Clinical trial NCT03473080: An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
Official title: Feasibility of a Therapist and Parent Guided eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
ASD
Obsessive Compulsive Disorder
Autism Spectrum Disorder
ICBT
eHealth
Internet
CBT
Pediatric
Adolescents
Children
Internet-delivered
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 22
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a feasibility study of Internet-delivered CBT for OCD in children and adolescents (7-17 years) with comorbid Autism Spectrum Disorder.

Detailed description: The main objectives of this study is to evaluate the feasibility, acceptability and preliminary efficacy of internet-delivered Cognitive Behavioral Therapy (ICBT) for Obsessive Compulsive Disorder (OCD) in children and adolescents (7-17 years) with Autism Spectrum Disorders (ASD). The study will an open trial with-in group mean comparison design (n=18). The treatment is delivered over 16 weeks. Study participants will be followed up at 3 (primary endpoint), 6 and 12 months after completed treatment. ICBT is expected to decrease OCD-symptoms.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of OCD according to DSM-5
* a diagnosis of autism according to DSM-IV or DSM-5, confirmed with the Autism Diagnostic Interview- Revised or Autism Diagnostic Observation Schedule version 1 or 2 and by medical records
* a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale
* age between 7 and 17 years
* ability to read and write Swedish
* access to the internet
* a parent that is able to co-participate in the treatment
* participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* a diagnosis of psychosis, bipolar disorder, severe eating disorder or intellectual disabilities
* comorbid hoarding disorder or OCD with hoarding as a principal symptom.
* suicidal ideation
* subject not able to read or understand the basics of the ICBT material
* completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
* ongoing psychological treatment for OCD or any anxiety disorder
* OCD treatment is not an immediate priority

Primary outcomes:
measure: Children's Yale-Brown Obsessive Compulsive Scale
timeFrame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary outcomes:
measure: Obsessive-compulsive inventory - child version
timeFrame: Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
measure: Autism spectrum quotient (AQ-10)
timeFrame: Baseline
measure: Education, work and social adjustment scale - child and parent version
timeFrame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
measure: Family accommodation scale for obsessive-compulsive disorder
timeFrame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
measure: Mood and Feeling Questionnaire - child and parent version
timeFrame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
measure: Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P)
timeFrame: Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
measure: Mini International Neuropsychiatric Interview for Children and Adolescents
timeFrame: Baseline
measure: Children's global assessment scale
timeFrame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
measure: Children's Assessment Scale for Developmental Disabilities
timeFrame: Baseline
measure: Clinical global impression - severity
timeFrame: Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
measure: Clinical global impression - improvement
timeFrame: 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
measure: internet intervention Patient Adherence Scale
timeFrame: 8 weeks, 16 weeks
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 16 weeks
measure: Parent strategies
timeFrame: Post-treatment
measure: Patient EX/RP Adherence Scale
timeFrame: Weekly for 16 weeks (during treatment)
measure: Drop-out rate from treatment
timeFrame: at week 16
measure: Completed treatment modules
timeFrame: week 16
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: BUP OCD and Related Disorders
Study officials:
affiliation: Karolinska Institutet
name: Fabian Lenhard, PhD
role: PRINCIPAL_INVESTIGATOR
References: