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Objective To compare the effectiveness of a 4-week precision vestibular rehabilitation intervention compared with a behavioral management control intervention for adolescents with vestibular symptoms/impairment within 21 days of a concussion. Study design This study used double-blind, randomized controlled trial design involving adolescent (12-18 years) patients with a diagnosed sport/recreation-related concussion with vestibular symptoms/impairment from a concussion-specialty clinic between October 2018 and February 2020. Eligible participants were randomized in a 1:1 to either a 4-week vestibular intervention group (VESTIB) or a behavioral management control group (CONTROL). CONTROLS (n = 25) were prescribed behavioral management strategies (eg, physical activity, sleep, hydration, nutrition, stress management) and instructed to perform stretching/physical activity (eg, walking, stationary cycle) 30 minutes/day. VESTIB (n = 25) were prescribed precision vestibular rehabilitation exercises and instructed to perform at-home exercises for 30 minutes/day. Primary outcomes were improvement in Vestibular/Ocular Motor Screening vestibular items (ie, horizontal/vertical vestibular-ocular reflex, visual motion sensitivity) at 4 weeks postenrollment. Results We screened 310 and enrolled a total of 55 (18%) adolescent patients who were randomized to one of the interventions. Fifty of fifty-five (91%) participants completed all aspects of the study protocol. Participants in VESTIB improved significantly across the intervention period in horizontal (mean difference-1.628; 95% CI [-3.20, −0.06]; P = .04) and vertical (mean difference-2.24; 95% CI [-4.01, −0.48]; P = .01) vestibular-ocular reflex, but not visual motion sensitivity (mean difference-2.03; 95% CI [-4.26, 0.19]) of the Vestibular/Ocular Motor Screening score compared with CONTROLS. Conclusions Overall, the vestibular intervention group experienced greater clinical improvements in vestibular symptoms/impairment than controls across the 4-week intervention. Trial Registration ClinicalTrials.gov : NCT03555370.

Background Problems with sustained attention, impulsivity, and hyperactivity are the most prominent symptoms of attention-deficit hyperactivity disorder (ADHD), but many children with this diagnosis also present with poor organizational skills that are important in relation to school. These problems tend to increase from childhood to adolescence and are often not well managed by medication. Organizational skills training (OST) is a range of behavioral interventions that specifically target organizational skills deficits. Evidence supports the effect of OST on improving organizational skills, inattention, and academic performance in children with ADHD. Because previous clinical trials included mostly children above the age of 8 years, this trial includes children in the age range 6–13 years to expand the knowledge on the effects of OST in younger children. Previous OST research has also shown improvement on inattention in parent ratings; we will investigate if a change in inattention can be confirmed with neurocognitive tests. Finally, little is known about predictors of treatment response in OST. Objectives The primary objective is to investigate if OST has positive effects on organizational skills in children with ADHD. The primary outcome measurement is the parent-rated Children’s Organizational Skills Scale (COSS), collected before and at the end of the 10 week intervention. Secondary and exploratory outcomes include inattention ratings, family and school functioning, and cognitive functions measured before the intervention period, immediately after, and at a 6 month follow-up. Additional objectives are to investigate both neurocognitive outcomes and age as predictors of treatment response. Methods This is a randomized clinical superiority trial investigating the effect of OST vs a treatment-as-usual (TAU) control group for children with ADHD in the age range of 6–13 years. All participants (n = 142) receive TAU. OST is administered in a group format of 10 weekly sessions. Adverse events are monitored by study clinicians during weekly therapy sessions and all assessments. Data analyses will be conducted using mixed linear regression models with random intercepts for patients, adjusted for the stratification variables and the baseline value. Perspectives This study will provide important new knowledge and expand on existing research in the field of non-pharmacological treatment of children with ADHD. OST can potentially have a significant impact on the lives of children with ADHD by helping them learn how to cope with their present deficits and to become more independent and self-reliant. It is also important to investigate predictors of treatment response in order to optimize OST. Trial registration ClinicalTrials.gov NCT03160378. Registered on May 19, 2017.

