Journey of Life Psychosocial Support Program

Child Development Clinical Trial

Official title:

Journey of Life Psychosocial Support for Conflict-Affected Populations in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817098
• Other study ID #: 202101122
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1395
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Psychological
• Social Values

Intervention

Behavioral:
• Journey of Life
The concept underlying the JoL intervention is that caregivers and community members can support each other and their children through reflection, dialogue, and action. JoL addresses children's and adolescents' ecologies by working with caregivers, educators, and community members to understand the importance of their support in protecting children.

Locations

Country	Name	City	State
Uganda	TPO Uganda	Bweyale
Uganda	TPO Uganda	Kiryandongo

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	TPO Uganda, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental health	Changes in mental health symptoms according to the Kessler-6 from baseline to follow up assessments. The structure of the survey asks participants how frequently they have experienced certain symptoms in the past thirty days and presents a consistent scale of responses ranging from "1 - All of the time" to "5 - None of the time"	6 months
Secondary	Functioning	Changes in functioning according to the World Health Organization Disability Assessment Schedule (WHODAS) from baseline to follow up. The WHODAS uses a 12-item scale with a range of scores from 12 to 60, where higher scores indicate higher disability or loss of function.	6 months
Secondary	Social support	Changes in social supports according to the Medical Outcomes Study Social Supports 8-item survey from baseline to follow up. The survey is scored using an average of scores for each item and transferring them to a 0-100 score where a higher score for an individual indicates more support.	6 months
Secondary	Child protection attitudes	Changes in the adoption of positive child protective behaviors from baseline to follow-up assessments according to the adapted Child Protection Index (CPI). The CPI is a 12-item instrument that assesses attitudes towards child protection with a scoring range of 0-12 wherein a higher number indicates more permissible attitudes towards beating children.	6 months
Secondary	Parenting behaviors	Changes in the adoption of positive parenting behaviors from baseline to follow-up assessments according to the Parenting Acceptance and Rejection Questionnaire (PARQ). This 12-item subscale has a scoring range of 0-48 wherein higher scores indicate more acceptance of children.	6 months