Clinical trial NCT04817098: Journey of Life Psychosocial Support Program
Official title: Journey of Life Psychosocial Support for Conflict-Affected Populations in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological
Child Development
Social Values
Keywords: Refugee
Community development
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: TPO Uganda
name: United States Agency for International Development (USAID)
First posted: 2021-03-25
Enrollment: 1395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The proposed study evaluates the impact and implementation of the Journey of Life intervention among crisis-affected caregivers living in Western Uganda. In this quasi experimental waitlist control design, participants will be assigned to treatment or waitlist control group based on their geographic location. The intervention will be delivered in X sessions weekly. Assessments will be conducted at baseline and following the intervention period. Assessments will include mental health, functioning, social support, child protection behaviors, parenting attitudes, and experiences of intimate partner violence. The study also aims to examine implementation of the Journey of Life intervention through qualitative assessments of feasibility, acceptability, adaptation, reach, and adoption.

Detailed description: Aligned with the USAID HEARD (Health Evaluation and Applied Research Development) purpose to leverage global partnerships to generate, synthesize, and use evidence to improve program implementation in low and middle-income countries, the proposed study will examine the impact and implementation of the Journey of Life (JoL) intervention in a humanitarian setting. The JoL intervention aims to provide psychosocial support to adults and galvanize caregivers to develop action plans for child protection in their communities. The proposed research will involve an analysis of effect sizes for mental health, functioning, social support, child protection behaviors, parenting attitudes and behaviors, and experiences of intimate partner violence. The research also aims to interrogate implementation strategies that are useful within humanitarian contexts through qualitative key informant interviews and focus group discussions. Assessments include baseline and follow up data collection to measure effect sizes and assess implementation strategy components. The study aims are to: (1) assess the impact of JoL on child protection indicators, (2) examine the effects of JoL on behavioral health functioning (i.e. mental health, social support, and functioning)

Eligibility criteria: Inclusion Criteria:

* Refugee living in Kiryandongo settlement
* Over the age of 18
* Caregiver for a child under age 18

Exclusion Criteria:

* Anyone aged 17 and under, unless written consent from the caregiver and assent from the participant is provided
* Anyone unable to provide consent to participate

Primary outcomes:
measure: Mental health
timeFrame: 6 months
Secondary outcomes:
measure: Functioning
timeFrame: 6 months
measure: Social support
timeFrame: 6 months
measure: Child protection attitudes
timeFrame: 6 months
measure: Parenting behaviors
timeFrame: 6 months
Other outcomes:
Locations:
city: Bweyale
country: Uganda
facility: TPO Uganda
city: Kiryandongo
country: Uganda
facility: TPO Uganda
Study officials:
References:
citation: Cohen F, Hermosilla S, Knox J, Agaba GS, Obalim G, Kajungu R, Mangen PO, Stark L. Protocol for a caregiver psychosocial support intervention for populations affected by displacement in Uganda. BMC Public Health. 2021 May 17;21(1):932. doi: 10.1186/s12889-021-10921-7.