ClinicalTrials.gg
RecruitingNCT05706376Updated Apr 23, 2026

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

An interventional study of Promoting Positive Family Futures and Treatment as Usual in Adolescent, Psychopathology and Parent-Child Relations, sponsored by University of Notre Dame. Recruiting at 1 site in United States. Open to participants aged 12 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by University of Notre Dame · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
12 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Adolescent
  • Psychopathology
  • Parent-Child Relations
  • Violence
03

In context

Lead sponsor

University of Notre Dame is the lead sponsor of 29 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Families with individuals with significant mental or physical impairments precluding their ability to participate in groups
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
900 participants (estimated)

Study arms

  • Experimental
    Promoting Positive Family Futures

    Behavioral: Promoting Positive Family Futures

  • Active comparator
    Treatment as Usual

    Behavioral: Treatment as Usual

Interventions

  • BehavioralPromoting 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.

  • BehavioralTreatment 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  2. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  3. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  4. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  5. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  6. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  7. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  8. Adolescent and Parent Resilience

    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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  9. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  10. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  11. 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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  12. Parent and adolescent emotion regulation

    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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

  13. Parent and adolescent well-being

    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.

    Time frame: baseline, 10 week follow-up, 6 month follow-up, 12 month follow-up

07

Study locations

1 of 1 sites recruiting
  • University of NotreDame
    Notre Dame, Indiana 46556, United States
    Recruiting
    • Laura Miller-Graff, PhD · Contactlmiller8@nd.edu · 574-631-3245
    • Laura Miller-Graff, PhD · Principal investigator
    • E M Cummings, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Mar 2027, 41 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2022
First posted
Jan 31, 2023
StartActual
Sep 19, 2023
Primary completionEst.
Mar 13, 2027
CompletionEst.
Jul 31, 2027
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05706376
Lead sponsor
University of Notre Dame
Responsible party
Sponsor
First posted
Jan 31, 2023
Start date
Sep 19, 2023
Primary completion
Mar 13, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Apr 23, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion