Hope Groups: Parenting and Mental Health Among Refugees in the Middle East

April 7, 2026 updated by: University of Oxford

Hope Groups: A Small-Scale Randomised Controlled Trial Of Psychosocial And Parenting Support Groups For Palestinian Caregivers Affected By War In The Middle East

This research is testing if 'Hope Groups' -- a psychosocial, mental health, parenting strengthening, and violence prevention support group program -- work to help Palestinian caregivers displaced by war.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a carbon-copy of a preregistration submitted to Open Science Framework on January 26, 2025.

This research is a two-armed pragmatic randomised controlled trial testing the effectiveness of 'Hope Groups' -- a psychosocial, mental health, parenting strengthening, and violence prevention support group program -- via a randomised roll-out design among Palestinian caregivers. This randomised controlled trial (RCT) will compare participants receiving Hope Groups (intervention arm) to a wait-list control group. As the intervention cannot be implemented simultaneously to all participants (due to staff constraints), a randomised roll out of the intervention enables rigorous evaluation while prioritizing delivery of potentially beneficial interventions to all war-affected participants. The unit of randomisation is the individual participant.

  • Main study site: AMMAN, JORDAN (N=490) This randomised roll-out RCT will utilise a staircase design and occur across five waves. Charity partners will approach participants to assess interest in participation. Participants who express interest will be compiled into a list. From this list, investigators will randomly select participants for each cohort, then individually randomise participants within each cohort to intervention or wait-list control.
  • In Wave 1, Parents/Caregivers will be individually randomised to the intervention arm (immediate receipt of Hope Groups) or control arm (wait-list for Hope Groups). Both arms will include 35 participants (n=70 total for Wave 1).
  • In Wave 2, Parents/Caregivers will be individually randomised to either intervention arm (immediate receipt of Hope Groups) or control arm (wait-list for Hope Groups). Both arms will include 40 participants (n=80 total for Wave 2).
  • In Wave 3, Parents/Caregivers will be individually randomised to either intervention arm (immediate receipt of Hope Groups) or control arm (wait-list for Hope Groups). Both arms will include 50 participants (n=100 total for Wave 3).
  • In Wave 4, Parents/Caregivers will be individually randomised to either intervention arm (immediate receipt of Hope Groups) or control arm (wait-list for Hope Groups). Both arms will include 60 participants (n=120 total for Wave 4).
  • In Wave 5, Parents/Caregivers will be individually randomised to either intervention arm (immediate receipt of Hope Groups) or control arm (wait-list for Hope Groups). Both arms will include 60 participants (n=120 total for Wave 5).
  • The study is implemented across 5 waves to enable long-term follow-up comparisons between treated participants in waves 1-3 at 6- and 12- months post-intervention with untreated participants in waves 4-5.
  • Potential Small Pilot: WEST BANK (N=55) Investigators aim to additionally conduct a small pilot in the West Bank which will include one wave of 55 families from the West Bank. Parents/Caregivers will be individually randomised to either intervention arm (immediate receipt of Hope Groups, n=27) or control arm (wait-list for Hope Groups, n=28). While the West Bank data is too small of a sample to be powered to show statistically significant results, it will provide preliminary evidence on if the effectiveness of the intervention in the West Bank is similar to the effectiveness in Jordan. Investigators will conduct an analysis for the intervention effects in Jordan data separately, then do a second analysis to assess if the intervention effects in the West Bank are statistically equivalent with the effects in Jordan. Given uncertainties in the region, this pilot may not occur within the same timeframe as the Jordan RCT. This is to be determined as circumstances allow.

Study Type

Interventional

Enrollment (Estimated)

490

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 Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant is living in one of our partner refugee camps.
  • Participant is a parent/caregiver for one or more child (of any age).
  • Participant is over the age of 18.
  • Participant has high, medium, or low literacy. (Note: This is in order to use our Hope Groups programme guide. Our team is concerned that individuals with no literacy would need more audio files, rather than just a text-driven participant guide. If Hope Groups demonstrate effectiveness in this pilot, investigators will have focus groups with low-literacy participants, to create a future version which is suitable for people of all literacy backgrounds.)
  • Participant consents to participate in the study.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hope Groups Intervention Arm
The intervention arm receives the 10-session mental health and parenting intervention called 'Hope Groups'.
Behavioral: Hope Groups
A 10-session psychosocial, mental health, parenting, and violence prevention support group of 8-12 parents/caregivers.
No Intervention: Wait-List Comparison Group
The wait-list comparison group is told that they are on a wait-list to receive a mental health and parenting intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Violence Against Children
Time Frame: All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.
Violence Against Children, measured via the ISPCAN Child Abuse Screening Tool for parents (ICAST-Parent). Answer options are reported on ordinal scales indicating no violence against children to frequent violence against children (0-3). Higher scores indicate higher levels of violence against children.
All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.
Mental health
Time Frame: All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.
Mental health of parents/caregivers, measured via Patient Health Questionnaire - 4 (PHQ-4). Answer options are reported on ordinal scales ranging from 0-3. Higher scores indicate higher levels of depression/anxiety.
All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Practices
Time Frame: All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.
Parenting Practices, measured via Alabama Parenting Questionnaire (APQ). Answer options are reported in days of occurrence in the past week (ranging 0-7). Higher levels indicate higher usage of positive parenting practices.
All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.
Child behavioural issues
Time Frame: All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.
Child behavioural issues and child well-being, measured via Child and Adolescent Behavior Inventory (CABI). Answers are reported on ordinal response scales ranging from 0-3. Higher scores indicate higher internalising and externalising problems in children.
All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.
Post-traumatic growth
Time Frame: All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.
Post-traumatic growth is an important element of the mental health of parents/caregivers, measured via the Post-Traumatic Growth Inventory, which uses ordinal answer responses ranging from 1-5. Higher scores indicate higher levels of post-traumatic growth.
All participants complete surveys at baseline and 6-weeks post-baseline (after completion of 10-session intervention). Participants in Wave 1-3 of the randomised roll-out trial additionally complete surveys at 6- and 12- months post-baseline.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Baseline and 6-weeks post-baseline (after completion of 10-session intervention)
Caregiver/parent stress and caregiver/parent physical health, measured via blood pressure reading (in Jordan only)
Baseline and 6-weeks post-baseline (after completion of 10-session intervention)
Caregiver Physical Health: Heart Rate
Time Frame: Baseline and 6-weeks post-baseline (after completion of 10-session intervention).
Caregiver/parent stress and caregiver/parent physical health, measured via heart rate reading (in Jordan only)
Baseline and 6-weeks post-baseline (after completion of 10-session intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Sanadak

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)

February 5, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 760866
  • https://osf.io/ewaq4/overview (Registry Identifier: Open Science Framework (OSF). This is a carbon-copy of a preregistration registered to OSF on January 26, 2025.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All outcomes and basic demographic information.

IPD Sharing Time Frame

Data can be made available upon request, in accordance with data privacy policies. Fully anonymous data will be posted on Open Science Framework.

IPD Sharing Access Criteria

Data can be made available upon request to the Sydney Tucker (sydney.tucker@spi.ox.ac.uk), in accordance with data privacy policies, after the conclusion of the RCT (July 2026). After the primary, secondary, and tertiary trial outcomes have been published, fully anonymous data will be posted on Open Science Framework.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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