NCT04817098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,395

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 12, 2021

Last Update Submit

February 16, 2022

Conditions

PsychologicalChild DevelopmentSocial Values

Keywords

RefugeeCommunity development

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Functioning

    6 months

  • Social support

    6 months

  • Child protection attitudes

    6 months

  • Parenting behaviors

    6 months

Study Arms (2)

Journey of Life Intervention Group

EXPERIMENTAL

Community members (caregivers, teachers, and community leaders) will participate in group workshops for a period of 6 weeks.

Behavioral: Journey of Life

Waitlist Control Group

OTHER

The waitlist control group will not receive the intervention during the first 6 months of implementation in order to assess the effects of the intervention compared to the control group. However, following intervention completion in the experimental group, the control group will receive 6 months of the intervention.

Behavioral: Journey of Life

Interventions

Journey of LifeBEHAVIORAL

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.

Journey of Life Intervention GroupWaitlist Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TPO Uganda

Bweyale, Uganda

Location

TPO Uganda

Kiryandongo, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 34001055DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

March 25, 2021

Study Start

April 19, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

UG(2)