An Evidence-based Family Support Program for Parents and... | NCT05706376

Status Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Promoting Positive Family Futures	Experimental		Behavioral: Promoting Positive Family Futures
Treatment as Usual	Active Comparator		Behavioral: Treatment as Usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Promoting Positive Family Futures	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parental Depression	Parental Depression will be measured using the Patient Health Questionnaire (PHQ9; Kronke & Spitzer, 2009), which has established validity in both English and Arabic, and has been successfully used in Palestinian samples (Hobfoll, et al., 2011). We hypothesize that parents in the treatment group will report lower levels of depressed mood at T2, T3 and T4 and that change in parental depression at T2 will mediate the relationship between intervention and adolescent adjustment at T3/T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Parental Anxiety	Parental Anxiety will be measured using the GAD-7 (Spitzer et al., 1999), which has established validity in both English and Arabic. We hypothesize that parents in the treatment group will report lower levels of anxiety at T2, T3 and T4 and that change in parental anxiety at T2 will mediate the relationship between intervention and adolescent adjustment at T3/T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Parental Posttraumatic Stress	Parent posttraumatic stress will be assessed using the PTSD Checklist - 5, which assesses symptoms of posttraumatic stress in the domains of re-experiencing, avoidance, negative mood and cognition, and hyperarousal (Weathers, et al., 2013) and has been successfully used in the region (Bensimon, Bodner, & Shrira, 2017). We hypothesize that parents in the treatment group will report lower levels of posttraumatic stress at T2, T3 and T4 that change in parental posttraumatic stress at T2 will mediate the relationship between intervention and adolescent adjustment at T3/T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Parent Emotional Security in Family	Parent Emotional Security in the Family will be assessed using the Security in the Family System Scale (Forman & Davies, 2005), which has established psychometric properties and has successfully been used in other conflict settings (Cummings, et al., 2010). We hypothesize that mothers and fathers in the treatment group will report higher levels of emotional security at T2, T3, and T4 and that change parent emotional security at T2 will indirectly affect adolescent adjustment and emotional security at T3/T4.

Eligibility Module