Active — Not RecruitingNot Applicable

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

Uganda725 participantsStarted 2025-10-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (Mothers): * Aged 18 years or older * Able to speak and understand Juba Arabic * Mother of a child aged 3-4 years at the time of enrollment * Not planning to move away from the study area (Rhino Camp) within the next year * At least moderate psychological distress, defined as a score ≥5 on the Kessler-6 (K6) screening scale Exclusion Criteria (Mothers): * Currently participating in another structured mental health intervention * Prior participation in SH+, or familiarity with its content * Imminent risk of suicide, assessed using the suicidality subscale of the Mini International Neuropsychiatric Interview (MINI) * Observable signs of psychosis, manic behavior, or intellectual disability that would preclude meaningful participation (as judged by trained assessors) Inclusion Criteria (Children): * Aged 3-4 years at the time of baseline enrollment * Resides with the enrolled mother in one of the selected villages in Rhino Camp * The child's mother meets all eligibility criteria and is enrolled in the trial * Provides assent Exclusion Criteria (Children): * Known cognitive impairment or developmental delay that would prevent participation in age-appropriate assessments, based on maternal report and enumerator judgment * Physical health condition that would prevent safe participation at the time of data collection

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psychological Distress

Timeframe: Baseline and 12 months post-intervention

Trial details

NCT IDNCT07062341

SponsorUppsala University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

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