An Evidence-based Family Support Program for Parents and Children in Palestine: a Theory-based Intervention

NCT ID: NCT05706376

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2027-07-31

Brief Summary

Few evidence-based programs exist to support children and families affected by sociopolitical conflict, despite documented evidence of their heightened risk for emotional and behavioral adjustment problems associated with exposure to conflict and violence at multiple levels of the social ecology (e.g., political, community, and family). Thus, a critical need exists for an evidence-based program to ameliorate the impact of political violence on the overall well-being of children and families. The current study will conduct a rigorous evaluation of a theoretically-driven, family-based intervention program in Palestine, including both the West Bank and Gaza. Firmly grounded in the cultural context of Palestine but with broad implications for individuals exposed to sociopolitical violence, the long-term goal of this project is to provide a family-focused intervention program (Promoting Positive Family Futures; PPFF) that may facilitate individuals' sense of safety and support in the context of chronic adversity. The objective is to evaluate this intervention program in the context of a randomized clinical trial (RCT) in the West Bank and Gaza (N=300). The central hypothesis is that the program will have direct positive effects on family conflict, parent psychopathology and parental security in the family as well as on adolescent emotional security in the family, with cascading effects on adolescent adjustment. Consistent with family systems theory, we further hypothesize that treatment effects on parents will mediate on the effects of the treatment on adolescent adjustment. The rationale is that bolstering resilience in family systems is a key approach to promoting positive functioning in families exposed to chronic violence. The hypothesis will be evaluated with three specific aims: 1) evaluate the efficacy of an evidence-based family support program; 2) examine process models of treatment change, and 3) examine interrelations between parent and child functioning. To achieve these aims, the study will be an RCT employing a longitudinal design (N=300) with multi-method assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Families included in the study will be evenly divided between the West Bank (n=150) and Gaza Strip (n=150). Families will be randomized into the intervention condition (PPFF) or treatment as usual (TAU). Each territory will have an implementing partner, and implementing partners and investigators will work together to ensure the study procedures are implemented in parallel across sites. Data collection will be conducted by trained research staff from a third-party survey and policy research organization. The proposal seeks to shift current research and clinical paradigms in these contexts by employing novel theoretical concepts, approaches, and methodologies. The contribution will be significant by 1) further developing new directions for empirically-based interventions in these high-risk contexts, and 2) advancing a relatively brief, cost-effective program that can be readily implemented to help children and families exposed to continuing conflict in Palestine, with the potential to be brought to scale in other contexts.

Conditions

Adolescent; Psychopathology; Parent-Child Relations; Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Promoting Positive Family Futures

Group Type: EXPERIMENTAL

Promoting Positive Family Futures

Intervention Type: BEHAVIORAL

Promoting Positive Family Futures is a group-based program that aims to help parents and their adolescent children (13-16 yrs) cope with chronic violence by developing emotional and cognitive awareness, learning constructive conflict resolution strategies, and developing family-wide emotional security and positive family relationships. Emotional Security Theory is the foundational conceptual model for the program, and as such, the PPFF focuses on promoting family-wide communication and establishing emotional security in both the family and community across multiple sessions.Firmly grounded the cultural context of Palestine, the intervention also incorporates intervention elements derived from social ecological theories of resilience, and cognitive behavioral approaches to coping. In total, the program includes 8 sessions lasting approximately 1.5 hours each.

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Families assigned to the TAU condition will participate in a common service offered by both PCC and CRS - a weekly adolescent-only support group. Both CRS and PCC conduct extended group programs for children and adolescents (24 sessions at PCC; 25 sessions at CRS).

Interventions

Promoting Positive Family Futures

Promoting Positive Family Futures is a group-based program that aims to help parents and their adolescent children (13-16 yrs) cope with chronic violence by developing emotional and cognitive awareness, learning constructive conflict resolution strategies, and developing family-wide emotional security and positive family relationships. Emotional Security Theory is the foundational conceptual model for the program, and as such, the PPFF focuses on promoting family-wide communication and establishing emotional security in both the family and community across multiple sessions.Firmly grounded the cultural context of Palestine, the intervention also incorporates intervention elements derived from social ecological theories of resilience, and cognitive behavioral approaches to coping. In total, the program includes 8 sessions lasting approximately 1.5 hours each.

Intervention Type: BEHAVIORAL

Treatment as Usual

Families assigned to the TAU condition will participate in a common service offered by both PCC and CRS - a weekly adolescent-only support group. Both CRS and PCC conduct extended group programs for children and adolescents (24 sessions at PCC; 25 sessions at CRS).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• a willing adolescent between the ages of 13 and 16
• assuming a two-parent family, a mother and father willing to participate
• within the service area of implementing organizations

Exclusion Criteria

• Families with individuals with significant mental or physical impairments precluding their ability to participate in groups

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Notre Dame

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of NotreDame

Notre Dame, Indiana, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Laura Miller-Graff, PhD

Role: primary

lmiller8@nd.edu

574-631-3245

Laura Miller-Graff, PhD

Role: backup

E M Cummings, PhD

Role: backup

Other Identifiers

22-08-7367

Identifier Type: -

Identifier Source: org_study_id