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.