Youth and Adult Microfinance to Improve Resilience Outcomes in Democratic Republic of Congo
Primary Purpose
Mental Health Disorders
Status
Completed
Phase
Not Applicable
Locations
Congo
Study Type
Interventional
Intervention
adult microfinance
Youth microfinance only
youth and adult micro finance
Sponsored by
About this trial
This is an interventional other trial for Mental Health Disorders focused on measuring Health, Youth, Microfinance
Eligibility Criteria
Inclusion Criteria:
- girls/boys (ages 10-15 years) and women/men head of households (ages 16 years and older)
- Resident in participating 10 village in Walungu Territory in Democratic Republic of Congo
Exclusion Criteria:
- girls/boys under 10 years of age
Sites / Locations
- PAIDEK, Congo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Youth microfinance only
youth and adult micro finance
adult microfinance
Arm Description
Youth receive loan
youth and adult receive loan
adults receive loan
Outcomes
Primary Outcome Measures
Change in baseline Mental health distress at 18 months
The outcome will be collected from multiple sources: 1) one randomly selected program eligible youth; and 2) one parent/caregiver in participating household
Secondary Outcome Measures
Full Information
NCT ID
NCT02008695
First Posted
October 7, 2013
Last Updated
August 12, 2019
Sponsor
Johns Hopkins University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02008695
Brief Title
Youth and Adult Microfinance to Improve Resilience Outcomes in Democratic Republic of Congo
Official Title
Youth and Adult Microfinance to Improve Resilience Outcomes in Democratic Republic of Congo
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
May 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will test the effectiveness of a youth-led animal husbandry microfinance program, Rabbits for Resilience, combined with the adult microfinance, Pigs for Peace (PFP), program on youth, family and community resilience outcomes. The following aims will be completed over the five-year longitudinal, mixed-method, cluster randomized community trial:
Specific Aim 1: Determine the relative effectiveness of a youth-led microfinance combined with the adult microfinance on youth and family resilience outcomes (reduced mental health distress, increased economic stability, improved family functioning) compared to a youth-led microfinance only and adult microfinance only approaches.
The investigators hypothesize that at six, twelve and 18-months post-baseline youth and adults in households in the youth-led and adult microfinance approach will report improved individual and family resilience outcomes compared to households in the youth-led microfinance only and adult microfinance only approaches.
Specific Aim 2: Determine the relative effectiveness of a youth-led microfinance combined with PFP microfinance on community resilience (e.g. social capital and participation in community groups by youth and adults) compared to youth-led microfinance only and adult microfinance only approaches.
The investigators hypothesize that at 18-months post baseline in households in the youth-led and adult microfinance will report improved community resilience compared to households in the youth-led microfinance only and adult microfinance only approaches
Specific Aim 3: Determine if changes in youth resilience (caregiving ability, empathy and outlook for the future) mediate the relationship between youth engagement in microfinance and outcomes, as measured by reduced mental health distress, improved family functioning and improved social capital.
Specific Aim 4: Examine youth perspectives on resilience in the context of multiple adversities (war, poverty, loss of family, displacement, victimization). Youth participants (N=50, ages 10-15 years) will be invited (with parent/caregiver consent) to complete at baseline and 18 month post-baseline qualitative interview/group discussion to examine individual, family and community resilience and what that participants perceive as key to buffering the negative health and social consequences of prolonged conflict and other adversities.
Detailed Description
Congolese youth, families and communities have survived the 16 years of conflict and are now faced with significant challenges for rebuilding participants' futures. Developing, implementing and evaluating microfinance programs that combine youth and adults is an innovative strategy to assist households and community efforts by focusing on existing strengths. The study will advance knowledge for youth, families and communities impacted by armed conflicts in six critical areas:
1) increase the investigators' knowledge of youth and adult resilience (mental and physical health, family functioning, social capital) in context of multiple adversities;
2) measurement of resilience from a social ecological and longitudinal, mixed-method perspective;
3) expand investigators' understanding of resilience to develop prevention interventions for youth in early adolescence (ages 10-15 years), an important time to develop healthy transitions to young adulthood (ages 15-10 years);
4) test a youth-led microfinance program combined with an existing and successful adult microfinance program, Pigs For Peace (PFP), that is sustainable and appropriate to the context of a war-affected population;
5) detail resources and infrastructure needed for conducting research in challenging field settings with diverse cultures and languages as well as with limited resources, such as access to mental health professionals;
6) provide guidelines for the ethical conduct of research in settings where participants of diverse ages and backgrounds may have limited knowledge of human rights and ethical research concepts, such as informed consent and assent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorders
Keywords
Health, Youth, Microfinance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
988 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Youth microfinance only
Arm Type
Active Comparator
Arm Description
Youth receive loan
Arm Title
youth and adult micro finance
Arm Type
Active Comparator
Arm Description
youth and adult receive loan
Arm Title
adult microfinance
Arm Type
Active Comparator
Arm Description
adults receive loan
Intervention Type
Behavioral
Intervention Name(s)
adult microfinance
Intervention Description
Female piglet provided to household member. Participants agrees to repay participants' "loan" by giving two piglets (one to repay the loan and one for the interest on the loan) to the association from the first litter of piglets (on average 6-12 piglets). These piglets are then given to other village member households
Intervention Type
Behavioral
Intervention Name(s)
Youth microfinance only
Intervention Description
One child (10-15 years) receive rabbits loan. The child is mentored by microfinance and community mentors. The child repays the loan to program and other children in the family and community are provided a loan from the repayment.
Intervention Type
Behavioral
Intervention Name(s)
youth and adult micro finance
Intervention Description
One child and adult member of household receive animal loan. The child and adult are mentored and repayment of the loan to the program is provided and the repayment animal is provided to other members of the community
Primary Outcome Measure Information:
Title
Change in baseline Mental health distress at 18 months
Description
The outcome will be collected from multiple sources: 1) one randomly selected program eligible youth; and 2) one parent/caregiver in participating household
Time Frame
Baseline to 18 months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
girls/boys (ages 10-15 years) and women/men head of households (ages 16 years and older)
Resident in participating 10 village in Walungu Territory in Democratic Republic of Congo
Exclusion Criteria:
girls/boys under 10 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy E Glass, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PAIDEK, Congo
City
Bukavu
ZIP/Postal Code
2375
Country
Congo
12. IPD Sharing Statement
Citations:
PubMed Identifier
32019539
Citation
Glass N, Remy MM, Mayo-Wilson LJ, Kohli A, Sommer M, Turner R, Perrin N. Comparative effectiveness of an economic empowerment program on adolescent economic assets, education and health in a humanitarian setting. BMC Public Health. 2020 Feb 4;20(1):170. doi: 10.1186/s12889-020-8219-6.
Results Reference
derived
PubMed Identifier
28292764
Citation
Kohli A, Perrin NA, Remy MM, Alfred MB, Arsene KB, Nadine MB, Heri BJ, Clovis MM, Glass N. Adult and adolescent livestock productive asset transfer programmes to improve mental health, economic stability and family and community relationships in rural South Kivu Province, Democratic Republic of Congo: a protocol of a randomised controlled trial. BMJ Open. 2017 Mar 14;7(3):e013612. doi: 10.1136/bmjopen-2016-013612.
Results Reference
derived
Learn more about this trial
Youth and Adult Microfinance to Improve Resilience Outcomes in Democratic Republic of Congo
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