The Family Check-Up in Autism Services

May 5, 2025 updated by: Teresa Bennett, McMaster University

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family Check-Up
Families randomized to the Family Check-Up arm will be connected with a clinician who will provide the Family Check-Up. The Family Check-Up® (FCU) is an ecologically sensitive, evidence-based intervention that was developed to decrease childhood EBP by 1) assessing known ecological (child, family and contextual) risk and protective factors; 2) engaging parents in a tailored plan to enhance positive parenting and family management skills; and 3) connecting families to a tailored suite of child and family services and supports. Services may include an evidence-based suite of parenting sessions ("Everyday Parenting Curriculum [EPC]") created by FCU developers for direct tailoring to the FCU feedback session.
See arm/group description
Active Comparator: Treatment as Usual
Treatment as Usual participants will be connected to a Family Service Coordinator within the Autism Program, who can direct the family to appropriate services and resources. Services may include consultation on child behaviours, workshops on various topics, parenting programs, Applied Behaviour Analysis, support groups, and group recreational programs. Families in the treatment as usual arm will be offered the Family Check-Up upon completion of the study.
See arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 3, 6 months
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
0, 3, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 3, 6 months
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
0, 3, 6 months
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.
0, 3, 6 months
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
0, 6 months
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.
0, 6 months
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.
0, 6 months
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.
0, 6 months
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.
0, 3, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

February 11, 2025

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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