NCT04980794 · University of Notre Dame
The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families
What this study is about
This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.
View original scientific description
This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.
Interventions
BEHAVIORAL
Parent-child intervention
Families (two adult caregivers, child between 4 and 17) receive four interactive, asynchronous psychoeducation modules to review on their own paired with weekly contact with a communication coach and two live sessions with a communication coach to discuss psychoeducation, receive feedback on their interactions, and practice a communication technique.
BEHAVIORAL
Self-study Intervention
Families (two adult caregivers) receive information in a newsletter format to review on their own, paired with weekly contact from a communication coach to answer questions and direct their attention toward specific topics in the newsletter.
Primary outcome measures
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 1 year
Youth Adjustment
Center for Epidemiological Studies Depression Scale (CESD)
Time frame: 1 year
Youth Adjustment
Revised Children's Manifest Anxiety Scale (RCMAS)
Time frame: 1 year
Youth Adjustment
Child Behavior Checklist (CBCL)
Time frame: 1 year
Youth Adjustment
O'Leary Porter Scale (OPS)
Time frame: 1 year
Interadult Conflict
Family Interactions Coding Scale
Time frame: 1 year
Observational measures of interadult and family conflict
Security in the Marital System Questionnaire (SIMS-PR)
Time frame: 1 year
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Security in the Subsystem (SIS)
Time frame: 1 year
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Security in the Family System (SIFS)
Time frame: 1 year
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Organizational Characteristics Measure (purpose created measure of organizational characteristics)
Time frame: 4 years
Testing organizational factors associated with program effectiveness
Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)
Time frame: 4 years
Testing organizational factors associated with program effectiveness
Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)
Time frame: 4 years
Testing organizational factors associated with program effectiveness
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Two parents or primary caregivers
- Child between 4 and 17 years old
- English literate
- Able/willing to participate through the 12-month follow up assessment.
Exclusion criteria
- Families who cannot communicate in English
- Single parent families
Where
- Fort Wayne, Indiana
- Indianapolis, Indiana
- Notre Dame, Indiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 15, 2024 · Source of record for eligibility and locations