Clinical trial NCT04980794: The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families
Official title: Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Conflict
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 1800
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two conditions.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The goal of the study is to evaluate the effectiveness of a program to improve mental health in families by reducing stress and supporting effective communication and conflict resolution.

Families will be randomly assigned to one of two conditions: in the self-study condition, families will receive information to review on their own, paired with regular (weekly) contact from a family coach; in the second condition, families will receive information to review on their own, regular contact from a coach, and will participate in video sessions with a family coach who will provide feedback on their interactions and coaching on their use of a communication technique. Data collection, management and analysis will be conducted by researchers at the University of Notre Dame, but the intervention will occur through community organizations in three cities in Indiana, allowing for tests of the effectiveness of the program when it is implemented in community settings. Families will participate in a pre-test assessment, a four-week intervention, a post-test assessment, and a one-year follow up assessment. Also evaluated will be organizational factors and factors that impact ultimate implementation and scalability of the program in community settings.

Eligibility criteria: 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

Primary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 1 year
measure: Center for Epidemiological Studies Depression Scale (CESD)
timeFrame: 1 year
measure: Revised Children's Manifest Anxiety Scale (RCMAS)
timeFrame: 1 year
measure: Child Behavior Checklist (CBCL)
timeFrame: 1 year
measure: O'Leary Porter Scale (OPS)
timeFrame: 1 year
measure: Family Interactions Coding Scale
timeFrame: 1 year
measure: Security in the Marital System Questionnaire (SIMS-PR)
timeFrame: 1 year
measure: Security in the Subsystem (SIS)
timeFrame: 1 year
measure: Security in the Family System (SIFS)
timeFrame: 1 year
measure: Organizational Characteristics Measure (purpose created measure of organizational characteristics)
timeFrame: 4 years
measure: Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)
timeFrame: 4 years
measure: Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Fort Wayne Center for Children and Families
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Virtual Site
state: Indiana
city: Notre Dame
country: United States
facility: University of Notre Dame
state: Indiana
Study officials:
References: