What side effects are associated with this type of intervention?

Psychoeducation and communication coaching, which aim to improve family dynamics and communication skills, generally have minimal side effects. Participants may experience temporary discomfort or emotional distress as they confront and discuss sensitive issues. Additionally, there may be initial resistance or reluctance to engage in the process, which can cause short-term tension within the family. However, these side effects are typically mild and transient, with the overall goal of fostering healthier family interactions and reducing conflict.

What prior FDA approvals exist?

There are no specific FDA-approved medications for the treatment of family conflict. However, psychoeducation and communication coaching are common non-pharmacologic interventions used to improve family dynamics and communication skills. These interventions are often part of broader therapeutic approaches such as family therapy, cognitive-behavioral therapy (CBT), and other psychosocial treatments. These methods aim to educate family members about effective communication strategies, conflict resolution, and emotional regulation, thereby improving overall family functioning.

What other types of research exist?

Promising alternatives to Psychoeducation and Communication Coaching for improving family dynamics and communication skills include: 1) Mindfulness-Based Interventions, which help family members develop awareness and emotional regulation; 2) Emotionally Focused Family Therapy, which focuses on improving emotional bonds and attachment within the family; 3) Technology-Assisted Family Therapy, utilizing apps and online platforms to facilitate therapy and communication exercises; and 4) Integrative Behavioral Couple Therapy, which combines behavioral techniques with emotional acceptance strategies to improve interactions and resolve conflicts.

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Family Program for Developmental Disabilities

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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in adaptive functioning for individuals with IDD - Vineland Adaptive Behavior Scales II

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Psychoeducation and communication coaching are common treatments for family conflict that aim to improve family dynamics and communication skills. Psychoeducation involves educating family members about the nature of conflicts, underlying psychological factors, and effective coping strategies. This helps family members understand each other's perspectives and reduces blame and misunderstandings. Communication coaching focuses on teaching effective communication techniques, such as active listening, empathy, and assertiveness, which facilitate healthier interactions and conflict resolution. These treatments are crucial for family conflict patients as they promote a supportive and understanding environment, reduce stress, and enhance overall family functioning.

Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations.