Family Program for Developmental Disabilities

Recruiting at 1 trial location

Overseen By Kathleen N Bergman, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Notre Dame

Disqualifiers: ASD diagnosis, WASI-II score 75 or lower

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

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a program that helps families with a child who has an intellectual or developmental disability improve communication and reduce stress. The program provides education and coaching to make family life better. It aims to support all family members by teaching them new ways to understand each other and solve problems together.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Theory-Based Intervention in the Family Program for Developmental Disabilities?

Research shows that a comprehensive, ecological approach to behavioral family intervention can lead to lasting improvements in child behavior and family routines. This approach, which involves parents actively participating in the intervention, has been effective in reducing problem behaviors and enhancing family interactions. ^{1 2 3 4 5}

Is the Family Program for Developmental Disabilities safe for participants?

The SAFE PLACE program, a similar multi-disciplinary intervention, was found to be safe and acceptable for children with complex trauma and sensory processing disorder, with high caregiver satisfaction. This suggests that similar programs may also be safe for participants. ^{6 7 8 9 10}

How does the Theory-Based Intervention treatment differ from other treatments for developmental disabilities?

The Theory-Based Intervention is unique because it focuses on a family-centered approach, integrating the needs and priorities of both the child and the family. It uses a comprehensive framework that coordinates children's developmental goals with family priorities, emphasizing relationships, comprehensiveness, and continuity, which is different from other treatments that may not consider the family's role as extensively. ^{11 12 13 14 15}

Research Team

Edward M Cummings, PhD

Principal Investigator

University of Notre Dame

Eligibility Criteria

This trial is for families with a child who has an intellectual or developmental disability (IDD). Parents must live together and have both the child with IDD and a typically developing sibling aged 11-17 at home. All participants should speak English. The child with IDD should meet specific criteria for intellectual disability, autism spectrum disorder, or have a genetic condition associated with developmental disabilities.

Inclusion Criteria

Parents must be cohabitating, with both participating children living in their home.

Participants must be able to understand and respond to survey questions in English

Participants in all conditions will include mothers, fathers, TD siblings between 11 and 17 years old, and individuals with IDD of any age.

Exclusion Criteria

Siblings who are not diagnosed with ASD and have an IQ score above 75 will be included.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-test Assessment

Participants undergo initial assessments before the intervention begins

1 week

1 visit (in-person)

Treatment

Participants receive psychoeducation and communication coaching over a four-week period or self-study materials

4 weeks

4 visits (in-person) for treatment group

Post-test Assessment

Participants undergo assessments immediately after the intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in family interactions and individual well-being

1 year

3 visits (in-person) at 6 months and 1 year

Treatment Details

Interventions

• Theory-Based Intervention

Trial Overview The study tests a program aimed to help these families by providing psychoeducation and communication coaching over four weeks versus self-study materials. Families are randomly placed into either the treatment group or control group, followed by assessments before and after the intervention.

Participant Groups

Group I: Center Sessions Experimental Treatment 1 Intervention

Treatment condition in which participants receive psychoeducation and communication coaching.

Group II: At-home Active Control 1 Intervention

Active, self-study control condition in which participants receive regular communication with study personnel and self-study materials to review on their own.

Who Is Running the Clinical Trial?

University of Notre Dame

Lead Sponsor

Trials

36

Recruited

60,000+

Findings from Research

A study involving 13 families showed that parent training in the Naturalistic Developmental Behavioral Intervention, Project ImPACT, is feasible and positively received in community settings.

Parents reported finding value in their involvement in the intervention, perceiving benefits for their children, which highlights the importance of parent engagement in early autism interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent perceptions of an adapted evidence-based practice for toddlers with autism in a community setting. Stahmer, AC., Brookman-Frazee, L., Rieth, SR., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Embedding comprehensive behavioral support in family ecology: an experimental, single-case analysis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Working with families: an intervention model for rehabilitation nurses. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Empowerment in parents of school-aged children with and without developmental disabilities. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Exploring contextual adaptations in caregiver interventions for families raising children with developmental disabilities. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Transforming Parent-Child Interaction in Family Routines: Longitudinal Analysis with Families of Children with Developmental Disabilities. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safe Place: Clinical Utility and Feasibility of a Multi-Disciplinary Intervention for Children with Sensory Processing Disorder and Complex Trauma - a Feasibility Study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Parent perceptions of an adapted evidence-based practice for toddlers with autism in a community setting. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Safety Awareness Group Program for Adults With Intellectual Disability. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Distance-Based Collaborations for Assessing and Treating Challenging Behavior. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A Review of Intervention Programs to Prevent and Treat Behavioral Problems in Young Children with Developmental Disabilities. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Applying the Developmental Systems Approach to Inclusive Community-Based Early Intervention Programs: Process and Practice. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Family-centered practices in home-based support for families with children with an intellectual disability: Judgments of parents and professionals. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The porridge-like framework: A multidimensional guidance to support parents of children with developmental disabilities. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

A community residence for severely disturbed adolescents: a cognitive-behavioral approach. [2004]

15. United States pubmed.ncbi.nlm.nih.gov

An outpatient treatment program for young children with pervasive developmental disorder. [2018]