- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05280613
- Original Trial
The Family Check-Up in Autism Services
The Family Check-Up: Implementing a New Family-Centred Model Within Autism Services
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8S 4L8
- McMaster University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
|---|---|
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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.
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See arm/group description
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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.
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See arm/group description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Aberrant Behavior Checklist (ABC) - irritability subscale
Time Frame: 0, 3, 6 months
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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
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0, 3, 6 months
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Change in Home Situation Questionnaire -ASD (HSQ-ASD)
Time Frame: 0, 3, 6 months
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The HSQ-ASD was designed to measure the severity of non-compliant behaviour of autistic children in common situations
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0, 3, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R)
Time Frame: 0, 3, 6 months
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The CESD-R is a 20 item measure of depression.
Scores range from 0-80 with higher scores indicating worse depression.
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0, 3, 6 months
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Change in Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 0, 3, 6 months
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The GAD-7 is a brief measure of generalized anxiety.
Scores range from 0-21 with higher scores indicating greater anxiety
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0, 3, 6 months
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Change in Parenting Daily Hassles
Time Frame: 0, 3, 6 months
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The Parenting Daily Hassles is a measure of parenting stress.
Scores range from 0 - 80 with higher scores indicating greater parenting stress.
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0, 3, 6 months
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Change in Parenting Young Children (PARYC)
Time Frame: 0, 6 months
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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
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0, 6 months
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Change in Parental Monitoring Scale
Time Frame: 0, 6 months
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This is a measure of monitoring, an important parenting skill.
Scores range from 0-44 with higher scores indicating higher monitoring.
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0, 6 months
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Change in Parent Empowerment and Efficacy Measure (PEEM)
Time Frame: 0, 6 months
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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.
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0, 6 months
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Change in Brief Coping Orientation to Problems Experienced (Brief COPE)
Time Frame: 0, 6 months
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This is a measure of coping strategies.
Scores range from 28 - 112 with higher scores indicating higher usage of coping strategies.
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0, 6 months
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Clinical Global Impressions - Improvement (CGI-I)
Time Frame: 0, 3, 6 months
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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.
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0, 3, 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Stattin H, Kerr M. Parental monitoring: a reinterpretation. Child Dev. 2000 Jul-Aug;71(4):1072-85. doi: 10.1111/1467-8624.00210.
- 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.
- 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.
- 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.
- Dishion TJ, Stormshak EA, Kavanagh KA. Everyday parenting: A professional's guide to building family management skills. Champaign, IL: Research Press; 2012.
- 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.
- Gibaud-Wallston J, Wandersman LP. Parenting Sense of Competence Scale. Mahwah, NJ: Lawrence Erlbaum Associates; 1978.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAIR Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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