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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
725
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.
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+.
Kabale University
Kabale, Uganda
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.
Time frame: Baseline and 12 months post-intervention
Key secondary outcome: Child psychosocial wellbeing (parent-report)
Child psychosocial wellbeing is assessed using the Kiddy-KINDL Parent Version, a validated 24-item caregiver-reported instrument designed to capture health-related quality of life in children aged 3-6 years. Each item is scored on a 5-point Likert scale, and scores are transformed to a total score ranging from 0 to 100, with higher scores indicating better wellbeing. The outcome represents the change in mean Kiddy-KINDL scores from baseline to 12 months post-intervention, based on maternal reports collected by trained enumerators in the caregiver's preferred language.
Time frame: Baseline and 12 months post-intervention
Depression
Mothers' depressive symptoms are assessed using the 9-item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Change from baseline to 12 months is measured through self-report.
Time frame: Baseline and 12 months post-intervention
Posttraumatic Stress
Mothers' posttraumatic stress will be assessed using the PTSD Checklist - Civilian Version (PCL-C). Scores range from 6 to 30, with higher scores indicating more severe PTSD symptoms.
Time frame: Baseline and 12 months post-intervention
Anxiety
Mothers' anxiety symptoms are assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Scores range from 0 to 21, with higher scores indicating more severe anxiety.
Time frame: Baseline and 12 months post-intervention
Perceived Stress
Mothers' perceived stress is assessed using the 4-item Perceived Stress Scale (PSS-4). Total scores range from 0 to 16, with higher scores reflecting greater perceived stress.
Time frame: Baseline and 12 months post-intervention
Positive Parenting
Positive parenting will be measured using the Positive Parenting subscale of the Alabama Parenting Questionnaire (APQ). Higher scores indicate more frequent positive parenting practices.
Time frame: Baseline and 12 months post-intervention
Disciplinary Practices
Harsh disciplinary practices will be ssessed using the UNICEF MICS6 11-item Discipline Module. Higher scores reflect use of more types of disciplinary actions.
Time frame: Baseline and 12 months post-intervention
Subjective Wellbeing
Mothers' subjective wellbeing is assessed using the 5-item World Health Organization Well-Being Index (WHO-5). It contains five questions that assess positive mood, vitality, and general interests. The responses are scored on a scale from 0 (at no time) to 5 (all of the time), and the total score is then multiplied by 4 to give a score range from 0 to 100, with higher scores indicating greater wellbeing.
Time frame: Baseline and 12 months post-intervention
Functional Impairment
Mothers' functional impairment is assessed using the 15-item WHO Disability Assessment Schedule (WHODAS-II). Scores reflect levels of functional impairment across several domains. Higher scores indicate greater impairment.
Time frame: Baseline and 12 months post-intervention
Psychological Flexibility
Mothers' psychological flexibility will be measured using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Scores range from 7 to 49, with higher scores reflecting greater psychological inflexibility.
Time frame: Baseline and 12 months post-intervention
Child Emotional and Behavioral Problems
Children's emotional and behavioral problems will be assessed using the 17-item Pediatric Symptom Checklist (PSC-17), completed by caregivers. Total scores range from 0 to 34, with higher scores indicating more psychosocial difficulties.
Time frame: Baseline and 12 months post-intervention
Child Psychosocial Wellbeing (child self-report)
Children's psychosocial wellbeing will also be assessed using the self-report version of the Kiddy-KINDL. Scores range from 0 to 100, with higher scores indicating better psychosocial wellbeing.
Time frame: Baseline and 12 months post-intervention
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