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

Parent-Child Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706376
• Other study ID #: 22-08-7367
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: November 2023
• Source: University of Notre Dame
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: July 31, 2027
• Est. primary completion date: March 13, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent
• Parent-Child Relations
• Psychopathology
• Violence

Intervention

Behavioral:
• 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.
• 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).

Locations

Country	Name	City	State
United States	University of NotreDame	Notre Dame	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Notre Dame

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Primary	Adolescent Security in the Family Scale	Adolescent 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 adolescents in the treatment group will report higher levels of emotional security at T2, T3, and T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Primary	Adolescent Adjustment and Prosocial Skills	Adolescent Adjustment & Prosocial Skills will be measured using the Strengths and Difficulties questionnaire, which measures children's adjustment in 5 domains: emotional symptoms, conduct problems, hyperactivity/ inattention, peer relationship problems and prosocial skills. It has been successfully validated in Arabic (Alyhari & Goodman, 2006). We hypothesize that adolescents in the treatment group will report lower levels of adjustment problems at T3/T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Primary	Adolescent Posttraumatic Stress Symptoms	Adolescent Posttraumatic Stress will be assessed using the Child Posttraumatic Stress Symptom Index (Pynoos, Frederick & Nader, 1987), which has been successfully used with adolescents living in Palestine (Dubow, et al., 2012). WE hypothesize that adolescents in the PPFF condition will report lower levels of posttraumatic stress symptoms at T3 and T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Primary	Adolescent Resilience	Adolescent Resilience will be assessed using the Child and Youth Resilience Measure (CYRM; Ungar & Liebenberg, 2011), which assesses resilient functioning across three domains - individual resilience, relational resilience, and community resilience. The CYRM was developed in the context of a multi-national study that included a large sample drawn from Palestine, and as such, has established validity in the region (Ungar & Liebenberg, 2011). We hypothesize that adolescents in the treatment group will report higher levels of resilience at T3/T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Primary	Family-Wide Conflict	Interparental and family problem solving interactions will be coded in real time for constructive and destructive conflict behaviors using the Family Interactions Coding System (FICS; Bergman and Cummings, unpublished coding system) The FICS is a well-established system for coding conflict behaviors on a 5-point scale. Inter-rater reliability for observational codes using the FICS ranges from .94 to .98. We hypothesize the the PPFF program will be associated with reductions in family-wide conflict at T2, T3, and T4 and that improvements in conflict at T2 will predict adolescent adjustment at T3/T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Primary	Parent-Adolescent Attachment	Parent-Adolescent Attachment will be measured by adolescent report on the Inventory of Parent and Peer Attachment (IPPA; Greenberg & Armsden, 1987), which assesses both positive and negative dimensions of relationship quality with an attachment figure. Adolescents will complete the survey regarding their relationship with both their mother and father at all four time points of assessment. We hypothesize that adolescents in the treatment group will report improved attachment at T2, T3, and T4.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
Primary	Family conflict and cohesion	Family conflict and cohesion will be assessed using the conflict and cohesion subscales of the Family Environment Scale (Moos & Moos, 2002). All family members will complete these items at each assessment. We hypothesize that participation in the treatment condition will be associated with reduced conflict and improved cohesion for mothers, fathers, and adolescents.	baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up