- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706376
An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention
April 20, 2026 updated by: University of Notre Dame
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
900
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Indiana
-
Notre Dame, Indiana, United States, 46556
- Recruiting
- University of NotreDame
-
Contact:
- Laura Miller-Graff, PhD
- Phone Number: 574-631-3245
- Email: lmiller8@nd.edu
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Principal Investigator:
- Laura Miller-Graff, PhD
-
Principal Investigator:
- E M Cummings, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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).
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|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Depression
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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 Posttraumatic Stress
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
|
|
Adolescent Security in the Family Scale
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
|
|
Adolescent Adjustment and Prosocial Skills
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
|
|
Adolescent Posttraumatic Stress Symptoms
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
|
|
Family-Wide Conflict
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
|
|
Parent-Adolescent Attachment
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
|
|
Family conflict and cohesion
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
|
|
Parental Anxiety
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
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
|
|
Adolescent and Parent Resilience
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
Adolescent and Parent Resilience will be assessed using the Child and Youth Resilience Measure/Adult 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
|
|
Parent and adolescent emotion regulation
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
Cognitive strategies for emotion regulation will be assessed using the Emotion Regulation Questionnaire (Gross & John, 2003).
We hypothesize that parents and adolescents participating in PPFF will have better emotion regulation at post-test, which will in turn predict better mental health outcomes at each follow-up.
|
baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
|
Parent and adolescent well-being
Time Frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
Wellbeing will be assessed using the WHO-5 Wellbeing index.
We hypothesize that parents and adolescents participating in the PPFF program will have higher levels of wellbeing at all follow-up assessments as compared to the TAU group.
|
baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2023
Primary Completion (Estimated)
March 13, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
September 19, 2022
First Submitted That Met QC Criteria
January 20, 2023
First Posted (Actual)
January 31, 2023
Study Record Updates
Last Update Posted (Actual)
April 23, 2026
Last Update Submitted That Met QC Criteria
April 20, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-08-7367
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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