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

Uppsala University

Status: Not yet enrolling

Conditions: Child Mental Health; Child Wellbeing; Psychological Distress; Mental Health

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07062341

P22-0514 (Other Grant/Funding Number)

Details and patient eligibility

About

This study evaluates whether the group-based mental health program Self-Help Plus (SH+) can improve the wellbeing of South Sudanese refugee mothers and their preschool-aged children living in Rhino Camp, Uganda. SH+ is a stress management course developed by the World Health Organization for people affected by adversity. A previous study in Rhino Camp 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 four 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?
• Does the SH+ program influence the socio-behavioral skills of mothers and children, including their willingness to take risks, delay rewards (patience), and share with others (prosociality)?
• Does SH+ administered to mothers improve children's cognitive development?

To answer these questions, this study will employ a cluster-randomized controlled trial. Mothers in some communities will receive the SH+ intervention, while those in other communities will not. Researchers will follow up with both groups 12 months after the intervention.

The study uses caregiver reports, direct child assessments, and incentivized economic games 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 their preschool-aged children in adverse settings.

Full description

This cluster-randomized controlled trial (cRCT) evaluates the sustained and intergenerational impacts of the WHO's Self-Help Plus (SH+) program among South Sudanese refugee mothers and their preschool-aged children in Rhino Camp Refugee Settlement, Uganda. SH+ is a low-intensity, group-based mental health intervention designed for use in humanitarian settings. It consists of five audio-guided sessions supported by a self-help book, grounded in Acceptance and Commitment Therapy, and is facilitated by trained non-specialist peers from the local refugee community.

The study enrolls 720 mother-child dyads (children aged 3-4 years at baseline) across 24 village clusters, randomized 1:1 to receive either SH+ with Enhanced Usual Care (EUC) or EUC alone. Assessments are conducted at baseline, 3 months, and 12 months post-intervention. The primary outcomes are maternal psychological distress and child psychosocial wellbeing at 12 months. Secondary outcomes include broader maternal mental health, parenting practices, child behavioral and emotional problems, and functional capacities in both mothers and children. All outcomes are measured at each assessment point, except for economic decision-making and child cognitive abilities, which are measured only at baseline and 12 months.

A unique feature of the study is its focus on economic decision-making. Incentivized behavioral tasks are used to measure core economic preferences in both mothers and children. These include patience (willingness to delay gratification), risk tolerance (willingness to engage with uncertainty in pursuit of reward), and prosociality (willingness to share or act in others' interest). These capacities are considered key to economic behavior and long-term wellbeing and are often shaped by adversity and caregiving environments.

In addition to its primary focus, the study incorporates exploratory outcomes that allow for broader insights into intergenerational wellbeing. These include measures of food security, household dietary diversity, and child nutritional status, as well as child cognitive skills, parenting behavior, and social capital. Although these outcomes are not central to the study's main hypotheses, they provide important contextual and developmental information and align with a growing body of research on adversity, development, and family functioning in humanitarian settings.

Outcomes are assessed through survey interviews, direct assessments, and age-adapted behavioral tasks. SH+ is delivered in groups of up to 30 participants, co-facilitated by trained peers from the refugee community. EUC consists of a brief psychoeducation session and referral to available mental health resources.

This trial provides one of the first rigorous tests of a scalable, group-based maternal mental health intervention's long-term and intergenerational effects on psychological wellbeing and economic preferences in a refugee setting. By including exploratory outcomes related to food security, nutrition, and child cognitive development, the study also contributes to broader discussions about resilience, caregiving, and intergenerational wellbeing under conditions of protracted displacement.

Enrollment: 720 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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720 participants in 2 patient groups

EUC

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care (EUC)

SH+EUC

Experimental group

Description:

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.

Treatment:

Behavioral: Self-Help Plus (SH+)

Behavioral: Enhanced Usual Care (EUC)