Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
ID03495440

Families of Youth with Developmental Disabilities: a Theory-Based Intervention

Led by University of Notre Dame · Updated on 2024-11-15

150

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a preventive program designed to support families that include a child with intellectual and/or developmental disabilities (IDD). The study aims to reduce family stress and conflict, improve well-being and adjustment for parents and typically developing (TD) siblings, and enhance adaptive functioning for the child with IDD. This randomized, controlled trial uses a family-systems approach to test a psycho-educational and communication training program adapted from a previously validated intervention. Participants are randomly assigned to one of two groups: a treatment group receiving psychoeducation and communication coaching over four weeks, or a control group receiving self-study materials and regular contact with study personnel. The study involves families with a child with IDD and a TD sibling aged 11 to 17 years. The intervention is delivered either in center sessions or through at-home self-study resources. Families participate in a pre-test assessment followed by three post-test assessments over the course of one year, including 6-month and 1-year follow-ups. Researchers will assess changes in marital satisfaction, family functioning, sibling emotional security, adjustment, depressive symptoms, and adaptive functioning of the child with IDD. Data collection includes surveys, behavioral coding, and daily diaries to monitor family interactions and program effects.

CONDITIONS

Brief Title

Families of Youth with Developmental Disabilities: a Theory-Based Intervention

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Families must include mothers, fathers, a typically developing sibling aged 11 to 17 years, and a child with intellectual or developmental disability of any age
  • All participants must understand and respond to survey questions in English
  • Parents must be living together with both children in the home
  • The child with IDD must meet criteria for intellectual disability, autism spectrum disorder, or have a medically verified genetic developmental disability with cognitive or adaptive deficits
Not Eligible

You will not qualify if you...

  • Typically developing siblings with a score of 10 or higher on the SCQ-L and confirmed ASD diagnosis
  • Typically developing siblings with a WASI-II score of 75 or lower

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 4 weeks

Participants receive psycho-educational and communication coaching through center sessions or self-study resources paired with regular contact with study personnel.

Weekly visits for 4 weeks

Follow-up

Duration - 1 year

Participants complete assessments to evaluate changes in family relationships and individual well-being at 6 months and 1 year after treatment.

2 visits (at 6 months and 1 year post-treatment)

Trial Site Locations

Total: 2 locations

1

Wm. J. Shaw Center for Children and Families

Fort Wayne, Indiana, United States, 46814

Not Yet Recruiting

2

Wm. J. Shaw Center for Children and Families

South Bend, Indiana, United States, 46814

Actively Recruiting

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Research Team

E

Edward M Cummings, PhD

K

Kathleen N Bergman, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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