study examined reductions in somatic symptoms as a potential mediator of the relationship between treatment and anxiety outcomes. Participants were 488 anxious youth ages 7-17 (M = 10.7), 50.4% male, 78.9% Caucasian, enrolled in Child/Adolescent Anxiety Multimodal Study, a large randomized control trial comparing 12-week treatments of CBT, sertraline, a combination of CBT and sertraline, and a pill placebo. Causal mediation models were tested in R using data from baseline, 8-, and 12-week evaluations. Somatic symptoms were assessed using the Panic/Somatic subscale from the Screen for Child Anxiety Related Emotional Disorders. Youth outcomes were assessed using the Pediatric Anxiety Rating Scale and Children's Global Assessment Scale. Reductions in somatic symptoms mediated improvement in anxiety symptoms and global functioning for those in the sertraline-only condition based on parent report. Conditions involving CBT and data based on child reported somatic symptoms did not show a mediation effect. Findings indicate that reductions in somatic symptoms may be a mediator of improvements for treatments including pharmacotherapy and not CBT. Although the overall efficacy of sertraline and CBT for anxiety may be similar, the treatments appear to function via different mechanisms.

OBJECTIVE: This study examined the relationship between caregivers’ and youths’ treatment expectations and characteristics of exposure tasks (quantity, mastery, compliance) in cognitive-behavioral therapy (CBT) for childhood anxiety. Additionally, compliance with exposure tasks was tested as a mediator of the relationship between treatment expectations and symptom improvement. METHOD: Data were from youth (N= 279; 7–17 years old) enrolled in the Child/Adolescent Anxiety Multimodal Study (CAMS) and randomized to cognitive-behavioral therapy (CBT) or the combination of CBT and sertraline for the treatment of separation anxiety disorder, generalized anxiety disorder, and social phobia. Caregivers and youth independently reported treatment expectations prior to randomization, anxiety was assessed at pre- and post-treatment by independent evaluators blind to treatment condition, and exposure characteristics were recorded by the cognitive-behavioral therapists following each session. RESULTS: For both caregivers and youths, more positive expectations that anxiety would improve with treatment were associated with greater compliance with exposure tasks, and compliance mediated the relationship between treatment expectations and change in anxiety symptoms following treatment. Additionally, more positive parent treatment expectations were related to a greater number and percentage of sessions with exposure. More positive youth treatment expectations were associated with greater mastery during sessions focused on exposure. CONCLUSIONS: Findings underscore the importance of addressing parents’ and youths’ treatment expectations at the outset of therapy to facilitate engagement in exposure and maximization of therapeutic gains.

The current study examined prospective bidirectional links between dysregulated sleep, and anxiety and depression severity across four years, among youth with a history of anxiety disorder. Participants were 319 youth (age 11-26 years), who previously participated in a large multisite randomized controlled trial for the treatment of pediatric anxiety disorders, Child/Adolescent Anxiety Multimodal Study (CAMS), and subsequently enrolled in a naturalistic follow-up, Child/Adolescent Anxiety Multimodal Extended Long-term Study (CAMELS), an average of 6.5 years later. They participated in four annual visits that included self-report items of dysregulated sleep and semi-structured multi-informant interviews of anxiety and depression. Dysregulated sleep was bidirectionally associated with clinician-rated anxiety and depression symptom severity across adolescence and young adulthood. However, these bidirectional relationships were attributable to youth mean levels of dysregulated sleep, and anxiety and depression severity over the four years. Elevations in dysregulated sleep at each visit, relative to mean levels, did not predict worse anxiety or depression severity one year later. Likewise visit-specific elevations in anxiety and depression severity, as opposed to average levels, did not predict higher levels of dysregulated sleep at the next visit. Having higher levels of dysregulated sleep or more severe internalizing problems across the four-year period, as opposed to reporting a relative increase in symptom severity at a particular visit, posed greater risk for poor mental health. Interventions should continue to assess and treat persistent sleep problems alongside anxiety and depression.

