Child Mental Health, Child Wellbeing, Mental Health, Psychological Distress
Conditions
Keywords
self-help plus, psychological distress, mental health, child development, economic preferences, cognitive development, refugee, cluster randomized controlled trial
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.
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.
Interventions
BEHAVIORALSelf-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.
BEHAVIORALEnhanced 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+.
Sponsors
Uppsala University
Vivo international e.V.
Kabale University
Bielefeld University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Distress | Baseline and 12 months post-intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key secondary outcome: Child psychosocial wellbeing (parent-report) | Baseline and 12 months post-intervention | 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. |
| Depression | Baseline and 12 months post-intervention | 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. |
| Posttraumatic Stress | Baseline and 12 months post-intervention | 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. |
| Anxiety | Baseline and 12 months post-intervention | 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. |
| Perceived Stress | Baseline and 12 months post-intervention | 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. |
| Positive Parenting | Baseline and 12 months post-intervention | Positive parenting will be measured using the Positive Parenting subscale of the Alabama Parenting Questionnaire (APQ). Higher scores indicate more frequent positive parenting practices. |
| Disciplinary Practices | Baseline and 12 months post-intervention | Harsh disciplinary practices will be ssessed using the UNICEF MICS6 11-item Discipline Module. Higher scores reflect use of more types of disciplinary actions. |
| Subjective Wellbeing | Baseline and 12 months post-intervention | 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. |
| Functional Impairment | Baseline and 12 months post-intervention | 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. |
| Psychological Flexibility | Baseline and 12 months post-intervention | 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. |
| Child Emotional and Behavioral Problems | Baseline and 12 months post-intervention | 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. |
| Child Psychosocial Wellbeing (child self-report) | Baseline and 12 months post-intervention | 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. |
Countries
Uganda
Outcome results
None listed