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临床试验/NCT05981690
NCT05981690已完成不适用

Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD)

University of Reading2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)

研究概览

简要总结

This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT treatment for preadolescent children (aged 5 to 12 years old) with OCD.

Specifically, this study aims to:

  1. Examine outcomes for children who receive the therapist guided, parent-led, CBT treatment for preadolescent children with OCD.
  2. Examine parents' experiences and views about the acceptability of the treatment approach.

详细描述

This study adapted an existing therapist guided, parent-led CBT intervention for children with anxiety difficulties, to ensure suitability for preadolescent children with OCD.

This preliminary study aims to examine the outcomes from a therapist guided, parent-led, CBT treatment for preadolescent children (aged 5 to 12 years old) with OCD.

Specifically, this study aims to:

  1. Examine outcomes for children who receive the therapist guided, parent-led, CBT treatment for preadolescent children with OCD.
  2. Examine parents' experiences and views about the acceptability of the treatment approach.

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
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria:
  • Aged 5 to 12 years old (when parents/carers complete the baseline questionnaires).
  • Diagnosis of OCD (identified from the ADIS-P).
  • UK-resident. Parents
  • Inclusion criteria:
  • Parent/legal guardian of the child.
  • UK resident.

排除标准

  • Exclusion criteria:
  • Comorbid condition, which is likely to interfere with treatment delivery, for example:
  • Established Autism Spectrum Condition (ASC).
  • Suspected ASC (indicated by exceeding the threshold of 15 on the Social Communication Questionnaire and where a diagnosis of ASC has not been ruled out by a medical professional).
  • Profound learning difficulty (evidenced by attending a specialist school).
  • Risk and/or safeguarding concerns, which are paramount and would interfere with treatment delivery, for example:
  • Suicidal intent.
  • Recurrent or potentially life limiting self-harm.
  • Significant safeguarding concerns (i.e., if the child has a child protection plan and/or is on the child protection register, and/or the research team consider the child to be suffering, or likely to suffer, significant harm).
  • If children have been prescribed psychotropic medication, the dosage must have been stable for two months.
  • Children who are currently receiving other psychological support/interventions delivered by a mental health professional.
  • Exclusion criteria:
  • Significant intellectual impairment that is likely to interfere with treatment delivery.
  • Unable to access or understand written English language materials needed for the intervention.

结局指标

主要结局

Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS)

时间窗: Change from pre-baseline phase, within one-week post-treatment, one-month follow-up

Diagnostic interview. Higher scores indicate higher severity of OCD

次要结局

  • Anxiety Disorder Interview Schedule - Parent Report (ADIS-P)(Change from pre-baseline phase, within one-week post-treatment, one-month follow-up)
  • Children's Obsessional Compulsive Inventory - Revised - Parent Report (ChOCI-R-P)(Weekly during baseline and intervention phase; one month follow up)
  • Session Rating Scale- SRS(Weekly during intervention phase; one month follow-up)
  • Items assessing parent knowledge of OCD, how to help their child, and confidence to help child(Weekly during baseline and intervention phase; one month follow up)
  • Items assessing how much children have learned new information about their fears/ability to cope in feared situations(Weekly during intervention phase; one month follow up)
  • Family Accommodation Scale - FAS(Weekly during baseline and intervention phase; one month follow up)
  • Goal Based Outcomes - GBOs(Weekly during intervention phase; one month follow up)
  • Treatment acceptability questions(one month follow-up)

研究者

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

Kate Harvey

Professor Kate Harvey

University of Reading

研究点 (2)

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