An eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Feasibility of a Therapist and Parent Guided eHealth Intervention for Obsessive Compulsive Disorder in Youth With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473080
• Other study ID #: BIP ASD/OCD pilot
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: February 15, 2021

Study information

• Verified date: July 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Disease
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Internet CBT
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.

Locations

Country	Name	City	State
Sweden	BUP OCD and Related Disorders	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Obsessive-compulsive inventory - child version	Child-rating of OCD symptoms. The total score range is 0-42, a higher score indicates more OCD-symptoms.	Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary	Autism spectrum quotient (AQ-10)	Parent-rated, brief screeing for symtoms relating to autism spectrum disorder. Total score ranges from 0-10, a higher score indicating more symtoms.	Baseline
Secondary	Education, work and social adjustment scale - child and parent version	Self-rated and parent-rated. Ranges from 0 to 40 points, a higher score indicating more problems. Measures how much the psychiatric problems affect daily life in different areas.	Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary	Family accommodation scale for obsessive-compulsive disorder	Parent-rated scale, total score ranges from 0 to 76, a higher score indicates more family accommodation to the child's OCD.	Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary	Mood and Feeling Questionnaire - child and parent version	Self-rated and parent-rated. Measures depressive symptoms in the child. Total score ranges from 0 to 26, a higher score indicates more depressive symptoms.	Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary	Children's Obsessional Compulsive Inventory Revised - parent rated (ChOCI-R-P)	Parent-rated. Consists of 4 Subscales. Obsessive symptoms, Compulsive symtoms, Obsessive impairment and Compulsive impairment. The symptom subscales range from 10 to 30 points, a higher score indicating more symptomology. These subscales are added to get a total score for OCD-symptoms. The score of each impairment subscales ranges from 0 to 24, a higher score indicating more impairment. The score of the impairment subscales are added to get a total score of impairment. The symptom subscales will only be administered at baseline. The impairment subscales will be administered at all assessment points.	Baseline, weekly during treatment, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary	Mini International Neuropsychiatric Interview for Children and Adolescents	Clinician-rated, a semi-structured interview to asses psychiatric problems in children. Results will be presented as co-morbid psychiatric diagnoses.	Baseline
Secondary	Children's global assessment scale	Clinician-rated, measures the childs global psychiatric functioning. Total score ranges from 0-100, a lower score indicates lower functioning.	Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary	Children's Assessment Scale for Developmental Disabilities	Clinician-rated. measures the childs global functioning with respect to developmental disabilities. Total score ranges from 0 to 100, a lower score indicates lower functioning.	Baseline
Secondary	Clinical global impression - severity	Clinician-rated level of psychiatric severity, the score ranges from 1 to 7, a lower score indicates less severity. In this study the measure will only refer to level of OCD.	Baseline, 16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary	Clinical global impression - improvement	Clinician-rated level of psychiatric improvement, the score ranges from 1 to 7, a lower score indicates more improvement. In this study the measure will only refer to level of OCD.	16 weeks (= post treatment), 3 months after post treatment, 6 months after post treatment, 12 months after post treatment
Secondary	internet intervention Patient Adherence Scale	Clinician-rated, measures the patients adherence to treatment. The scale consist of 5 items measuring 1. If the patient is in phase with treatment, 2, level of engagement in treatment 3, level of communication with the clinician, 4 motivation to change 5, frequency of log-ins to the internet-treatment. Total score ranges from 0 to 20, a higher score indicates more adherence to the treatment.	8 weeks, 16 weeks
Secondary	Client Satisfaction Questionnaire (CSQ-8)	Self-rated and parent-rated. Measures level of satisfaction with the treatment. Total score ranges from 8 to 32, higher level indicates higher satisfaction.	16 weeks
Secondary	Parent strategies	A parent-rated questionnaire consisting of 4 items measuring the parents 1, participation in treatment, 2, cooperation with the child during treatment, 3, autonomus support in treatment and 4, directiveness in treatment. The questions are qualitative and results will be presented on an item level	Post-treatment
Secondary	Patient EX/RP Adherence Scale	Self-rated questionnaire. Consist of 3 items: 1, percentage of attempted exposure exercises, 2, how well exposures were performed and 3, percentatge of respons-prevention during the last week. The answers will be presented on an item level.	Weekly for 16 weeks (during treatment)
Secondary	Drop-out rate from treatment	Percentage of patients that drop out from ICBT	at week 16
Secondary	Completed treatment modules	Number of completed treatment modules	week 16