The Family Check-Up in Autism Services

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05280613
• Other study ID #: FAIR Study
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: McMaster University
• Contact: Teresa Bennett, MD, PhD
• Phone: 905-521-2100
• Email: bennetta[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Behavior Problem
• Emotional Problem
• Problem Behavior

Intervention

Behavioral:
• Family Check-Up
See arm/group description
• Treatment as Usual
See arm/group description

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View Citation

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. — View Citation

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.

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R)	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
Secondary	Change in Generalized Anxiety Disorder-7 (GAD-7)	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
Secondary	Change in Parenting Daily Hassles	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
Secondary	Change in Parenting Young Children (PARYC)	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
Secondary	Change in Parental Monitoring Scale	This is a measure of monitoring, an important parenting skill. Scores range from 0-44 with higher scores indicating higher monitoring.	0, 6 months
Secondary	Change in Parent Empowerment and Efficacy Measure (PEEM)	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
Secondary	Change in Brief Coping Orientation to Problems Experienced (Brief COPE)	This is a measure of coping strategies. Scores range from 28 - 112 with higher scores indicating higher usage of coping strategies.	0, 6 months
Secondary	Clinical Global Impressions - Improvement (CGI-I)	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