Phenomenon: Virtual standardized patients (vSPs) are becoming increasingly common in medical education, though one limitation of vSPs is the artificiality of computer-based simulators. Past research on the use of vSPs has not clearly established whether learners have different emotional responses to real SPs (rSPs) compared with vSPs; however, understanding learners' emotional responses to vSPs is important in providing realistic learning experiences and establishing the validity of this teaching and assessment tool. This study compared the emotional experiences of individuals who interacted with rSPs and vSPs. Approach: Sixty medical students at a medical school in the southeastern United States participated in the study. Participants were randomly assigned to deliver bad news to an rSP or vSP. The vSP for this study used a hybrid intelligence model that allowed a person to "inhabit" the vSP. Salivary cortisol and a self-report measure of mood-the Profile of Mood States, Second Edition (POMS 2)-were gathered before and after delivering the bad news. The SP and 2 independent evaluators rated the behavioral performance of each participant in real and virtual conditions. Participants also rated the performance of the SP. Findings: Participants in both conditions reported increased negative emotionality on the POMS 2 following the SP interaction. There were no significant between-group differences on the POMS 2 or salivary cortisol concentration following the SP interaction. Ratings by the SP and independent evaluators indicated that participants performed similarly on most interpersonal dimensions, except tone of voice. Participants perceived the vSP as less realistic than the rSP. Insights: These results suggest that medical students may have similar emotional and behavioral responses when delivering bad news to a vSP when compared to an rSP. These findings provide support for the continued use of vSPs in training learners to deliver bad news and other communication-based skills and to assess their performance on these tasks.

Trichotillomania (TTM) involves the chronic pulling out of hair to the point of hair loss or thinning, which continues despite repeated attempts to stop. Behavior therapy is a promising treatment for the condition, but studies have been limited by the lack of a credible control condition, small sample sizes, follow-up periods of short duration, and low participation by underrepresented populations. In the current article, the authors describe the theoretical rationale for an acceptance-enhanced form of behavior therapy for TTM in adults and describe the methodology used to test the efficacy of this intervention against a psychoeducation and supportive control condition. In addition, the authors discuss the importance of and difficulties encountered with enrolling minority participants into TTM research, as well as strategies used to enhance minority recruitment. Finally, the authors discuss the instruments, procedures, and related outcomes of the fidelity measures used in the randomized controlled trial.

OBJECTIVE: Latent Profile Analysis (LPA) was used to derive homogeneous subgroups within the Child/Adolescent Anxiety Multimodal Study sample (CAMS; N=488; 7–17 years, M=10.69, SD=2.80), and examine whether class membership predicted or moderated treatment response. METHOD: Subgroups were identified on baseline multi-informant measures of variables most consistently associated with outcome (youth anxiety/diagnosis, impairment, family psychopathology/functioning). Subgroup membership was examined as a predictor/moderator of outcome across the four treatment conditions (CBT, Sertraline, CBT+Sertraline, pill placebo) at posttreatment (12-weeks) and open-extension follow-up (24-weeks). RESULTS: Four subgroups emerged: mild symptoms/impairment, moderate symptoms/impairment, moderate symptoms/impairment with family dysfunction/parental psychopathology, and severe symptoms/impairment. There were significant between-class differences on socioeconomic status (SES; lower reported SES in the moderate with family dysfunction/parental psychopathology class compared to the mild and moderate class) and age (older age in the severe symptoms class compared to the other three classes). Youth in the mild symptoms/impairment class showed lower post-treatment anxiety across conditions, but reported significantly lower symptom severity at baseline. Controlling for demographic differences, response to treatment type did not differ across classes. CONCLUSIONS: Analyses indicate that elevated family dysfunction/parental psychopathology clusters primarily within one subgroup of anxious youth rather than mapping onto symptom severity, highlighting the utility of LPA for clarifying within-person combinations of predictor/moderator variables. Implications for development of interventions targeting class-relevant variables are discussed.

