Autism Spectrum DisorderNCT05280613
The Family Check-Up in Autism Services
A study testing Family Check-Up and Treatment as Usual in people with Autism Spectrum Disorder and Behavior Problem, run by McMaster University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, Behavior Problem, Emotional Problem
- What is being tested?
- Family Check-Up and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2022to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Family Check-Up: Implementing a New Family-Centred Model Within Autism Services
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.
Read the 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.
- Being tested
- Family Check-Up, Treatment as Usual
- Medical subject headings
- Autism Spectrum Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check-UpBehavioural
See arm/group description
Treatment as UsualBehavioural
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 0, 3, 6 months
Secondary outcomes (8)
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.
Measured: 0, 3, 6 months
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
Measured: 0, 3, 6 months
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.
Measured: 0, 3, 6 months
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
Measured: 0, 6 months
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.
Measured: 0, 6 months
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.
Measured: 0, 6 months
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.
Measured: 0, 6 months
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.
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start17 Oct 2022
- Primary completion31 Aug 2024
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Teresa Bennett, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280613
- Sponsor's protocol ID
- FAIR Study
- Status last verified
- May 2025
- First submitted
- 21 Dec 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 3158201Kaat 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.
PubMed 24165702Kohout 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.
PubMed 10125443Spitzer 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.
PubMed 16717171Crnic 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.
PubMed 2245752McEachern 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.
PubMed 22876108Stattin H, Kerr M. Parental monitoring: a reinterpretation. Child Dev. 2000 Jul-Aug;71(4):1072-85. doi: 10.1111/1467-8624.00210.
PubMed 11016567Gibaud-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.
PubMed 3701593
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Family Check-Up: Implementing a New Family-Centred Model Within Autism Services
- ClinicalTrials.gov ID
- NCT05280613
- Acronym / sponsor ID
- FAIR Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family Check-Up | Experimental | Behavioral: Family Check-UpFamilies 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. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Check-UpSee arm/group description | Behavioural | Family Check-Up |
| Treatment as UsualSee arm/group description | Behavioural | Treatment as Usual |
Primary outcome
Change in Aberrant Behavior Checklist (ABC) - irritability subscale
Time frame: 0, 3, 6 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
Change in Home Situation Questionnaire -ASD (HSQ-ASD)
Time frame: 0, 3, 6 months
The HSQ-ASD was designed to measure the severity of non-compliant behaviour of autistic children in common situations
8 secondary outcomes
Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R)
Time frame: 0, 3, 6 months
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 0, 3, 6 months
Change in Parenting Daily Hassles
Time frame: 0, 3, 6 months
Change in Parenting Young Children (PARYC)
Time frame: 0, 6 months
Change in Parental Monitoring Scale
Time frame: 0, 6 months
Change in Parent Empowerment and Efficacy Measure (PEEM)
Time frame: 0, 6 months
Change in Brief Coping Orientation to Problems Experienced (Brief COPE)
Time frame: 0, 6 months
Clinical Global Impressions - Improvement (CGI-I)
Time frame: 0, 3, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- BackgroundDishion 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.
- BackgroundDishion TJ, Stormshak EA, Kavanagh KA. Everyday parenting: A professional's guide to building family management skills. Champaign, IL: Research Press; 2012.
- Results publication: PubMed 3158201Aman MG, Singh NN, Stewart AW, Field CJ. Psychometric characteristics of the aberrant behavior checklist. Am J Ment Defic. 1985 Mar;89(5):492-502.
- Results publication: PubMed 24165702Kaat 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.
- Results publication: PubMed 10125443Kohout 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.
- Results publication: PubMed 16717171Spitzer 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.
- Results publication: PubMed 2245752Crnic 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.
- Results publication: PubMed 22876108McEachern 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.
- Results publication: PubMed 11016567Stattin H, Kerr M. Parental monitoring: a reinterpretation. Child Dev. 2000 Jul-Aug;71(4):1072-85. doi: 10.1111/1467-8624.00210.
- Results publicationGibaud-Wallston J, Wandersman LP. Parenting Sense of Competence Scale. Mahwah, NJ: Lawrence Erlbaum Associates; 1978.
- Results publication: PubMed 3701593Folkman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check-Up and Treatment as Usual in people with Autism Spectrum Disorder and Behavior Problem, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aberrant Behavior Checklist (ABC) - irritability subscale (time frame: 0, 3, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280613, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.