Transforming Health and Resilience in Vulnerable Environments: Mental Health, Psychosocial Support, and Climate-Smart Farming in Nakivale

NCT06425523 | Active Not Recruiting

• 2 other identifiers: NAK-SH/HGI-20242022-01573_Formas
• Study Type: interventional
• Target: 904
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate if enhancing the mental health of refugee mothers can make them better able to implement new farming methods that are meant to improve food security in the face of climate change. It is a cluster-randomized controlled trial involving 900 pairs consisting of refugee mothers and their children aged 36-59 months, living in Nakivale refugee settlement in Uganda. The mothers will be randomly assigned to one of three groups:

• Control group: Mothers will receive Enhanced Usual Care (EUC).
• HGI group: Mothers will receive the Home Gardening Intervention, consisting of training and supplies for home gardening.
• HGI/SH+ group: Mothers will receive both the Home Gardening Intervention and the Self-Help Plus mental health intervention. The main goal is to see if the gardening program alone can reduce food insecurity after 12 months compared to the EUC control group. It also aims to see if reducing psychological distress by adding the mental health component boosts the effects of the gardening intervention. Secondary goals are to look at impacts on dietary diversity, child malnutrition, and mothers' mental health levels across all three groups. The study also gathers survey data on participant mothers' migration history, social capital, exposure to potentially traumatic events, exposure to natural hazards and environmental stressors, mental health, and parenting style. Both mothers and their children will furthermore play incentivized economic games to measure their economic preferences (time, risk, social preferences). Additionally, the study will assess children's well-being and functioning. Children will also be asked to carry out gamified tasks designed to measure their cognitive development.

Conditions

Psychological Distress; Malnutrition, Child; Dietary Deficiency; Mental Health; Malnutrition

Keywords

Self-Help Plus; Home Gardening Intervention; Uganda; Refugee; Nakivale; Mental health; Child development; Food security; Climate change adaptation; Climate smart agriculture; Farming intervention

Outcome Measures

Primary Outcomes (1)

• Food insecurity

  Food insecurity will be assessed using the Food Insecurity Experience Scale (FIES). The FIES was developed by the FAO, and consists of 8 questions regarding the availability of sufficient food in the past thirty days. The questions form a scale calibrated against a global reference from the 2014-2016 Gallup World Poll for comparability across countries. Responses are analyzed as a scale using Item Response Theory (IRT) models, ensuring comparability of food insecurity prevalence rates.

  12 months

Secondary Outcomes (3)

• Dietary diversity

  12 months

• Child malnutrition

  12 months

• Psychological distress

  12 months

Other Outcomes (14)

• Economic preferences

  12 months

• Cognitive skills

  12 months

• Social capital

  12 months

Study Arms (3)

EUC

ACTIVE COMPARATOR

Enhanced Usual Care

Behavioral: Enhanced Usual Care (EUC)

HGI

EXPERIMENTAL

Home Gardening Intervention

Behavioral: Home Gardening Intervention (HGI); Behavioral: Enhanced Usual Care (EUC)

SH+/HGI

EXPERIMENTAL

Self-Help Plus in combination with Home Gardening Intervention

Behavioral: Home Gardening Intervention (HGI); Behavioral: Self-Help Plus (SH+); Behavioral: Enhanced Usual Care (EUC)

Interventions

Home Gardening Intervention (HGI) BEHAVIORAL

The Home Gardening Intervention (HGI) provides refugee participants with agricultural inputs and training (field prep., sowing, water management, pest control, weeding, etc.) through a participatory field school approach with a curriculum derived from best practices in agro-ecology. The program includes active monitoring during a 12-month period. The training involves nutrition education on cooking methods and the importance of dietary diversity using garden produce as well as guidance on surplus management and market support. The overall goal of the intervention is to enable climate-resilient farming for improved food security and dietary diversity that is sustainable long-term.

HGI; SH+/HGI

Self-Help Plus (SH+) BEHAVIORAL

Self-Help Plus (SH+) is a 5-session group intervention developed by the WHO and based on Acceptance and Commitment Therapy, delivered by trained local facilitators. It provides tools to manage stress and adversity through pre-recorded audio lessons and a self-help book. Sessions include individual exercises and group discussions. SH+ aims to decrease psychological distress. It has shown effectiveness among refugees in Uganda and elsewhere.

SH+/HGI

Enhanced Usual Care (EUC) BEHAVIORAL

The Enhanced Usual Care (EUC) control condition involves a single 15-minute psychoeducation session providing information on managing overthinking and utilizing available mental health services in the settlement. These services include psychosocial support from community health workers and clinical mental health services (counseling and medications) provided weekly at local primary care centers by a visiting team.

EUC; HGI; SH+/HGI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psychological distress (score 5 or above on K-6)
• Ability to speak and understand Kiswahili
• Have a child aged 36-59 months
• Availability of plot of land for farming
• Access of water for farming
• Written informed consent to enter the study

You may not qualify if:

• Imminent risk of suicide
• Observable signs of psychosis
• Manic behaviors
• Intellectual disability
• Age 36-59 months
• Written parental consent to enter the study
• Assent to enter the study
• Intellectual disability
• Not living with mother

Sponsors & Collaborators

• Uppsala University: lead
• The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS): collaborator
• Vivo international e.V.: collaborator
• Bielefeld University: collaborator
• Kabale University: collaborator
• University of Turku: collaborator
• Max Planck Institute for Research on Collective Goods: collaborator
• University of North Carolina, Charlotte: collaborator

Study Sites (1)

Kabale University

Kabale, Western Region, Uganda

Location

Related Publications (3)

• Tol WA, Leku MR, Lakin DP, Carswell K, Augustinavicius J, Adaku A, Au TM, Brown FL, Bryant RA, Garcia-Moreno C, Musci RJ, Ventevogel P, White RG, van Ommeren M. Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial. Lancet Glob Health. 2020 Feb;8(2):e254-e263. doi: 10.1016/S2214-109X(19)30504-2.

  PMID: 31981556 BACKGROUND

• Al Daccache M, Abi Zeid B, Hojeij L, Baliki G, Bruck T, Ghattas H. Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings. BMC Nutr. 2024 Apr 19;10(1):60. doi: 10.1186/s40795-024-00864-8.

  PMID: 38641632 BACKGROUND

• Hall J, Ainamani HE, Vassiliou PTB, Doring S, Gredeback G, Peltonen K, Scharpf F, Sen U, Sutter M, Walsh JI, Hecker T. Combining mental health and climate-smart agricultural interventions to improve food security in humanitarian settings: study protocol for the THRIVE cluster-randomized controlled trial with mothers in Nakivale refugee settlement, Uganda. Trials. 2025 Sep 1;26(1):331. doi: 10.1186/s13063-025-09042-y.

  PMID: 40890859 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition; Psychological Well-Being

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Personal Satisfaction; Behavior

Study Officials

• Jonathan Hall, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm, parallel-group, 1:1:1 allocation, superiority, cluster-randomized controlled trial (cRCT)

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: December 13, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)