Clinical trial NCT05706376: An Evidence-based Family Support Program for Parents and Children in Palestine: a Theory-based Intervention
Official title: An Evidence-based Family Support Program for Parents and Children in Palestine: a Theory-based Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent
Psychopathology
Parent-Child Relations
Violence
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 900
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Parental Depression
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Parental Anxiety
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Parental Posttraumatic Stress
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Parent Emotional Security in Family
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Adolescent Security in the Family Scale
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Adolescent Adjustment and Prosocial Skills
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Adolescent Posttraumatic Stress Symptoms
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Adolescent and Parent Resilience
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Family-Wide Conflict
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Parent-Adolescent Attachment
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Family conflict and cohesion
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Parent and adolescent emotion regulation
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
measure: Parent and adolescent well-being
timeFrame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Notre Dame
country: United States
facility: University of NotreDame
state: Indiana
Study officials:
References: