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NCT Number: NCT07506421

Hope Groups: Parenting and Mental Health Among Refugees 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.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being Violence Against Children

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hope Groups

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sydney F Tucker

CONTACT

[email protected]

+1 706 969 8692

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Sanadak

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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