Pathways to Improved Adolescent Mental Health in Conflict Affected Families
2 other identifiers
interventional
3,024
1 country
1
Brief Summary
The study combined a youth-friendly economic empowerment program (Rabbits for Resilience (RFR) with a gender equality couple curriculum program (HIKA) to advance knowledge on the combined and synergistic impact of structural interventions and pathways with families for improved adolescent mental health in resource-poor communities. The investigators' multidisciplinary team will conduct a randomized controlled trial with three arms (RFR only, HIKA only, RFR + HIKA) with young adolescents ages 10-14 years and the adolescents' mothers and fathers living in 1080 rural households in 30 villages in two rural conflict-affected territories of South Kivu province of Eastern Democratic Republic of Congo (DRC)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
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 28, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 20, 2026
April 1, 2026
3.3 years
February 28, 2023
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in adolescent Mental Health as assessed by Kidscreen
Kidscreen Psychological Well-Being is on a 1 to 5 scale with higher scores representing better psychological well-being
Baseline, 3, 6 and 12 months
Secondary Outcomes (3)
Change in Adolescent Economic Empowerment assessed by 5 economic skills items
Baseline, 3, 6, and 12 months
Change in Adolescent Food Security as assessed by the Household Food Insecurity Access Scale
Baseline, 3, 6 and 12 months
Change in Parent Relationship and Home Life as assessed on Kidscreen
Baseline, 3, 6 and 12 months
Study Arms (3)
Rabbits for Resilience (RFR) + HIKA
ACTIVE COMPARATORHouseholds randomly selected for RFR + HIKA will consent to one adolescent (age 10-14 years) to participate in RFR, a youth led animal husbandry economic empowerment intervention, where each youth is provided training and mentorship on raising rabbits. Once the adolescent builds the rabbit cage, the adolescent receives a loan of 2 rabbits to raise and breed, once the rabbit produces offspring, the adolescent repays the rabbit loan with 2 rabbits, one to repay the loan and one to repay the interest on the loan. The original rabbits and the remaining offspring are then for the adolescents to continue to raise, breed, sell, or eat with mentorship from the RFR team and other family members. Parents (mother and father) will consent to complete a 22 week couple's curriculum to increase gender equality (e.g. shared decision making, improved communication and reduced partner violence). The curriculum is delivered for 3 hours weekly by trained facilitators with 12 couples per group.
Rabbits for Resilience (RFR) only
ACTIVE COMPARATORHouseholds randomly selected for RFR only will consent to one adolescent (age 10-14 years) to participate in RFR, a youth led animal husbandry economic empowerment intervention, where each youth is provided training and mentorship on raising rabbits. Once the adolescent builds the rabbit cage, the adolescent receives a loan of 2 rabbits to raise and breed, once the rabbit produces offspring, the adolescent repays the rabbit loan with 2 rabbits, one to repay the loan and one to repay the interest on the loan. The original rabbits and the remaining offspring are then for the adolescents to continue to raise, breed, sell, or eat with mentorship from the RFR team and other family members.
HIKA only
ACTIVE COMPARATORHouseholds randomly selected for HIKA, parents (mother and father) will consent to complete a 22 week couple's curriculum to increase gender equality (e.g. shared decision making, improved communication and reduced partner violence). The curriculum is delivered for 3 hours weekly by trained facilitators with 12 couples per group.
Interventions
Economic empowerment program using animal husbandry with young adolescents
Healthy relationship program for parents/couples
Economic empowerment program using animal husbandry for young adolescents and healthy relationship program for parents/couples in same household
Eligibility Criteria
You may qualify if:
- Resident in household located in one of 30 villages in 2 territories in South Kivu province in Eastern DRC
- One adolescent (boy or girl) age 10-14 years living in household
- Mother and father (parents or guardians) of eligible adolescent living in same household
- Family plans to remain residents in the village for next 18 months
- Parents/guardians (mother and father) consent to participate in 22 week couple curriculum
- Adolescent consents to participate in animal husbandry economic empowerment program
You may not qualify if:
- Household members planning to move or leave the study village in next 18 months
- Household does not have a boy or girl age 10-14 years living in it
- Mother and/or father (parents or guardians) are not living in the household
- Parents/guardian do not consent to participate in 22 week couple curriculum
- Adolescent does not consent to participate in the animal husbandry economic empowerment program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- PAIDEK/Promotion de la Famille Paysanne (PFP)collaborator
- The Prevention Collaborativecollaborator
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Glass, PhD
Johns Hopkins University School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2023
First Posted
March 10, 2023
Study Start
March 15, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The baseline data will be deposited in the NDA by July 1, 2023 (approximately 4 months after data collection). Thereafter, scientific data will be deposited on January 1 and July 1 (standard NDA dates). NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
- Access Criteria
- Data will be findable for the research community through the NDA Collection established for this study. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in finding. The investigators will include that DOI in relevant publications.
Demographic, behavioral and clinical data will be collected using two (Adult and Adolescent) preprogrammed surveys using the secure Redcap platform based and managed by Johns Hopkins University. A planned 1080 male and female adolescents ages 10-14 will provide data across 4 time points (baseline, 3, 6 and 12 months post baseline). Demographic, behavioral and clinical data will be collected from 1080 couples/parents (1080 male/fathers and 1080 female/mothers) across 4 time points (baseline, 3, 6, and 12 months). Therefore, demographic, behavioral and clinical data will be collected from a total of 3,240 adults and adolescents over 12 months. All data will be de-identified prior to receipt in the repository, but the information needed to generate a global unique identifier for National Institute of Mental Health (NIMH) Data Archiver (NDA) will be collected for each study participant.