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| ID | Type | Description | Link |
|---|---|---|---|
| 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. |
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| Name | Class |
|---|---|
| Sanadak | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hope Groups Intervention Arm | Experimental | The intervention arm receives the 10-session mental health and parenting intervention called 'Hope Groups'. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hope Groups | Behavioral | A 10-session psychosocial, mental health, parenting, and violence prevention support group of 8-12 parents/caregivers. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | 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 |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sydney F Tucker | Contact | +1 706 969 8692 | sydney.tucker@spi.ox.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jerash Camp | Recruiting | Jerash | Jordan |
All outcomes and basic demographic information.
Data can be made available upon request, in accordance with data privacy policies. Fully anonymous data will be posted on Open Science Framework.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2026 | Jun 9, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2026 | Jun 9, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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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.)
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Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
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| 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. | 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. | 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. |
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). |