Mental Health DisordersNCT02008695

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

A study testing adult microfinance, Youth microfinance only and youth and adult micro finance in people with Mental Health Disorders, run by Johns Hopkins University at 1 site in Republic of the Congo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for: Mental Health Disorders
What is being tested?: adult microfinance, Youth microfinance only and youth and adult micro finance
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 988 participants
Where: 1 siteRepublic of the Congo
Study dates: Aug 2012to 23 May 2018
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 10 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

girls/boys under 10 years of age

Trial locations and contacts

1 site in 1 country.

Republic of the Congo1 site

PAIDEK, Congo
Bukavu, 2375

Other trials in Republic of the Congo

About this study

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;
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.

Conditions: Mental Health Disorders
Being tested: adult microfinance, Youth microfinance only, youth and adult micro finance
Keywords: Health, Youth, Microfinance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

adult microfinanceBehavioural
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 onlyBehavioural
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 financeBehavioural
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

Study groups in NCT02008695
Study group	Role	What they receive
Youth microfinance only	Active comparator	Youth receive loan Receives: Behavioral: adult microfinance
youth and adult micro finance	Active comparator	youth and adult receive loan Receives: Behavioral: Youth microfinance only
adult microfinance	Active comparator	adults receive loan Receives: Behavioral: youth and adult micro finance

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline to 18 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201223 May 2018

First posted11 Dec 2013 (estimated)
Study startAug 2012
Primary completion23 May 2018
Study completion23 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Mental Health DisordersStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe 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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 988 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02008695
Sponsor's protocol ID: NA_00067820
Other IDs: R01HD071958
Status last verified: Aug 2019
First submitted: 7 Oct 2013
Last updated: 14 Aug 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Youth and Adult Microfinance to Improve Resilience Outcomes in Democratic Republic of Congo
ClinicalTrials.gov ID: NCT02008695
Acronym / sponsor ID: NA_00067820
Conditions: Mental Health Disorders
Keywords: Health, Youth, Microfinance
Study type: Interventional
Recruitment status: Completed
Enrolment: 988 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Aug 2012
Primary completion: 23 May 2018 (actual)
Study completion: 23 May 2018 (actual)
First posted: 11 Dec 2013 (estimated)
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 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.

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

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Youth microfinance only	Active comparator	Behavioral: adult microfinanceYouth receive loan
youth and adult micro finance	Active comparator	Behavioral: Youth microfinance onlyyouth and adult receive loan
adult microfinance	Active comparator	Behavioral: youth and adult micro financeadults receive loan

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

girls/boys under 10 years of age

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
adult microfinanceFemale 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	Behavioural	Youth microfinance only
Youth microfinance onlyOne 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.	Behavioural	youth and adult micro finance
youth and adult micro financeOne 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	Behavioural	adult microfinance

Primary outcome

Change in baseline Mental health distress at 18 months
Time frame: Baseline to 18 months post baseline
The outcome will be collected from multiple sources: 1) one randomly selected program eligible youth; and 2) one parent/caregiver in participating household

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 14 Aug 2019.
Derived from this study: PubMed 32019539Glass 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.
Derived from this study: PubMed 28292764Kohli 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.

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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.

Nancy E Glass, PhD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 1 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Republic of the Congo. 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?

Change in baseline Mental health distress at 18 months (time frame: Baseline to 18 months post baseline). 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 NCT02008695, which also lists 2 linked publications.

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 14 Aug 2019.