Clinical trial NCT05280613: The Family Check-Up in Autism Services
Official title: The Family Check-Up: Implementing a New Family-Centred Model Within Autism Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Behavior Problem
Emotional Problem
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2022-03-15
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An intention-to-treat, parallel-arm randomized controlled trial of N=80 autistic children/youth (ages 6-17 years) with ASD and high levels of EBP and their caregivers.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Aberrant Behavior Checklist (ABC) - irritability subscale
timeFrame: 0, 3, 6 months
measure: Change in Home Situation Questionnaire -ASD (HSQ-ASD)
timeFrame: 0, 3, 6 months
Secondary outcomes:
measure: Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R)
timeFrame: 0, 3, 6 months
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 0, 3, 6 months
measure: Change in Parenting Daily Hassles
timeFrame: 0, 3, 6 months
measure: Change in Parenting Young Children (PARYC)
timeFrame: 0, 6 months
measure: Change in Parental Monitoring Scale
timeFrame: 0, 6 months
measure: Change in Parent Empowerment and Efficacy Measure (PEEM)
timeFrame: 0, 6 months
measure: Change in Brief Coping Orientation to Problems Experienced (Brief COPE)
timeFrame: 0, 6 months
measure: Clinical Global Impressions - Improvement (CGI-I)
timeFrame: 0, 3, 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
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