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临床试验/NCT04714606
NCT04714606已完成不适用

Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD

University of Surrey2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年12月14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
12
试验地点
2
主要终点
Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores

研究概览

简要总结

A feasibility controlled trial of an eight-session group intervention for siblings of children who have an Autism Spectrum Disorder (ASD).

Children will be recruited from a multi-academy trust of nine schools. Due to the on-going impact of COVID-19 restrictions, children will be allocated to the intervention condition (eight session support group) if they are physically attending school and to the control condition (receipt of a booklet) if they remain at home. Pre and post outcome measures will be completed by children and their parents in both research arms.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 7-11 years old.
  • Must have a sibling who has a formal diagnosis of ASD.
  • Must be competent in the English language.
  • Must be in mainstream education.
  • Must be willing and able to engage in an eight-session group intervention (including being accompanied to and from the group by their parents/carers).
  • Must be registered with a GP and parental consent gained to inform the GP that the sibling is attending the group.

排除标准

  • If the sibling has a diagnosis of ASD themselves.
  • If there are any clear risk concerns (e.g. any thought or intent to harm self or others, involvement in court proceedings or with the criminal justice system).
  • If the sibling is currently receiving any other psychological treatment.
  • If the sibling has a learning disability or difficulty that will make it hard to access the group content and/or capacity to provide informed consent.

结局指标

主要结局

Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores

时间窗: Pre (Week 1) and post (Week 6) intervention

Questionnaire used to measure effectiveness pre and post intervention or control condition. Lower scores indicate better outcome.

Change in Paediatric Quality of Life Inventory (PedsQL V4.0; Varni, Seid & Kurtin, 2001) scores

时间窗: Pre (Week 1) and post (Week 6) intervention

Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.

Change in Knowledge of Autism Questionnaire (KAS; Ross & Cuskelly, 2006) scores

时间窗: Pre (Week 1) and post (Week 6) intervention

Questionnaire used to measure knowledge of autism pre and post intervention or control condition. Higher scores indicate better outcome.

Change in Goal Based Outcomes (GBOs, Law & Jacob, 2015) scores Goal Based Outcomes (GBOs, Law & Jacob, 2015)

时间窗: Pre (Week 1) and post (Week 6) intervention

Questionnaire used to measure effectiveness pre and post intervention or control condition. Higher scores indicate better outcome.

次要结局

  • Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002)(Post intervention (6 weeks after Time 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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