NCT03473080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

March 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

2.9 years

First QC Date

February 16, 2018

Last Update Submit

July 2, 2021

Conditions

Keywords

OCDASDObsessive Compulsive DisorderAutism Spectrum DisorderICBTeHealthInternetCBTPediatricAdolescentsChildrenInternet-delivered

Outcome Measures

Primary Outcomes (1)

  • Children's Yale-Brown Obsessive Compulsive Scale

    Changein obsessions and compulsions will be measured as the total score on the scale.. Total score ranges from 0 to 40 points, a higher score indicates more severe OCD. The scale is rated by a clinician.

    Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment

Secondary Outcomes (17)

  • Obsessive-compulsive inventory - child version

    Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment

  • Autism spectrum quotient (AQ-10)

    Baseline

  • Education, work and social adjustment scale - child and parent version

    Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment

  • Family accommodation scale for obsessive-compulsive disorder

    Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment

  • Mood and Feeling Questionnaire - child and parent version

    Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment

  • +12 more secondary outcomes

Study Arms (1)

Internet CBT

OTHER

Participants and their parents receive 16 weeks of internet-delivered cognitive behavior therapy (CBT) with psychologist support.

Behavioral: Internet CBT

Interventions

Internet CBTBEHAVIORAL

The treatment consists of a standard cognitive behavior therapy for OCD with additional treatment components to make the treatment better suited for children and adolescents with Autism Spectrum Disorder.

Also known as: ICBT, Internet-delivered Cognitive Behavior Therapy
Internet CBT

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BUP OCD and Related Disorders

Stockholm, 11330, Sweden

Location

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersChild Development Disorders, PervasiveNeurodevelopmental Disorders

Study Officials

  • Fabian Lenhard, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Principal Investigator

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 22, 2018

Study Start

March 9, 2018

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

July 6, 2021

Record last verified: 2021-07

Locations