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

NCT07062341 | Active Not Recruiting

• 1 other identifier: P22-0514
• Study Type: interventional
• Target: 725
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health; Psychological Distress; Child Wellbeing; Child Mental Health

Keywords

self-help plus; psychological distress; mental health; child development; economic preferences; cognitive development; refugee; cluster randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Psychological Distress

  Mothers' psychological distress is assessed using the Kessler Psychological Distress Scale (K6), a 6-item self-report questionnaire that captures symptoms of anxiety and depression experienced in the past 30 days. Each item is scored from 0 (none of the time) to 4 (all of the time), yielding a total score ranging from 0 to 24. Higher scores indicate greater psychological distress. The outcome reflects the change in mean K6 scores from baseline to 12 months post-intervention.

  Baseline and 12 months post-intervention

Secondary Outcomes (12)

• Key secondary outcome: Child psychosocial wellbeing (parent-report)

  Baseline and 12 months post-intervention

• Depression

  Baseline and 12 months post-intervention

• Posttraumatic Stress

  Baseline and 12 months post-intervention

• Anxiety

  Baseline and 12 months post-intervention

• Perceived Stress

  Baseline and 12 months post-intervention

Other Outcomes (11)

• Patience (mothers)

  Baseline and 12 months post-intervention

• Risk Tolerance (mothers)

  Baseline and 12 months post-intervention

• Prosociality (mothers)

  Baseline and 12 months post-intervention

Study Arms (2)

EUC

ACTIVE COMPARATOR

Participants in this arm receive a brief, individual psychoeducation session lasting approximately 15 minutes, delivered by a trained lay provider under the supervision of a clinical psychologist. The session provides simple information on managing stress and rumination (locally referred to as "overthinking"), a prevalent concern in the refugee population. Participants are also informed about available mental health services within Rhino Camp, including community-based support structures and referral pathways to professional care. The EUC condition is designed to offer minimal, non-specialist mental health support while serving as a credible comparator for the SH+ intervention.

Behavioral: Enhanced Usual Care (EUC)

SH+EUC

EXPERIMENTAL

Participating mothers in this arm receive the full SH+ intervention in addition to Enhanced Usual Care. SH+ is a low-intensity, group-based stress management program developed by the World Health Organization. It is delivered over five sessions using pre-recorded audio content and a locally adapted illustrated guidebook, facilitated by trained non-specialists from the refugee community. The intervention aims to improve psychological wellbeing by teaching acceptance, mindfulness, and value-based action. As in the EUC arm, participants also receive a brief psychoeducation session and information about available mental health services.

Behavioral: Self-Help Plus (SH+); Behavioral: Enhanced Usual Care (EUC)

Interventions

Self-Help Plus (SH+) BEHAVIORAL

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.

SH+EUC

Enhanced Usual Care (EUC) BEHAVIORAL

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+.

EUC; SH+EUC

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women who are the primary caregivers of a preschool-aged child are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• Uppsala University: lead
• Vivo international e.V.: collaborator
• Kabale University: collaborator
• Bielefeld University: collaborator

Study Sites (1)

Kabale University

Kabale, Uganda

Location

Related Publications (2)

• Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2.

  PMID: 31981556 BACKGROUND

• Vassiliou PTB, Ainamani HE, Doring S, Gredeback G, Leku MR, Peltonen K, Scharpf F, Sen U, Sutter M, Walsh JI, Hecker T, Hall J. 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. 2026 Feb 17;27(1):173. doi: 10.1186/s13063-026-09546-1.

  PMID: 41699624 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)