The Family Check-Up in Autism Services

McMaster University (Other)
Overall Status
Not yet recruiting ID
Hamilton Health Sciences Corporation (Other)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family Check-Up
  • Behavioral: Treatment as Usual

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 Design

Study Type:
Anticipated Enrollment :
80 participants
Intervention Model:
Parallel Assignment
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.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.
Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Official Title:
The Family Check-Up: Implementing a New Family-Centred Model Within Autism Services
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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-UpĀ® (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.

Behavioral: Family Check-Up
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.

Behavioral: Treatment as Usual
See arm/group description

Outcome Measures

Primary Outcome Measures

  1. Change in Aberrant Behavior Checklist (ABC) - irritability subscale [0, 3, 6, 9, 12 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. Clinical Global Impressions - Improvement (CGI-I) [0, 6, 12 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.

Secondary Outcome Measures

  1. Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R) [0, 3, 6, 9, 12 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) [0, 3, 6, 9, 12 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 [0, 3, 6, 9, 12 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) [0, 6, 12 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 [0, 6, 12 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) [0, 6, 12 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) [0, 6, 12 months]

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

Eligibility Criteria


Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 McMaster University Hamilton Ontario Canada L8S 4L8

Sponsors and Collaborators

  • McMaster University
  • Hamilton Health Sciences Corporation


None specified.

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Teresa Bennett, Child and Adolescent Psychiatrist; Associate Professor, McMaster University Identifier:
Other Study ID Numbers:
First Posted:
Mar 15, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022