ICBT for OCD in Children With Autism

Sponsor
Karolinska Institutet
Study ID
NCT06582225
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Internet-delivered exposure and response prevention (I-ERP) — BEHAVIORAL
    The intervention is internet-delivered and therapist-guided, involving the child and at least one caregiver. It consists of two separate sets of modules, one for the child and one for the caregiver. The intervention consists of 12 modules, delivered over a maximum of 14 weeks. The treatment includes psychoeducation about ASD, OCD, emotions, healthy habits, the difference between repetitive behaviours in autism and OCD, how compulsions maintain the obsessions, and the rationale for ERP. The main focus of the treatment is ERP tasks based on the young person's individual goals. The modules also contain homework tasks that are meant to be completed between modules, mainly consisting of ERP. The final module includes a summary of the treatment and a relapse prevention plan. The version for parents consists of the same content as the child treatment, but with elaborated psychoeducation, and additional focus on strategies on how to assist their child in the different exposure tasks.
  • Internet-delivered stress management (I-SM) — BEHAVIORAL
    The intervention is internet-delivered and therapist-guided, involving the child and at least one caregiver. It consists of two separate sets of modules, one for the child and one for the caregiver. The intervention consists of 12 modules, delivered over a maximum of 14 weeks. The treatment includes psychoeducation about ASD, OCD, healthy habits, and how stress is a contributor to OCD symptoms. The rationale is that targeting and reducing stress will have a beneficial impact on anxiety, obsessions, and compulsions. The main goal of the treatment is to learn how to reduce stress, mainly by using relaxation techniques such as deep breathing, progressive muscle relaxation, and imagery (cognitive) relaxation. The modules also contain homework tasks that are meant to be completed between modules, mainly consisting of relaxation tasks. The version for parents contains psychoeducation, as well as strategies on how to assist their child in the different relaxation tasks.

Study Details

The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the effect durability of a therapist-guided, internet-delivered cognitive-behavior therapy intervention for obsessive-compulsive disorder (OCD) in children and adolescents with autism. A process evaluation of the treatment will also be conducted.

Key Dates

First listed
Sep 3, 2024
Start date
Nov 25, 2024
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Internet-delivered exposure and response prevention (I-ERP)
    A therapist-guided, internet-delivered exposure and response prevention (I-ERP) programme for children and adolescents with OCD and autism.
  • Active Comparator: Internet-delivered stress management (I-SM)
    A therapist-guided, internet-delivered stress management (I-SM) programme for children and adolescents with OCD and autism.

Primary Outcome Measure

Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) [ Time Frame: Baseline (week 0), post treatment (week 12), 3-months follow-up, 6-months follow up. ]

Central Contacts

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