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
Launched by UPPSALA UNIVERSITY · Jul 2, 2025
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a group program called Self-Help Plus (SH+) can help improve the mental health of South Sudanese refugee mothers living in Rhino Camp, Uganda, and whether this also benefits their preschool-aged children. SH+ is a stress management course created by the World Health Organization to support people going through difficult times. The study wants to see if the benefits for mothers last for at least a year and if the program also helps children’s behavior, thinking skills, and overall wellbeing.
To take part, mothers need to be at least 18 years old, speak Juba Arabic, have a child aged 3 or 4 years, and experience some level of psychological distress. Mothers who are already in other mental health programs or have serious mental health risks won’t be eligible. If a mother joins, her young child can also participate if they live together and are able to take part in simple activities. Participants will be divided into groups where some mothers join the SH+ program and others do not. Researchers will check in with both groups after 12 months to see how the mothers and children are doing. This study aims to better understand how supporting mothers’ mental health might also help their children grow and thrive in tough living conditions.
Gender
FEMALE
Eligibility 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
About Uppsala University
Uppsala University, a prestigious institution located in Sweden, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive expertise in various fields of health sciences to conduct innovative studies aimed at improving patient outcomes and understanding complex diseases. With a strong emphasis on ethical standards and rigorous scientific methodologies, Uppsala University collaborates with a network of researchers, healthcare professionals, and industry partners to facilitate groundbreaking clinical trials that contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kabale, , Uganda
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported