iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

Study Overview
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Brief Summary
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Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 6 to 18 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data. The investigators have already successfully performed a feasibility study.The goal of the current proposal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of the feasibility study. Internal testing on iCBT therapy package and developmental workchanges has been done. The investigators are now evaluating effectiveness in an RCT.

Detailed Description
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In this study the investigators test effectiveness of an internet-based therapy approach for children with obsessive-compulsive disorders in an RCT design with a waiting control group. The investigators are planninng the investigation of 20 patients in each group.Therapy is verified by experts via teleconferences and a therapy app. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list-group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I) and 64 weeks after the first randomization (follow-up II).

Official Title
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Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder II

Conditions
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Psychotherapy Intervention Evaluation

Intervention / Treatment
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* Behavioral: Cognitive-behavioral psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents (ages 6-18) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker German-speaking (child & caretakers) Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone written informed content of the child and his caretaker OCD as highest treatment priority Exclusion Criteria: IQ below 70 not speaking and understanding German A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based psychotherapy<br>16 weeks of internet-based cognitive behavioral therapy | Behavioral: Cognitive-behavioral psychotherapy<br>* The goal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of our feasibility study. This group will start directly with therapy of 16 weeks. The waiting group gets the same intervention after 16 weeks of waiting.<br>|
| Active Comparator: Internet-based psychotherapy waiting group<br>16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks | Behavioral: Cognitive-behavioral psychotherapy<br>* The goal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of our feasibility study. This group will start directly with therapy of 16 weeks. The waiting group gets the same intervention after 16 weeks of waiting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL) | Clinical interview for psychiatric disorders for children and parents. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | Interview/questionnaire for obsessive-compusive disorders. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Children's Global Assessment Scale (CGAS) | The CGAS is a measure of level of functioning in children and adolescents. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Child Behavior Checklist (CBCL/6-18R) | A 113-item 3-point questionnaire for parents that assesses a wide range of child behavioral and emotional problems. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL) | A 24 item 5 point scale self-report questionnaire for children and parents to quality of life. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC) | A 33-item self-report questionnaire to the impact of OCD symptoms on the psychosocial functioning of the children. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Youth Self-Report (YSR/11-18R) | A 112 item 3-point scale completed by the children themselves and addresses a variety of behavioral and emotional problems. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Depression Inventory for Children and Adolescents (DIKJ) | The questionnaire measures depressive symptoms in the children. It has 26 items and a 4 point scale. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Junior temperament and character inventory (JTCI) | The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) | The SCARED assesses DSM-IV anxiety symptoms. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Clinical Global Impressions-Severity (CGI-S) | A clinical 7-point rating scale of symptom severity. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Clinical Global Impressions-Improvement (CGI-I) | A clinical 7-point rating scale of symptom severity. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Impairment by OCD symptoms | Children and parents indicate impairment by OCD via app. | Every day throughout the therapy process | 
| Change in Extend of avoidance behavior | Children and parents indicate extend of avoidance behavior via app. | Every day throughout the therapy process | 
| Change in Daily mood | Children indicate their mood via app. | Every day throughout the therapy process | 
| Change in How the day has been | Children indicate how good the day has been via app. | Every day throughout the therapy process | 
| Change in How strong OCD is | Children and parants indicate how strong OCD is via app. | Every day throughout the therapy process | 
| Change in How the week has been | Children and parants indicate how the week has been via app. | weekly throughout the therapy process | 
| Change in Anxiety ratings during exposures | Children indicate how high anxiety was during exposures via app. | Every exposure throughout the therapy process | 
| Change in Heart rate variability | Heart rate variability as an indicator of stress levels is assessed with wristbands. | Every day throughout the therapy process | 
| Change in time the OCD takes | Children and parants indicate how much time OCD takes via app. | Every day throughout the therapy process | 
| Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R) | This questionnaire assesses the core personality traits of children. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in Engagement- Fragebogen | Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 
| Change in How convinced the patient of his/her OCD thoughts is | assessed by App | every exposure | 
| Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE) | Questionnaire to life quality of parents related to the impairment through the illness of the child. | baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive-behavioral psychotherapy, obsessive-compulsive disorder, internet-based