PsychologicalNCT04817098
Journey of Life Psychosocial Support Program
A study testing Journey of Life in people with Psychological and Child Development, run by Washington University School of Medicine at 2 sites in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological, Child Development, Social Values
- What is being tested?
- Journey of Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,395 participants
- Where
- 2 sitesUganda
- Study dates
- 19 Apr 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Refugee living in Kiryandongo settlement
- Over the age of 18
- Caregiver for a child under age 18
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the detailed 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)
- Conditions
- Psychological, Child Development, Social Values
- Being tested
- Journey of Life
- Keywords
- Refugee, Community development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Journey of LifeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Journey of Life Intervention Group | Experimental | Community members (caregivers, teachers, and community leaders) will participate in group workshops for a period of 6 weeks. Receives: 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. Receives: Behavioral: Journey of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start19 Apr 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- TPO Uganda, United States Agency for International Development (USAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817098
- Sponsor's protocol ID
- 202101122
- Status last verified
- Feb 2022
- First submitted
- 12 Feb 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34001055
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Journey of Life Psychosocial Support for Conflict-Affected Populations in Uganda
- ClinicalTrials.gov ID
- NCT04817098
- Acronym / sponsor ID
- 202101122
- Conditions
- Psychological, Child Development, Social Values
- Keywords
- Refugee, Community development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,395 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- TPO Uganda, United States Agency for International Development (USAID)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Journey of Life Intervention Group | Experimental | Behavioral: Journey of LifeCommunity members (caregivers, teachers, and community leaders) will participate in group workshops for a period of 6 weeks. |
| Waitlist Control Group | Other | Behavioral: Journey of LifeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Refugee living in Kiryandongo settlement
- Over the age of 18
- Caregiver for a child under age 18
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Journey of LifeThe 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. | Behavioural | Journey of Life Intervention Group, Waitlist Control Group |
Primary outcome
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"
4 secondary outcomes
Functioning
Time frame: 6 months
Social support
Time frame: 6 months
Child protection attitudes
Time frame: 6 months
Parenting behaviors
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Derived from this study: PubMed 34001055Cohen 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.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Journey of Life in people with Psychological and Child Development, run by Washington University School of Medicine at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04817098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.