- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04817098
Journey of Life Psychosocial Support Program
16. februar 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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)
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1395
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Bweyale, Uganda
- TPO Uganda
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Kiryandongo, Uganda
- TPO Uganda
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Journey of Life Intervention Group
Community members (caregivers, teachers, and community leaders) will participate in group workshops for a period of 6 weeks.
|
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.
|
|
Andet: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mental health
Tidsramme: 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"
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functioning
Tidsramme: 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.
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6 months
|
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Social support
Tidsramme: 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
|
|
Child protection attitudes
Tidsramme: 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.
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6 months
|
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Parenting behaviors
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. april 2021
Primær færdiggørelse (Faktiske)
30. november 2021
Studieafslutning (Faktiske)
30. november 2021
Datoer for studieregistrering
Først indsendt
12. februar 2021
Først indsendt, der opfyldte QC-kriterier
24. marts 2021
Først opslået (Faktiske)
25. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 202101122
Plan for individuelle deltagerdata (IPD)
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