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Importance: In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment. Objective: To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder. Design, Setting and Participants: A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020. Interventions: Participants randomized to the stepped-care group (n=74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n=78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment. Main Outcomes and Measures: The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0(no symptoms) to 4(extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS. Results: Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face tr

Background: Anxiety disorders in children and young people are common and bring significant personal and societal costs. Over the last two decades, there has been a substantial increase in research evaluating psychological and pharmacological treatments for anxiety disorders in children and young people and exciting and novel research has continued as the field strives to improve efficacy and effectiveness, and accessibility of interventions. This increase in research brings potential to draw together data across studies to compare treatment approaches and advance understanding of what works, how, and for whom. There are challenges to these efforts due largely to variation in studies’ outcome measures and variation in the way study characteristics are reported, making it difficult to compare and/or combine studies, and this is likely to lead to faulty conclusions. Studies particularly vary in their reliance on child, parent, and/or assessor-based ratings across a range of outcomes, including remission of anxiety diagnosis, symptom reduction, and other domains of functioning (e.g., family relationships, peer relationships). Methods: To address these challenges, we convened a series of international activities that brought together the views of key stakeholders (i.e., researchers, mental health professionals, young people, parents/caregivers) to develop recommendations for outcome measurement to be used in treatment trials for anxiety disorders in children and young people. Results and Conclusions: This article reports the results of these activities and offers recommendations for selection and reporting of outcome measures to (a) guide future research and (b) improve communication of what has been measured and reported. We offer these recommendations to promote international consistency in trial reporting and to enable the field to take full advantage of the great opportunities that come from data sharing going forward.

Background: One in twenty adolescents experience excessive worry and evidence-based psychological therapies are not sufficiently widespread to reach most of those affected. In this multiple baseline evaluation, we assess the feasibility and preliminary efficacy of a scalable, online cognitive-behavioral intervention for adolescents with excessive worry (BIP worry). Methods: Thirteen adolescents (age 13–17) with excessive worry underwent the 10-week online BIP worry intervention. The treatment also included an online intervention for parents. Completion rates, treatment satisfaction, and adverse events were measures of feasibility. Clinical outcomes included worry severity, symptoms of other anxiety and depression, and general functioning. To control for time and spontaneous fluctuations in symptoms, adolescents were randomized to a 2-, 6-, or 10-week baseline phase prior to treatment. A short measure of worry severity was administered weekly during the baseline and treatment phases. Outcomes were assessed before the baseline-phase, at pre-treatment, post-treatment, and at 1- and 3-month follow-ups. Results: Twelve of 13 included adolescents, together with their parents, participated in BIP worry, with a mean completion rate of 9.8 of the 10 treatment modules. Adolescents reported an average of 4.4 exposures per week as homework during treatment. High levels of treatment adherence, credibility, and satisfaction, and no serious adverse events were reported. Therapists averaged 21 min per week communicating with each family. Linear mixed effects models indicated significant improvements in worry, anxiety, and general functioning from pre- to post-treatment, with these gains maintained at 1- and 3-months follow-up. Reductions in worry severity during treatment were significantly larger than during the baseline phase. The results from the multiple baseline evaluation suggested an association between the introduction of the BIP worry intervention and subsequent symptom ch, This work was supported by the Swedish Research Council for Health, Working Life and Welfare (Forte 2014-4052) and Stockholm County Council (HNSV 14099). Eva Serlachius was supported by the Stockholm County Council (clinical research appointment, grant number 20170605).

