- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04817098
Journey of Life Psychosocial Support Program
16 februari 2022 uppdaterad av: Washington University School of Medicine
Journey of Life Psychosocial Support for Conflict-Affected Populations in Uganda
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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)
Studietyp
Interventionell
Inskrivning (Faktisk)
1395
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Bweyale, Uganda
- TPO Uganda
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Kiryandongo, Uganda
- TPO Uganda
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Journey of Life Intervention Group
Community members (caregivers, teachers, and community leaders) will participate in group workshops for a period of 6 weeks.
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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.
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Övrig: Waitlist Control Group
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mental health
Tidsram: 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"
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Functioning
Tidsram: 6 months
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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.
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6 months
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Social support
Tidsram: 6 months
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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.
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6 months
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Child protection attitudes
Tidsram: 6 months
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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.
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6 months
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Parenting behaviors
Tidsram: 6 months
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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.
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6 months
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Samarbetspartners och utredare
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Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 april 2021
Primärt slutförande (Faktisk)
30 november 2021
Avslutad studie (Faktisk)
30 november 2021
Studieregistreringsdatum
Först inskickad
12 februari 2021
Först inskickad som uppfyllde QC-kriterierna
24 mars 2021
Första postat (Faktisk)
25 mars 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 februari 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 februari 2022
Senast verifierad
1 februari 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 202101122
Plan för individuella deltagardata (IPD)
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NEJ
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