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临床试验/NCT02660099
NCT02660099已完成不适用

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

Karolinska Institutet3 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
3
主要终点
Obsessional Compulsive Inventory - Child version, OCI-CV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Obsessional Compulsive Inventory - Child version, OCI-CV

时间窗: Change from baseline to 12 weeks

Self-rated OCD symptom levels

次要结局

  • Children's Yale Brown Obsessive Compulsive Scale(Change from baseline to 12 weeks)
  • Mini International Neuropsychiatric Interview for Children and Adolescents, MINI-KID(Baseline)
  • Clinical Global Impression - Severity, CGI-S(Change from baseline to 12 weeks)
  • Clinical Global Impression - Improvement, CGI-I(Post treatment(12 weeks))
  • Children's Global Assessment Scale, CGAS(Change from baseline to 12 weeks)
  • Children´s Depression Inventory - Short version(Change from baseline to 12 weeks)
  • Strength and difficulties, SDQ(Change from baseline to 12 weeks)
  • Family Accommodation Scale, Parent-Report, FAS-PR(Change from baseline to 12 weeks)
  • Patient ICBT Adherence Rating, PIAR(after 6 weeks and at post treatment(12 weeks))
  • Education, Work and Social Adjustment Scale - child and parent version, EWSAS(Change from baseline to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Serlachius

Research director

Karolinska Institutet

研究点 (3)

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