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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Aberrant Behavior Checklist (ABC) - irritability subscale

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

Secondary outcome measures

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

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

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,806 Total Patients Enrolled

7 Trials studying Autism Spectrum Disorder

533 Patients Enrolled for Autism Spectrum Disorder

Hamilton Health Sciences CorporationOTHER

368 Previous Clinical Trials

300,921 Total Patients Enrolled

1 Trials studying Autism Spectrum Disorder

52 Patients Enrolled for Autism Spectrum Disorder

Media Library

Family Check-Up Clinical Trial Eligibility Overview. Trial Name: NCT05280613 — N/A

Autism Spectrum Disorder Research Study Groups: Family Check-Up, Treatment as Usual

Autism Spectrum Disorder Clinical Trial 2023: Family Check-Up Highlights & Side Effects. Trial Name: NCT05280613 — N/A

Family Check-Up 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280613 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What characteristics make someone a valid participant in this research trial?

"Eligibility for this clinical trial is restricted to individuals living with Autism Spectrum Disorder aged 6-17. In total, 80 patients are required to join the experiment."

Answered by AI

How many participants have been accepted to partake in this trial?

"That is correct. According to information on clinicaltrials.gov, this trial was originally posted on October 1st 2022 and has recently been updated as of November 10th 2022. Currently, 80 participants are being sought at a single medical location."

Answered by AI

What primary goals are being sought in this clinical experiment?

"To assess the efficacy of this trial, researchers will be tracking a primary outcome - Change in Aberrant Behavior Checklist (ABC) - irritability subscale. Other secondary outcomes include Change in Parenting Young Children (PARYC), Generalized Anxiety Disorder-7 (GAD-7), and Parenting Daily Hassles all scored on respective scales ranging from 0 to 80 or above."

Answered by AI

Are volunteers currently being considered for this research?

"Data hosted on clinicaltrials.gov indicates recruitment is underway for this medical experiment, with the original posting of October 1st 2022 and a subsequent update occurring 10 days later."

Answered by AI