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Center Sessions for Family Conflict

N/A
Recruiting
Led By Edward M Cummings, PhD
Research Sponsored by University of Notre Dame
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a program to help families that have a child with an intellectual or developmental disability. The program will provide education and communication coaching, and will be compared to families who only receive self-study materials. All subjects will be assessed before and after the program.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is not a drug trial but an educational and behavioral intervention, there aren't typical medical side effects. However, participants may experience emotional discomfort or stress during therapy sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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 family functioning -- Family Environment Scale (FES)
Change in family interactions in the home -- Daily Diaries
Change in hostile interparental conflict -- O'Leary Porter Scales (OPS)
+11 more
Secondary outcome measures
Change in adaptive functioning for individuals with IDD - Vineland Adaptive Behavior Scales II

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Center SessionsExperimental Treatment1 Intervention
Treatment condition in which participants receive psychoeducation and communication coaching.
Group II: At-homeActive Control1 Intervention
Active, self-study control condition in which participants receive regular communication with study personnel and self-study materials to review on their own.

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Who is running the clinical trial?

University of Notre DameLead Sponsor
33 Previous Clinical Trials
61,453 Total Patients Enrolled
Edward M Cummings, PhDPrincipal InvestigatorUniversity of Notre Dame

Frequently Asked Questions

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

Is this trial still recruiting participants?

"Affirmative. Clinicaltrials.gov data confirms that this medical trial, originally posted on August 4th 2017 is actively recruiting participants; 150 individuals are necessary to be recruited from 2 different locations."

Answered by AI

How many individuals are being administered treatment as part of this clinical trial?

"Confirmed. According to data found on clinicaltrials.gov, this research is presently recruiting patients - the trial was initially posted on August 4th 2017 and last updated April 11th 2022. Specifically, 150 participants are sought from 2 different sites."

Answered by AI
~4 spots leftby May 2024