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

NCT07506421 | Recruiting DMC

• 2 other identifiers: 760866https://osf.io/ewaq4/overview
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health; Violence Against Children

Keywords

War; Displacement; Parenting; Violence Against Children; Refugee

Outcome Measures

Primary Outcomes (2)

• Violence Against Children

  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

  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 Outcomes (3)

• 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

  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

  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 Outcomes (2)

• Blood Pressure

  Baseline and 6-weeks post-baseline (after completion of 10-session intervention)

• Caregiver Physical Health: Heart Rate

  Baseline and 6-weeks post-baseline (after completion of 10-session intervention).

Study Arms (2)

Hope Groups Intervention Arm

EXPERIMENTAL

The intervention arm receives the 10-session mental health and parenting intervention called 'Hope Groups'.

Behavioral: Hope Groups

Wait-List Comparison Group

NO INTERVENTION

The wait-list comparison group is told that they are on a wait-list to receive a mental health and parenting intervention.

Interventions

Hope Groups BEHAVIORAL

A 10-session psychosocial, mental health, parenting, and violence prevention support group of 8-12 parents/caregivers.

Hope Groups Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Sanadak: collaborator

Study Sites (1)

Jerash Camp

Jerash, Jordan

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Sydney F Tucker

CONTACT

+1 706 969 8692; sydney.tucker@spi.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a Staircase Trial Design, which is a randomised roll-out design adapted from Stepped Wedge Trials (Grantham, 2024). The post-intervention analysis will combine intervention and control arm comparisons across all waves. Long-term follow-up analyses will be conducted by comparing treated participants from early waves (waves 1-3) at 6- and 12-months post-intervention with untreated participants in later waves (waves 4-5). A full statistical analysis plan will be registered. \- (Grantham KL, Forbes AB, Hooper R, Kasza J. The staircase cluster randomised trial design: A pragmatic alternative to the stepped wedge. Stat Methods Med Res. 2024 Jan;33(1):24-41. doi: 10.1177/09622802231202364. Epub 2023 Nov 30. PMID: 38031417; PMCID: PMC10863363.)

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 1, 2026
• Study Start: February 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

JO (1)