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Completed

NCT Number: NCT02660099

Internet Delivered CBT for OCD in Adolescents With ASD - A Clinical Case Series

The aim of this study is to test the feasibility and acceptability of an internet-delivered cognitive behavior therapy (ICBT) intervention originally developed for neurotypical adolescents with obsessive compulsive disorder (OCD) in adolescents with OCD and autism spectrum disorder (ASD). This feasibility study will inform us how to adapt the original intervention to the specific needs of patients with ASD.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Stockholm, Sweden

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About this study

To evaluate the effectiveness of ICBT for OCD in adolescents with ASD, this study will use a single case experimental design with weekly measures during two phases: A-B. The A-phase will consist of baseline measures at least three weeks prior to treatment. The B-phase will consist of the 12 weeks ICBT-program as well as one measure post-treatment. Single case descriptions of each participant will be presented. Weekly measures on the Obsessional Compulsive Inventory - Child version (OCI-CV) will be analyzed through visual inspection of each participants graph and through computation of Percentage of Non-overlapping Data (PND). PND is a frequently used effect measure in SCED and reflects how large percentage of the measurements during the treatment-phase that do not overlap with any of the measurements during the base-line phase.

To assess the feasibility and comprehension of the ICBT treatment semi-structured interviews (face-to-face or telephone) will be conducted with participants and parents weekly during the four first weeks of ICBT and semi-weekly during the rest of the treatment. Detailed notes will be taken during each interview and will serve as content material for a thematic analysis trying to determine possible accommodations to the ICBT protocol to better suit patients with ASD.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a diagnosis of OCD as defined by DSM-5 [40]
  • a diagnosis of autism defined by DSM-5
  • a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS [14]
  • age between 12 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

  • psychosis or bipolar disorder, severe eating disorder
  • 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 another anxiety disorder

Treatment and study plan

Internet-delivered Cognitive Behavior Therapy

Behavioral

The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet platform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks. Both parents and adolescents are involved in treatment. Parents will also receive three lectures on 1, Autism spectrum disorder, 2, CBT and functional analysis and 3, Parental strategies

Primary outcomes

  1. Obsessional Compulsive Inventory - Child version, OCI-CV

    Time frame: Change from baseline to 12 weeks

    Self-rated OCD symptom levels

Secondary outcomes

  1. Children's Yale Brown Obsessive Compulsive Scale

    Time frame: Change from baseline to 12 weeks

    Clinician-rated OCD symptom levels

  2. Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID

    Time frame: Baseline

    psychiatric screening of comorbidity

  3. Clinical Global Impression - Severity, CGI-S

    Time frame: Change from baseline to 12 weeks

    Global symptom levels

  4. Clinical Global Impression - Improvement, CGI-I

    Time frame: Post treatment(12 weeks)

    Global symptom improvement

  5. Children's Global Assessment Scale, CGAS

    Time frame: Change from baseline to 12 weeks

    Global level of functioning

  6. Children´s Depression Inventory - Short version

    Time frame: Change from baseline to 12 weeks

    Symptom level of depressive mood

  7. Strength and difficulties, SDQ

    Time frame: Change from baseline to 12 weeks

    General psychopathology

  8. Family Accommodation Scale, Parent-Report, FAS-PR

    Time frame: Change from baseline to 12 weeks

    Parental accommodation to OCD symptoms

  9. Patient ICBT Adherence Rating, PIAR

    Time frame: after 6 weeks and at post treatment(12 weeks)

    Patient Adherence to internet delivered CBT

  10. Education, Work and Social Adjustment Scale - child and parent version, EWSAS

    Time frame: Change from baseline to 12 weeks

    Global functioning

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Internet Delivered Cognitive Behavior Therapy for Obsessive-compulsive Disorder in Adolescents With Autism Spectrum Disorder - A Clinical Case Series

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 21, 2016
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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