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 (SEED)

Uppsala University

Status: Active, not recruiting

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 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.

Full 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.

Enrollment: 725 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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725 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)