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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02008695
Other study ID # NA_00067820
Secondary ID R01HD071958
Status Completed
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date May 23, 2018

Study information

Verified date August 2019
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 988
Est. completion date May 23, 2018
Est. primary completion date May 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
adult 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
Youth 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.
youth 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

Locations

Country Name City State
Congo PAIDEK, Congo Bukavu

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Congo, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline to 18 months post baseline
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