150 Participants Needed

Family Program for Developmental Disabilities

Recruiting at 1 trial location
EM
KN
Overseen ByKathleen N Bergman, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Notre Dame
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support families with a child who has an intellectual or developmental disability by testing a new program called the Theory-Based Intervention. Some families will receive psychoeducation and coaching, while others will use self-study materials. The program is designed to help families improve communication and understanding. Families with parents living together, a child with a disability, and a typically developing sibling aged 11-17 are well-suited for this trial. As an unphased trial, this study offers families a unique opportunity to contribute to innovative research that could enhance family dynamics and support systems.

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 prior data suggests that this intervention program is safe for families?

Research has shown that programs like the Family Program for Developmental Disabilities are generally safe. Many studies have found these programs to be well-received by participants. For example, early programs for children with developmental challenges often result in better outcomes without major safety issues.

Additionally, a study on behavior assessment and intervention found it effective in teaching and managing safety practices. This suggests that the educational and communication components of the program typically do not cause problems.

Overall, evidence indicates that these types of programs are safe, with no major concerns reported in similar studies.12345

Why are researchers excited about this trial?

Researchers are excited about the Family Program for Developmental Disabilities because it explores innovative ways to support families. This program differs from traditional therapies by offering two distinct approaches: at-home self-study and center-based sessions. The at-home option provides families with regular communication and materials to learn at their own pace, promoting flexibility and empowerment. In contrast, the center sessions offer direct psychoeducation and communication coaching, aiming to enhance interpersonal skills and understanding. These options provide a tailored experience, potentially leading to more effective and personalized support for families dealing with developmental disabilities.

What evidence suggests that this intervention is effective for supporting families with developmental disabilities?

This trial will compare two approaches for families of children with developmental disabilities. The "Center Sessions" arm involves participants receiving psychoeducation and communication coaching. Studies have shown that programs designed for parents of children with developmental disabilities can improve family well-being and reduce stress. Research indicates that programs focusing on education about disabilities and improving communication skills effectively help families. These programs assist parents and siblings in better understanding and interacting with their child who has a disability. Reviews of various programs show improvements in family dynamics and children's learning. Overall, evidence suggests that well-planned programs can benefit both parents and siblings in families dealing with developmental disabilities.678910

Who Is on the Research Team?

EM

Edward M Cummings, PhD

Principal Investigator

University of Notre Dame

Are You a Good Fit for This Trial?

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.
See 1 more

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Center SessionsExperimental Treatment1 Intervention
Group II: At-homeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Notre Dame

Lead Sponsor

Trials
36
Recruited
60,000+

Published Research Related to This Trial

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.
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]

Citations

Families of Youth with Developmental Disabilities: a ...Our objective in this study is to test the efficacy for parents, TD siblings, and children with IDD of an adaptation of the psycho-educational and communication ...
A Review of Intervention Programs to Prevent and Treat ...The current review identified 17 controlled trials of nine intervention programs for young children with developmental disabilities.
The efficacy of interventions designed for parents ...The interventions designed for parents of children with DD result in an increase in positive functioning and a reduction in symptoms of mental health ...
Effectiveness of interventions for improving educational ...The review focusses on improving education outcomes for people with disabilities. Early childhood development (ECD) to improve development and ...
the Development of a Logic model AbstractTheory-based evaluation is centred around the description of the theory underlying a given intervention – effectiveness that can be derived from the scientific ...
Integrated Theory-Based Health and Development ...The purpose of this scoping review was to identify and describe the range of theory-based, multibehavioral health interventions aimed at improving two or more ...
Behavioral Approaches to Assessment and Early ...Estimates vary widely, but approximately 50% of individuals with IDD experience some form of problem behavior, with a smaller proportion (5%–10%) exhibiting ...
Timing and Intensity of Early Intervention Service Use and ...The data are clear: early interventions for children at risk are effective in improving outcomes and are cost-effective in the long-term. The ...
Functional analysis: Safety precautions and risk prevention.Implementing intensive intervention based on functional analysis (FA) outcomes can prove remarkably efficacious in managing challenging behavior.
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