Mental HealthNCT07506421
Hope Groups: Parenting and Mental Health Among Refugees in the Middle East
A study testing Hope Groups in people with Mental Health and Violence Against Children, run by University of Oxford at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Violence Against Children
- What is being tested?
- Hope Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteJordan
- Study dates
- 5 Feb 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jerash Camp
Jerash
Sydney F Tucker, +447887444206, sydney.tucker@spi.ox.ac.uk
About this study
Official 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
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.
Read the 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.
- Conditions
- Mental Health, Violence Against Children
- Being tested
- Hope Groups
- Keywords
- War, Displacement, Parenting, Violence Against Children, Refugee
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hope GroupsBehavioural
A 10-session psychosocial, mental health, parenting, and violence prevention support group of 8-12 parents/caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Hope Groups Intervention Arm | Experimental | The intervention arm receives the 10-session mental health and parenting intervention called 'Hope Groups'. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start5 Feb 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.)
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Sanadak
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506421
- Sponsor's protocol ID
- 760866
- Other IDs
- https://osf.io/ewaq4/overview
- Status last verified
- Feb 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All outcomes and basic demographic information.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07506421
- Acronym / sponsor ID
- 760866
- Conditions
- Mental Health, Violence Against Children
- Keywords
- War, Displacement, Parenting, Violence Against Children, Refugee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Sanadak
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.)
| Arm | Type | Receives |
|---|---|---|
| Hope Groups Intervention Arm | Experimental | Behavioral: Hope GroupsThe intervention arm receives the 10-session mental health and parenting intervention called '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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hope GroupsA 10-session psychosocial, mental health, parenting, and violence prevention support group of 8-12 parents/caregivers. | Behavioural | Hope Groups Intervention Arm |
Primary outcome
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. All outcomes and basic demographic information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hope Groups in people with Mental Health and Violence Against Children, run by University of Oxford at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sydney F Tucker (+1 706 969 8692, sydney.tucker@spi.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.