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Completed

NCT Number: NCT05280613

The Family Check-Up in Autism Services

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Problem Child Development Disorders, Pervasive Emotional Problem Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Check-Up

Behavioral

See arm/group description

Treatment as Usual

Behavioral

See arm/group description

Primary outcomes

  1. Change in Aberrant Behavior Checklist (ABC) - irritability subscale

    Time frame: 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

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

    Time frame: 0, 3, 6 months

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

Secondary outcomes

  1. Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R)

    Time frame: 0, 3, 6 months

    The CESD-R is a 20 item measure of depression. Scores range from 0-80 with higher scores indicating worse depression.

  2. Change in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 0, 3, 6 months

    The GAD-7 is a brief measure of generalized anxiety. Scores range from 0-21 with higher scores indicating greater anxiety

  3. Change in Parenting Daily Hassles

    Time frame: 0, 3, 6 months

    The Parenting Daily Hassles is a measure of parenting stress. Scores range from 0 - 80 with higher scores indicating greater parenting stress.

  4. Change in Parenting Young Children (PARYC)

    Time frame: 0, 6 months

    This is a measure of important parenting skills such as positive behaviour support, limit setting, and proactive parenting. Scores range from 0 - 72, with higher scores indicating higher use of parenting skills

  5. Change in Parental Monitoring Scale

    Time frame: 0, 6 months

    This is a measure of monitoring, an important parenting skill. Scores range from 0-44 with higher scores indicating higher monitoring.

  6. Change in Parent Empowerment and Efficacy Measure (PEEM)

    Time frame: 0, 6 months

    This is a measure of parents' sense of control or capacity to manage the challenges of being a parent and provide a safe and supportive home environment. Scores range from 20-200 and higher scores indicate higher parent empowerment and efficacy.

  7. Change in Brief Coping Orientation to Problems Experienced (Brief COPE)

    Time frame: 0, 6 months

    This is a measure of coping strategies. Scores range from 28 - 112 with higher scores indicating higher usage of coping strategies.

  8. Clinical Global Impressions - Improvement (CGI-I)

    Time frame: 0, 3, 6 months

    The CGI-I measures the change in problem behaviours over time. Scores of 1-3 indicate improvement; a score of 4 indicates no change, and scores of 5-7 indicate worsening of behaviour.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 15, 2022
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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