Family Check-Up for Autism

Overseen By Teresa Bennett, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Non-English, Other study, Safeguarding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the well-being of children and teens with autism spectrum disorder by involving their parents in the Family Check-Up program, a family-focused intervention. The program helps parents identify their family's strengths and challenges, set goals, and connect with helpful resources. Participants will either receive the Family Check-Up or continue with their usual treatment, with the option to try the program afterward. Families with children aged 6-17 who have autism, emotional and behavior issues, and live in Ontario may find this trial beneficial. As an unphased trial, the study offers families a unique opportunity to enhance their support network and improve their child's well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on family support and parenting strategies rather than medication changes.

What prior data suggests that the Family Check-Up program is safe for families?

Research has shown that the Family Check-Up program is safe and easy for families to join. Studies have found that this program can improve parenting skills and family management. No reports indicate negative effects from participation. The Family Check-Up supports parents and builds on family strengths without using medications or medical procedures, making it a low-risk choice for families seeking to enhance their children's well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Check-Up for Autism because it offers a personalized approach to enhancing family dynamics and parenting skills. Unlike typical treatments that mainly focus on the child, this method involves a comprehensive assessment of the family's environment and creates a tailored plan to boost positive parenting and family management. By engaging families directly and connecting them to specific services and support, the Family Check-Up aims to address the ecological factors affecting a child's behavior, which could lead to more effective and lasting improvements.

What evidence suggests that the Family Check-Up is effective for improving child well-being in autism?

Research has shown that the Family Check-Up program, which participants in this trial may receive, can assist with emotional and behavioral issues in children, including those with autism. One study found that more children showed improvement in behaviors like defiance and inattention after participating in the Family Check-Up. The program also helps parents enhance their skills and gain confidence in caring for their children. Parents reported better parenting practices and felt more capable of managing their child's needs. These improvements suggest the program could benefit families facing autism-related challenges. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 6-17 with autism spectrum disorder (ASD) who show high levels of emotional and behavioral problems. They must be enrolled in the Ontario Autism Program, live with a caregiver consistently, and have a developmental age of at least 2 years. Parents need to speak English well enough for assessments but can't join if they're in another study or have done the Family Check-Up before.

Inclusion Criteria

I have been living with my caregiver consistently for the past 2 months and will continue to do so.

Elevated emotional and behaviour problems

My child is at least 2 years old in terms of development.

Exclusion Criteria

Current enrollment in another intervention study

Active significant safeguarding concerns (e.g., child acute severe self-harm or aggression, acute parent or child suicidality)

Parent with insufficient knowledge of English to complete assessments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Family Check-Up Intervention

Families receive the Family Check-Up intervention, which includes assessing ecological risk and protective factors, engaging parents in a tailored plan, and connecting families to services.

6 months

Regular sessions with a clinician

Treatment as Usual

Families receive standard autism program services, including consultations, workshops, and support groups.

6 months

Follow-up

Participants are monitored for changes in parenting skills, child behavior, and parental mental health.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Check-Up

Trial Overview The trial is testing the 'Family Check-Up' program within an autism service setting. This program focuses on enhancing child well-being by empowering parents through identifying family strengths, goal-setting, positive parenting techniques, and connecting them to additional resources.

How Is the Trial Designed?

Group I: Family Check-Up Experimental Treatment 1 Intervention

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.

Group II: Treatment as Usual Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10826514/

The Family-Check-Up® Autism Implementation Research ... A study evaluating the effectiveness and implementation of a family-centered intervention within a Canadian autism service setting.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0885200624001364

Family Check-Up Online effects on parenting and ... The current study demonstrates the effectiveness of the FCU-O intervention for improving parent-reported parenting skills, parenting self-efficacy, and ...

3. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2787480

Effectiveness of Screening in Early Intervention Settings to ... In this difference-in-difference analysis, ASD screening in EI was associated with a 60% increase in ASD diagnoses compared with standard care.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38292388/

The Family-Check-Up® Autism Implementation Research ... Primary and secondary outcomes include child EBP, and caregiver well-being and parenting. (2) A mixed methods implementation study, to describe facilitators and ...

5. nature.com nature.com/articles/s41598-018-29550-z

Randomized effectiveness Trial of the Family Check-Up ... A significantly larger proportion of children in the FCU recovered at post-treatment with regard to opposition defiant behavior, inattention, ...

6. publications.aap.org publications.aap.org/pediatrics/article/155/4/e2024067947/201180/Family-Navigation-Programs-for-Children-With

Family Navigation Programs for Children With Autism ... This scoping review aimed to map the current evidence to describe the characteristics and synthesize the effectiveness of FN programs for children with ASD.

7. researchgate.net researchgate.net/publication/377453805_The_Family-Check-UpR_Autism_Implementation_Research_FAIR_Study_protocol_for_a_study_evaluating_the_effectiveness_and_implementation_of_a_family-centered_intervention_within_a_Canadian_autism_service_s

The Family-Check-Up® Autism Implementation Research ... Studies have demonstrated long-term positive child and caregiver outcomes in other populations, but the FCU® has not been evaluated in families ...

8. pm.amegroups.org pm.amegroups.org/article/view/4869/html

The effects of early autism intervention on parents and family ... Results revealed medium to large effects on parenting stress, depression and anxiety; however, authors note homogeneity of samples, overall ...