BackgroundProgress feedback provides therapists with progress notes on a regular basis through the continuous assessment of participants throughout their treatment (e.g., symptoms, therapeutic alliance). While for adults the evidence base has increased over the years, progress feedback in the therapy of children and adolescents has not been sufficiently investigated. This manuscript describes the trial protocol of the OPTIE study: a randomized trial that tests the efficacy of a progress feedback system in children and adolescents under conditions of routine care.MethodsThe study is based on a randomized parallel-group trial with two treatment groups (routine, feedback) at an outpatient unit of a university hospital. The target sample size is 439 families consisting of children and adolescents aged 6 to17 years old with internalizing and/or externalizing symptoms. Both the patients and the therapists are independently assigned to the treatment groups by stratified block randomization. In both treatment groups patients receive routine care behavioral therapy for a study-related 12 months; additionally, in the feedback group, a progress feedback system with three components is applied (monitoring, report, and supervision). For three informants (caregiver, child [≥ 11 years], therapist) surveys are conducted every 6 weeks (e.g., symptoms, goals, motivation). For both treatment groups, comparison data is collected at baseline and at six and 12 months after the beginning of the intervention (pre, inter, post), and includes five informants (blinded clinician, therapist, caregiver, child [≥ 11 years], teacher).DiscussionThe OPTIE study will contribute to the evidence base of progress feedback in children and adolescents and has the potential to uncover treatments’ effects in the small to medium range. Noteworthy features are the inclusion of children younger than 10 years old and the consideration of a blinded clinician rating.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00016737 (https://www.drks.de/DRKS00016737). Registered 17 September, 2019.

IMPORTANCE: Social deficits are a common and disabling feature of many pediatric disorders; however, whether behavioral interventions are associated with benefits for children and adolescents with social deficits is poorly understood. OBJECTIVE: To assess whether behavioral interventions in children and adolescents with neurodevelopmental or mental health disorders are associated with improvements in social function and social cognition, and whether patient, intervention, and methodological characteristics moderate the association. DATA SOURCES: For this systematic review and meta-analysis, the PsycINFO, MEDLINE, and PubMed electronic databases were searched in December 2020 for randomized clinical trials published from database inception to December 1, 2020, including terms related to neurodevelopmental or mental health disorders, social behavior, randomized clinical trials, and children and adolescents. Data were analyzed in January 2021. STUDY SELECTION: Randomized clinical trials that enrolled participants aged 4 to 17 years with social deficits and examined the efficacy of a clinician-administered behavioral intervention targeting social functioning or social cognition were included. A total of 9314 records were identified, 78 full texts were assessed for eligibility, and 33 articles were included in the study; 31 of these reported social function outcomes and 12 reported social cognition outcomes. DATA EXTRACTION AND SYNTHESIS: Articles were reviewed using the Cochrane Risk of Bias Assessment for randomized clinical trials. Data were independently extracted and pooled using a weighted random-effects model. MAIN OUTCOMES AND MEASURES: The main outcome was the association of behavioral intervention with social function and social cognition. Hedges g was used to measure the standardized mean difference between intervention and control groups. Standardized effect sizes were calculated for the intervention group vs the comparison group for each trial. RESULTS: A total of 31 trials including 2131 participants (1711 [80%] male; 420 [20%] female; mean [SD] age, 10.8 [2.2] years) with neurodevelopmental or mental health disorders (autism spectrum disorder [ASD] [n = 23], attention-deficit/hyperactivity disorder [n = 4], other conditions associated with social deficits [n = 4]) were analyzed to examine differences in social function between the intervention and control groups. Significantly greater gains in social function were found among participants who received an intervention than among the control groups (Hedges g, 0.61; 95% CI, 0.40-0.83; P

There is a well-established relation between exposure to child maltreatment and the onset and course of multiple, comorbid psychiatric disorders. Given the heterogeneous clinical presentations at the time services are initiated, interventions for children exposed to maltreatment need to be highly effective to curtail the lifelong burden and public health costs attributable to psychiatric disorders. The current review describes the most effective, well-researched, and widely-used behavioral and pharmacological interventions for preventing and treating a range of psychiatric disorders common in children exposed to maltreatment. Detailed descriptions of each intervention, including their target population, indicated age range, hypothesized mechanisms of action, and effectiveness demonstrated through randomized controlled trials research, are presented. Current limitations of these interventions are noted to guide specific directions for future research aiming to optimize both treatment effectiveness and efficiency with children and families exposed to maltreatment. Strategic and programmatic future research can continue the substantial progress that has been made in the prevention and treatment of psychiatric disorders for children exposed to maltreatment.