Mental Health

Self-Help Plus for refugee mothers in Rhino Refugee Settlement, Uganda (SEED): study protocol for a cluster-randomized controlled trial assessing intergenerational effects on preschool-aged children.

TL;DR

This paper describes a protocol for a cluster-randomized controlled trial enrolling 720 mother-preschool-aged child dyads in Rhino Refugee Settlement, Uganda, to assess whether Self-Help Plus (SH+) reduces maternal psychological distress and generates intergenerational benefits for children's psychosocial wellbeing at 12 months post-intervention.

Key Findings

Self-Help Plus (SH+) has shown promising short-term effects in reducing psychological distress among South Sudanese refugee women in Rhino Camp, Uganda, based on prior evidence.

  • SH+ is described as 'a brief, low-intensity WHO group intervention based on Acceptance and Commitment Therapy'
  • Prior evidence was obtained in Rhino Camp, Uganda, with South Sudanese refugee women
  • Key questions remain regarding 'the durability of these effects and whether improvements in maternal mental health translate into measurable gains in children's own wellbeing and early development'

The trial will enroll 720 mother-preschool-aged child dyads from 24 villages in Rhino Refugee Settlement, Uganda.

  • Children are aged 3–5 years at enrollment
  • 24 villages are randomized 1:1 to receive either SH+ and Enhanced Usual Care (EUC), or EUC only
  • The design is a two-arm, parallel-group cluster-randomized controlled trial
  • Assessments are conducted at baseline (T0), 3 months (T1), and 12 months (T2) post-intervention

The primary outcome of the trial is maternal psychological distress measured by the Kessler-6 at 12 months post-intervention.

  • The Kessler-6 is the instrument used to measure the primary outcome
  • The primary outcome is assessed at T2 (12 months post-intervention)
  • Analyses will follow an intention-to-treat approach, adjusting for clustering and relevant covariates

The key secondary outcome is parent-reported child psychosocial wellbeing measured by the Kiddy-KINDLR at 12 months post-intervention.

  • The Kiddy-KINDLR is the instrument used to assess the key secondary outcome
  • Additional secondary outcomes include 'additional indicators of maternal wellbeing and mental health, parenting practices, and child outcomes assessed across study time points, including psychosocial difficulties and child self-reported wellbeing'
  • Secondary outcomes are assessed across T0, T1, and T2 time points

Growing up in adversity creates enduring deficits in children's cognitive and socio-behavioral skills with long-term societal consequences.

  • Such deficits 'undermine later-life productivity, reduce human capital, and increase social costs'
  • War-related displacement places 'mothers and young children at exceptional risk for psychological distress and impaired functioning, with potential long-term consequences for both generations'
  • Evidence on 'scalable approaches that generate such intergenerational benefits remains limited' in low-resource humanitarian settings

The trial is registered prospectively on ClinicalTrials.gov and aims to inform scalable intervention strategies for humanitarian contexts.

  • ClinicalTrials.gov registration number: NCT07062341
  • Prospectively registered on July 11, 2025
  • Findings are intended to 'inform scalable intervention strategies to promote psychological resilience and child development in humanitarian contexts'

Have a question about this study?

Citation

Vassiliou P, Ainamani H, Döring S, Gredebäck G, Leku M, Peltonen K, et al.. (2026). Self-Help Plus for refugee mothers in Rhino Refugee Settlement, Uganda (SEED): study protocol for a cluster-randomized controlled trial assessing intergenerational effects on preschool-aged children.. Trials. https://doi.org/10.1186/s13063-026-09546-1