Clinical trial NCT06425523: Transforming Health and Resilience in Vulnerable Environments: Mental Health, Psychosocial Support, and Climate-Smart Farming in Nakivale
Official title: Strengthening Resilience to Climate Change by Improving Mental Health: Evidence from a Randomized Intervention in Southwestern Uganda
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
name: Vivo international e.V.
name: Bielefeld University
name: Kabale University
name: University of Turku
name: Max Planck Institute for Research on Collective Goods
name: University of North Carolina, Charlotte
First posted: 2024-05-22
Enrollment: 904
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm, parallel-group, 1:1:1 allocation, superiority, cluster-randomized controlled trial (cRCT)
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Food insecurity
timeFrame: 12 months
Secondary outcomes:
measure: Dietary diversity
timeFrame: 12 months
measure: Child malnutrition
timeFrame: 12 months
measure: Psychological distress
timeFrame: 12 months
Other outcomes:
measure: Economic preferences
timeFrame: 12 months
measure: Cognitive skills
timeFrame: 12 months
measure: Social capital
timeFrame: 12 months
measure: Positive parenting
timeFrame: 12 months
measure: Maltreatment
timeFrame: 12 months
measure: Posttraumatic stress
timeFrame: 12 months
measure: Stress
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Anxiety
timeFrame: 12 months
measure: Psychological flexibility
timeFrame: 12 months
measure: Functional impairment
timeFrame: 12 months
measure: Subjective wellbeing
timeFrame: 12 months
measure: Child wellbeing and functioning
timeFrame: 12 months
measure: Child emotional and behavioral problems
timeFrame: 12 months
Locations:
city: Kabale
country: Uganda
facility: Kabale University
state: Western Region
Study officials:
affiliation: Uppsala University
name: Jonathan Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.