BACKGROUND: Controlled evaluations comparing medication, cognitive-behavioral therapy (CBT), and their combination in the treatment of youth anxiety have predominantly focused on global ratings by independent evaluators. Such ratings are resource-intensive, may be of limited generalizability, and do not directly inform our understanding of treatment responses from the perspective of treated families. We examined outcomes from the perspective of treated youth and parents in the Child/Adolescent Anxiety Multimodal Study (CAMS). METHODS: Participants (N=488; ages 7–17 years) who had a primary diagnosis of separation, social, and/or generalized anxiety disorder were randomly assigned to a treatment condition in the CAMS trial. Linear mixed-effects and ANCOVA models examined parent- and youth-reported anxiety symptoms, impact of anxiety, broader internalizing and externalizing psychopathology, depressive symptoms, and family burden throughout the 12-week acute treatment phase and 6-month follow-up. RESULTS: At week 12, combination treatment showed superiority over placebo, sertraline, and CBT with regard to parent-reported youth anxiety symptoms, and sertraline and CBT as monotherapies showed superiority over placebo with regard to parent-reported youth anxiety. Combination therapy and sertraline also showed week 12 superiority over placebo with regard to parent-reported internalizing psychopathology, and superiority over placebo and CBT with regard to parent-reported impact of anxiety, family burden, and youth depressive symptoms. By week 36, parent reports of many youth outcomes were comparable across active conditions. Youth measures tracked parent measures on many outcomes. CONCLUSIONS: Findings were drawn on brief, readily available questionnaires that in conjunction with clinician measures can inform patient-centered care and collaborative decision-making. Trial Registry Name: Child and Adolescent Anxiety Disorders (CAMS) Registry identification number: NCT00052078 Registry URL: https://www.clinicaltrials.gov/ct2/show/NCT00052078

Some have argued that hair pulling in trichotillomania (TTM) is triggered by traumatic events, but reliable evidence linking trauma to TTM is limited. However, research has shown that hair pulling is associated with emotion regulation, suggesting a connection between negative affect and TTM. We investigated the associations between trauma, negative affect, and hair pulling in a cross-sectional sample of treatment seeking adults with TTM (N=85). In the current study, participants’ self-reported traumatic experiences were assessed during a structured clinical interview, and participants completed several measures of hair pulling severity, global TTM severity, depression, anxiety, experiential avoidance, and quality of life. Those who experienced trauma had more depressive symptoms, increased experiential avoidance, and greater global TTM severity. Although the presence of a trauma history was not related to the severity of hair pulling symptoms in the past week, depressive symptoms mediated the relationship between traumatic experiences and global TTM severity. These findings cast doubt on the notion that TTM is directly linked to trauma, but suggest that trauma leads to negative affect that individuals cope with through hair pulling. Implications for the conceptualization and treatment of TTM are discussed.

The Milwaukee Inventory for Subtypes of Trichotillomania-Adult Version (MIST-A; Flessner et al., 2008) measures the degree to which hair pulling in Trichotillomania (TTM) can be described as "automatic" (i.e., done without awareness and unrelated to affective states) and/or "focused" (i.e., done with awareness and to regulate affective states). Despite preliminary evidence in support of the psychometric properties of the MIST-A, emerging research suggests the original factor structure may not optimally capture TTM phenomenology. Using data from a treatment-seeking TTM sample, the current study examined the factor structure of the MIST-A via exploratory factor analysis. The resulting two factor solution suggested the MIST-A consists of a 5-item "awareness of pulling" factor that measures the degree to which pulling is done with awareness and an 8-item "internal-regulated pulling" factor that measures the degree to which pulling is done to regulate internal stimuli (e.g., emotions, cognitions, and urges). Correlational analyses provided preliminary evidence for the validity of these derived factors. Findings from this study challenge the notions of "automatic" and "focused" pulling styles and suggest that researchers should continue to explore TTM subtypes.

