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CompletedNCT02008695Updated Aug 14, 2019

Youth and Adult Microfinance to Improve Resilience Outcomes in Democratic Republic of Congo

An interventional study of adult microfinance and Youth microfinance only in Mental Health Disorders, sponsored by Johns Hopkins University. Completed at 1 site in Congo. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
988
Allocation
Non-randomized
Ages
10 Years and older
Sex
All
01

Study 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.

Read the 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;
    1. measurement of resilience from a social ecological and longitudinal, mixed-method perspective;
    1. 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);
    1. 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;
    1. 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;
    1. 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.
02

Conditions studied

  • Mental Health Disorders

Keywords

  • Health
  • Youth
  • Microfinance
03

In context

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • girls/boys under 10 years of age
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
988 participants (actual)

Study arms

  • Active comparator
    Youth microfinance only

    Youth receive loan

    Behavioral: adult microfinance

  • Active comparator
    youth and adult micro finance

    youth and adult receive loan

    Behavioral: Youth microfinance only

  • Active comparator
    adult microfinance

    adults receive loan

    Behavioral: youth and adult micro finance

Interventions

  • Behavioraladult microfinance

    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

  • BehavioralYouth microfinance only

    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.

  • Behavioralyouth and adult micro finance

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline to 18 months post baseline

07

Study locations

1 site
  • PAIDEK, Congo
    Bukavu, 2375, Congo
08

References and documents

Publications

  • 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. PubMed 32019539 ↗
  • 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. PubMed 28292764 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of May 2018 and a completion of May 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2013
First posted
Dec 11, 2013
Start
Aug 2012
Primary completionActual
May 23, 2018
CompletionActual
May 23, 2018
Last update
Aug 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02008695
Lead sponsor
Johns Hopkins University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Dec 11, 2013
Start date
Aug 2012
Primary completion
May 23, 2018
Completion
May 23, 2018
Last update
Aug 14, 2019

Study contacts

Nancy E Glass, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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