The Family Check-Up in Autism Services

NCT05280613 | Completed

• 1 other identifier: FAIR Study
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Behavior Problem; Emotional Problem

Outcome Measures

Primary Outcomes (2)

• Change in Aberrant Behavior Checklist (ABC) - irritability subscale

  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)

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

  0, 3, 6 months

Secondary Outcomes (8)

• 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 Parenting Young Children (PARYC)

  0, 6 months

• Change in Parental Monitoring Scale

  0, 6 months

Study Arms (2)

Family Check-Up

EXPERIMENTAL

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.

Behavioral: Family Check-Up

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Family Check-Up BEHAVIORAL

See arm/group description

Family Check-Up

Treatment as Usual BEHAVIORAL

See arm/group description

Treatment as Usual

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (11)

• Dishion TJ, Mauricio AM. The Family Check-Up model as prevention and treatment of adolescent drug use: The intervention strategy, outcomes, and implementation model. In: Family-Based Prevention Programs for Children and Adolescents (pp. 98-122). London, UK: Psychology Press: 2015.

  BACKGROUND

• Dishion TJ, Stormshak EA, Kavanagh KA. Everyday parenting: A professional's guide to building family management skills. Champaign, IL: Research Press; 2012.

  BACKGROUND

• Aman MG, Singh NN, Stewart AW, Field CJ. Psychometric characteristics of the aberrant behavior checklist. Am J Ment Defic. 1985 Mar;89(5):492-502.

  PMID: 3158201 BACKGROUND

• Kaat AJ, Lecavalier L, Aman MG. Validity of the aberrant behavior checklist in children with autism spectrum disorder. J Autism Dev Disord. 2014 May;44(5):1103-16. doi: 10.1007/s10803-013-1970-0.

  PMID: 24165702 BACKGROUND

• Kohout FJ, Berkman LF, Evans DA, Cornoni-Huntley J. Two shorter forms of the CES-D (Center for Epidemiological Studies Depression) depression symptoms index. J Aging Health. 1993 May;5(2):179-93. doi: 10.1177/089826439300500202.

  PMID: 10125443 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Crnic KA, Greenberg MT. Minor parenting stresses with young children. Child Dev. 1990 Oct;61(5):1628-37. doi: 10.1111/j.1467-8624.1990.tb02889.x.

  PMID: 2245752 BACKGROUND

• McEachern AD, Dishion TJ, Weaver CM, Shaw DS, Wilson MN, Gardner F. Parenting Young Children (PARYC): Validation of a Self-Report Parenting Measure. J Child Fam Stud. 2012 Jun;21(3):498-511. doi: 10.1007/s10826-011-9503-y.

  PMID: 22876108 BACKGROUND

• Stattin H, Kerr M. Parental monitoring: a reinterpretation. Child Dev. 2000 Jul-Aug;71(4):1072-85. doi: 10.1111/1467-8624.00210.

  PMID: 11016567 BACKGROUND

• Gibaud-Wallston J, Wandersman LP. Parenting Sense of Competence Scale. Mahwah, NJ: Lawrence Erlbaum Associates; 1978.

  BACKGROUND

• Folkman S, Lazarus RS, Gruen RJ, DeLongis A. Appraisal, coping, health status, and psychological symptoms. J Pers Soc Psychol. 1986 Mar;50(3):571-9. doi: 10.1037//0022-3514.50.3.571.

  PMID: 3701593 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Child and Adolescent Psychiatrist; Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: March 15, 2022
• Study Start: October 17, 2022
• Primary Completion: August 31, 2024
• Study Completion: February 11, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)