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临床试验/NCT05280613
NCT05280613已完成不适用

The Family Check-Up: Implementing a New Family-Centred Model Within Autism Services

McMaster University2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年10月17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
82
试验地点
2
主要终点
Change in Aberrant Behavior Checklist (ABC) - irritability subscale

研究概览

简要总结

Many children and youth with autism spectrum disorder have high levels of emotional and behavioural problems. Parents play a powerful role in supporting their children's well-being. Research also shows that certain factors (e.g., parent mental health, access to services) can affect autistic children's well-being in important ways. Despite this, autism services rarely ask about, or act upon, the factors that we know affect child and family well-being. We are addressing this problem by testing a program called the Family Check-Up within a large autism service. The Family Check-Up is a strengths-based, family-centred program aimed at improving child well-being by working with parents to identify their family's unique strengths and challenges, set goals for change, strengthen positive parenting, and connect to needed supports.

详细描述

Prevalence rates of emotional and behavior problems (EBP) in children and youth with autism spectrum disorder (ASD) are high (40-70%), and often cause severe and chronic impairment. Childhood EBP has been linked to ecological adversity (e.g., social isolation, parenting stress). Positive parenting practice can protect against adverse child outcomes such as poor self-regulation, chronic stress and EBP. Interventions aspiring to alleviate EBP in children with ASD need to involve caregivers in a collaborative, empowering and meaningful way.

In the current Ontario ASD services landscape, there are no evidence-based family-centered programs that adequately address these needs. The Family Check-Up (FCU) is a brief, ecologically sensitive, evidence-based, trans-diagnostic intervention that engages families in a process of enhancing positive parenting practices to reduce child EBP. It is unique in its multi-modal assessment of ecological risk and protective factors, strength-based motivational interviewing approach and health maintenance design, providing annual check-ups during key periods of development. It may be linked to an optional, tailored "Everyday Parenting Curriculum" (EPC). Studies have demonstrated sustained, reliable, and robust positive effects on child EBP, caregiver depression, and positive parenting practices in other populations at risk, but the FCU has not been evaluated in families of autistic children and youth. Thus, the objective is to evaluate FCU implementation in the Hamilton Health Sciences (HHS) Autism Program, with delivery by autism therapists, in order to demonstrate sustainable effectiveness within real-world settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Participants will know whether they have been randomized to receive the Family Check-Up or treatment as usual. Clinicians cannot be blinded because they will be providing the intervention. However, investigators and outcome assessors will be blinded to treatment status.

入排标准

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

入选标准

  • Child 6-17 years of age with a confirmed diagnosis of ASD
  • Enrollment in the Ontario Autism Program
  • Minimum developmental age of 2
  • Elevated emotional and behaviour problems
  • Residing with the same caregiver at least 5 days/week or every other week for the past 2 months and foreseeable future

排除标准

  • Parent with insufficient knowledge of English to complete assessments
  • Current enrollment in another intervention study
  • Active significant safeguarding concerns (e.g., child acute severe self-harm or aggression, acute parent or child suicidality)
  • Prior participation in the Family Check-Up

结局指标

主要结局

Change in Aberrant Behavior Checklist (ABC) - irritability subscale

时间窗: 0, 3, 6 months

The ABC was designed to measure psychiatric symptoms and behavioural disturbances. The irritability subscale is commonly used as an outcome in ASD research. Scores can range from 0 - 45, with higher scores indicating higher irritability

Change in Home Situation Questionnaire -ASD (HSQ-ASD)

时间窗: 0, 3, 6 months

The HSQ-ASD was designed to measure the severity of non-compliant behaviour of autistic children in common situations

次要结局

  • Change in Parenting Young Children (PARYC)(0, 6 months)
  • Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R)(0, 3, 6 months)
  • Change in Generalized Anxiety Disorder-7 (GAD-7)(0, 3, 6 months)
  • Change in Parenting Daily Hassles(0, 3, 6 months)
  • Change in Parental Monitoring Scale(0, 6 months)
  • Change in Parent Empowerment and Efficacy Measure (PEEM)(0, 6 months)
  • Change in Brief Coping Orientation to Problems Experienced (Brief COPE)(0, 6 months)
  • Clinical Global Impressions - Improvement (CGI-I)(0, 3, 6 months)

研究者

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

Teresa Bennett

Child and Adolescent Psychiatrist; Associate Professor

McMaster University

研究点 (2)

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