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Family Check-Up for Autism

N/A

Recruiting

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Residing with the same caregiver at least 5 days/week or every other week for the past 2 months and foreseeable future

Minimum developmental age of 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 3, 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the Family Check-Up can improve child well-being for families who receive it as part of their child's usual care within an autism service.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves counseling and support services rather than medication, traditional side effects are not expected. However, participants may experience varying degrees of emotional discomfort when discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am a child aged 6-17 with a confirmed autism diagnosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 3, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 3, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Aberrant Behavior Checklist (ABC) - irritability subscale

Change in Home Situation Questionnaire -ASD (HSQ-ASD)

Secondary study objectives

Change in Brief Coping Orientation to Problems Experienced (Brief COPE)

Change in Center for Epidemiological Studies Depression Scale - Revised (CESD-R)

Change in Generalized Anxiety Disorder-7 (GAD-7)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Family Check-UpExperimental Treatment1 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 UsualActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Family Check-Up

2021

N/A

~2480

0 / 3Eligibility criteria met