NCT07062341

Self-Help Plus to Enhance Early Development: A Cluster-Randomized Controlled Trial of Maternal Mental Health, Child Cognitive Abilities, and Socio-Behavioral Skills Among Refugee Mothers and Their Preschool-Aged Children in Rhino Camp, Uganda

Building Resilience in the Aftermath of Displacement: The Intergenerational Effects of a Randomized Mental Health Intervention for Refugee Families

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 725 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates whether the group-based mental health program Self-Help Plus (SH+) can improve the mental health, wellbeing, and functioning of refugee mothers and their preschool-aged children living in Rhino Refugee Settlement (Rhino Camp), Uganda. SH+ is a stress management course developed by the World Health Organization for people affected by adversity. A previous study in this setting found that SH+ improved mental health outcomes among South Sudanese refugee women (Tol et al., 2020). However, it remains unclear whether these effects are sustained over time and whether improvements in maternal mental health also lead to positive outcomes for children. This study asks two main research questions: * Does SH+ lead to lasting improvements in maternal mental health one year after the intervention? * Does SH+ administered to mothers improve children's wellbeing? The trial's main focus is on two outcomes assessed 12 months post-intervention: the primary outcome is maternal psychological distress (Kessler-6; K6), and the key secondary outcome is children's psychosocial wellbeing (Kiddy-KINDLR; parent report). To answer these questions, this study will employ a cluster-randomized controlled trial with two arms. Villages are randomized to receive either SH+ plus Enhanced Usual Care (EUC) or EUC only (active control). Outcomes are assessed at baseline, 3 months post-intervention, and 12 months post-intervention (the primary endpoint). In addition to the primary outcome and key secondary outcome, the study includes a broader set of secondary outcomes capturing maternal mental health and functioning, parenting, and child wellbeing. The study also collects prespecified exploratory outcomes, including socio-behavioral skills of mothers and children measured using incentivized economic games, as well as child cognitive development. The study uses caregiver reports, direct child assessments, and incentivized tasks to measure outcomes. By integrating mental health, developmental, and behavioral measures, this study examines whether SH+ produces lasting mental health benefits and whether improvements in maternal mental health translate into positive outcomes for preschool-aged children in an adverse humanitarian setting.

Detailed description

This cluster-randomized controlled trial (cRCT) evaluates the sustained and intergenerational impacts of the World Health Organization's Self-Help Plus (SH+) program among refugee mothers and their preschool-aged children in Rhino Refugee Settlement, Uganda. SH+ is a brief, low-intensity, group-based stress management intervention designed for humanitarian settings. Grounded in Acceptance and Commitment Therapy, SH+ is facilitated by trained non-specialist peers from the local refugee community and consists of five weekly audio-guided group sessions supported by a self-help book. The trial enrolls 720 mother-child dyads across 24 village clusters randomized 1:1 to one of two arms: (i) SH+ plus Enhanced Usual Care (EUC), or (ii) EUC only (active control). EUC consists of a brief psychoeducation session and referral information for available mental health resources. Assessments are conducted at baseline, 3 months post-intervention, and 12 months post-intervention (primary endpoint). Child cognitive skills and the socio-behavioral skills of mothers and children are assessed only at baseline and 12 months. Cluster randomization at the village level is used because SH+ is delivered in group sessions within villages and to minimize contamination. This trial is designed around a prespecified outcome hierarchy that prioritizes a single primary outcome and a single key secondary outcome at the 12-month endpoint. The primary outcome is maternal psychological distress (Kessler-6; K6) at 12 months. The key secondary outcome is child psychosocial wellbeing at 12 months, measured with the parent-report Kiddy-KINDLR. Analyses of this outcome follow those of the primary outcome in a prespecified sequence to preserve the trial's main inferential focus. In addition, the study includes secondary outcomes capturing broader maternal mental health and functioning, parenting practices, and child wellbeing and functioning. The study also collects prespecified exploratory outcomes, including socio-behavioral skills of mothers and children measured using incentivized economic games, and child cognitive development. Outcomes are assessed through caregiver interviews, direct child assessments, and age-adapted incentivized tasks. The trial provides a rigorous test of whether a scalable maternal mental health intervention can produce durable benefits for mothers, and whether improvements in maternal mental health translate into benefits for young children in a protracted displacement setting.

Conditions

• Mental Health
• Psychological Distress
• Child Wellbeing
• Child Mental Health

Interventions

Type	Name	Description
BEHAVIORAL	Self-Help Plus (SH+)	SH+ is a low-intensity, scalable stress management intervention developed by the World Health Organization. It is designed for delivery in humanitarian settings by non-specialist facilitators. The intervention consists of five 2-hour group sessions delivered via pre-recorded audio, supported by an illustrated guidebook adapted to the local cultural and linguistic context (Juba Arabic). Sessions teach mindfulness, acceptance, and value-driven behavior based on principles from Acceptance and Commitment Therapy. In this study, SH+ is delivered to 12 groups of up to 30 South Sudanese refugee mothers in Rhino Camp, Uganda, by trained lay peers from the refugee community. The intervention is paired with Enhanced Usual Care.
BEHAVIORAL	Enhanced Usual Care (EUC)	EUC consists of a one-time, brief psychoeducation session lasting approximately 15 minutes, delivered individually by a trained lay provider under clinical supervision. The session focuses on helping participants understand and manage common symptoms of psychological distress-particularly local expressions such as "overthinking"-and introduces simple self-management strategies. Participants are also provided with information about available mental health and psychosocial support services within Rhino Camp, including referral pathways to professional care and community-based resources. This intervention serves as a minimal yet contextually relevant comparator that controls for attention and information exposure while remaining distinct from structured therapeutic interventions like SH+.

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-07-14
• Last updated: 2026-02-12

Locations

1 site across 1 country: Uganda