Trichotillomania (TTM) is associated with significant embarrassment and is viewed negatively by others. A potentially important outcome variable that is often overlooked in treatment for TTM is appearance and social perception.The present study tested whether participants in a randomized controlled trial (RCT) of psychotherapy for TTM are viewed more positively by others. All participants in the trial were photographed at baseline and posttreatment. Three treatment responders and three treatment nonresponders were selected randomly for the present study. Several healthy controls were also photographed in a similar manner. Undergraduate college students (N = 245) assessed whether they would reject the person socially, whether the individual has a psychological or medical problem, and attractiveness.Individuals with TTM were viewed more negatively than healthy controls at baseline, but treatment responders showed positive improvements on all perceptions relative to nonresponders. While treatment responders were still perceived more poorly than controls on social rejection and perceptions of problems at posttreatment, responders where rated no differently than controls on attractiveness at posttreatment.The results suggest that persons with TTM who respond to treatment are rated by others as significantly improved in appearance, but they might be still stigmatized or socially rejected.

Although photographic assessment has been found to be reliable in assessing hair loss in Trichotillomania, the validity of this method is unclear, particularly for gauging progress in treatment. The current study evaluated the psychometric properties of photographic assessment of change in Trichotillomania. Photographs showing hair loss of adults with Trichotillomania were taken before and after participating in a clinical trial for the condition. Undergraduate college students (N = 211) rated treatment response according to the photos, and additional archival data on hair pulling severity and psychosocial health were retrieved from the clinical trial. Photographic assessment of change was found to possess fair reliability (ICC = 0.53), acceptable criterion validity (r = 0.51), good concurrent validity (r = 0.30–0.36), and excellent incremental validity (ΔR 2 = 8.67, p

Objective Standard assessment of pediatric obsessive-compulsive disorder (OCD) patients includes ratings of insight, avoidance, indecisiveness, sense of responsibility, pervasive slowness, pathological doubting, and obsession-free intervals. The present study aims to identify pre-treatment associations of these clinical features to symptom severity and symptom dimensions as well as to describe and analyze the long-term levels and distribution in different treatment responder groups. Method: Severity ratings as well as clinical feature ratings were evaluated in 268 pediatric OCD patients using the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) at seven time points before, during, and up to three years after first-line cognitive-behavioral therapy. The CY-BOCS auxiliary items were evaluated on the basis of three symptom severity trajectory classes: acute, slow, and limited responders. Results: Insight, avoidance, pervasive slowness, and obsession-free intervals were positively associated with pre-treatment symptom severity. Symptom dimensions were associated with different auxiliary items. At three-year follow-up, the limited responder class had higher scores than the acute and slow responder classes on all items except for responsibility. Conclusion: The CY-BOCS auxiliary items are closely related to symptom dimensions and partly to symptom severity. The features appear to be dynamic concepts prone to change, yet, less so in patients showing limited long-term treatment response.

Objective To evaluate whether umbilical cord blood (CB) infusion is safe and associated with improved social and communication abilities in children with autism spectrum disorder (ASD). Study design This prospective, randomized, placebo-controlled, double-blind study included 180 children with ASD, aged 2-7 years, who received a single intravenous autologous (n = 56) or allogeneic (n = 63) CB infusion vs placebo (n = 61) and were evaluated at 6 months postinfusion. Results CB infusion was safe and well tolerated. Analysis of the entire sample showed no evidence that CB was associated with improvements in the primary outcome, social communication (Vineland Adaptive Behavior Scales-3 [VABS-3] Socialization Domain), or the secondary outcomes, autism symptoms (Pervasive Developmental Disorder Behavior Inventory) and vocabulary (Expressive One-Word Picture Vocabulary Test). There was also no overall evidence of differential effects by type of CB infused. In a subanalysis of children without intellectual disability (ID), allogeneic, but not autologous, CB was associated with improvement in a larger percentage of children on the clinician-rated Clinical Global Impression-Improvement scale, but the OR for improvement was not significant. Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power. Conclusions Overall, a single infusion of CB was not associated with improved socialization skills or reduced autism symptoms. More research is warranted to determine whether CB infusion is an effective treatment for some children with ASD.