The Family Check-Up in Autism Services

NCT ID: NCT05280613

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2025-02-11

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder Behavior Problem Emotional Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Family Check-Up

Intervention Type BEHAVIORAL

See arm/group description

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.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

See arm/group description

Interventions

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Family Check-Up

See arm/group description

Intervention Type BEHAVIORAL

Treatment as Usual

See arm/group description

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Teresa Bennett

Child and Adolescent Psychiatrist; Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 3158201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24165702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10125443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2245752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22876108 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11016567 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 3701593 (View on PubMed)

Other Identifiers

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FAIR Study

Identifier Type: -

Identifier Source: org_study_id

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