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

Uppsala University

Status: Active, not recruiting

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

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06425523

NAK-SH/HGI-2024

2022-01573_Formas (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 904 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (mothers):

• 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

Exclusion Criteria (mothers):

• Imminent risk of suicide
• Observable signs of psychosis
• Manic behaviors
• Intellectual disability

Inclusion criteria (children):

• Age 36-59 months
• Written parental consent to enter the study
• Assent to enter the study

Exclusion criteria (children):

• Intellectual disability
• Not living with mother

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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904 participants in 3 patient groups

EUC

Active Comparator group

Description:

Enhanced Usual Care

Treatment:

Behavioral: Enhanced Usual Care (EUC)

HGI

Experimental group

Description:

Home Gardening Intervention

Treatment:

Behavioral: Home Gardening Intervention (HGI)

Behavioral: Enhanced Usual Care (EUC)

SH+/HGI

Experimental group

Description:

Self-Help Plus in combination with Home Gardening Intervention

Treatment:

Behavioral: Self-Help Plus (SH+)

Behavioral: Home Gardening Intervention (HGI)

Behavioral: Enhanced Usual Care (EUC)