Background: Paediatric anxiety disorders are common, impairing and associated with a societal and economic burden. Even though there are efficacious treatments to treat these disorders, access to them are limited. Internet-delivered cognitive behaviour therapy (ICBT) has gained support for being an efficacious treatment for paediatric anxiety disorders and is suggested as one possible solution to increase access to evidence-based treatments. Aims and methods: The main aim of this thesis was to evaluate the BiP Anxiety programme, for children aged 8 to 12 years old with an anxiety disorder, in two clinical settings. First by con­ducting a randomised controlled trial within a specialised ICBT clinic part of the child and adolescent mental health services (CAMHS) in Stockholm. Secondly by conduct­ing a pilot feasibility trial at a CAMHS outpatient clinic in rural Sweden. Specific aims were to evaluate (1) the effects and cost-effectiveness ofICBT compared to an active placebo control, (2) the long term effect of ICBT within a stepped-care model where non-remitters of treatment were offered additional treatment, (3) predictors of treatment outcome, and ( 4) the feasibility and potential effectiveness ofICBT when disseminated in an outpatient clinic in rural Sweden. Results: ICBT was effective in reducing anxiety symptoms in a cost-effective manner when compared to a placebo condition controlling for non-specific therapeutic factors such as attention and weekly homework assignments. Treatment gains were maintained up to 12 months after the end of the treatment. Participants with a principal diagnosis of separation anxiety disorder, and those more engaged in behaviour change were more likely to be in remission at the three-months follow-up. Participants with more severe anxiety were less likely of being in remission. Additional face-to-face treatment for non-remitters ofICBT was efficacious for those receiving it. The majority of non-remitters however declined this offer

Background: Paediatric anxiety disorders are prevalent and associated with substantial disability and long-term adverse consequences. Only a minority of affected children have access to evidence-based treatment; internet-delivered cognitive behaviour therapy (ICBT) could help increase accessibility but needs further rigorous evaluation. The objective of this trial was to evaluate the clinical efficacy and cost-effectiveness of ICBT in the treatment of paediatric anxiety disorders. Methods: In this single-blind randomised controlled trial, children 8-12 years with a principal anxiety disorder diagnosis were randomly allocated (1:1) to ICBT or internet-delivered child-directed play (ICDP), an active comparator aimed to improve parent-child relationships and increase child self-esteem without directly targeting anxiety. The study was conducted at a single site within the Stockholm specialist child and adolescent mental health services (CAMHS). Primary endpoint was clinician-rated symptom severity (CSR) of the principal anxiety disorder at post-treatment. All participants were included in the primary analysis (intent-to-treat). Trial registration number: NCT02350257. Findings: Participants (N=131) were recruited between March 2015 and October 2016, mainly via advertisement and referrals from CAMHS, and allocated to ICBT (n=66) or ICDP (n=65). Analyses revealed greater reduction of symptom severity in favour of ICBT (mean difference 0·79, 95% CI 0·42 to 1·16, p=0·002; Cohen’s d=0·77, 95% CI 0·40 to 1·15) and at post-treatment, 48% (n=29) of participants randomised to ICBT no longer fulfilled their principal diagnosis, compared to 15% (n=9) in ICDP (odds ratio 5·41, 95% CI 2·26 to 12·90, p<0·0001). Numbers needed to treat were 3 (95% CI 2·85 to 3·15). Treatment gains were maintained at 3-month follow-up, at which point 70% (n=40) of participants randomised to ICBT no longer met the criteria for their principal anxiety disorder. ICBT resulted in an average societal cost sa

Background: Paediatric anxiety disorders are associated with substantial disability and long-term adverse consequences, but only a small proportion of affected children have access to evidence-based treatment. Internet-delivered cognitive behavioural therapy (ICBT) could help increase accessibility but needs further rigorous assessment. We aimed to assess the efficacy and cost-effectiveness of ICBT in the treatment of paediatric anxiety disorders. Methods: We did a single-blind randomised controlled trial in a clinical research unit within the Child and Adolescent Mental Health Services in Stockholm (Sweden). Eligible participants were children aged 8-12 years with a diagnosis of a principal anxiety disorder (seperation anxiety disorder, generalised anxiety disorder, specific phobia, social anxiety disorder, or panic disorder) of at least moderate severity. We randomly allocated participants (1:1) to ICBT or internet-delivered child-directed play, an active comparator aimed to improve parent child relationships and increase a child's self-esteem without directly targeting anxiety. Block sizes for the randomisation varied between four and six and were generated using a computer random-number generator, and the allocation was concealed from the researchers by opaque sealed envelopes. Both treatment programmes comprised 12 modules presented over 12 weeks with weekly asynchronous online therapist support, and consisted of texts, films, illustrations, and exercises. The primary outcome was severity rating of the principal anxiety disorder 12-weeks post-treatment, via the Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders-IV (a rating of at least 4 corresponds to meeting the criteria for the principal diagnosis), assessed by clinicians masked to treatment allocation. All participants were included in the primary analysis (intention-to-treat). This trial is registered at ClinicalTrials.gov, number NCTO 2350257. Findings: Between M