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Completed

NCT Number: NCT04817098

Journey of Life Psychosocial Support Program

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TPO Uganda, Bweyale, Uganda

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Journey of Life

Behavioral

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.

Primary outcomes

  1. Mental health

    Time frame: 6 months

    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"

Secondary outcomes

  1. Functioning

    Time frame: 6 months

    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.

  2. Social support

    Time frame: 6 months

    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.

  3. Child protection attitudes

    Time frame: 6 months

    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.

  4. Parenting behaviors

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • TPO Uganda
  • United States Agency for International Development (USAID)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2021
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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