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Mental Health IssueNCT05763719

Pathways to Improved Adolescent Mental Health in Conflict Affected Families

A study testing Rabbits for Resilience (RFR) + HIKA, Rabbits for Resilience (RFR) only and HIKA Healthy Relationship Program in people with Mental Health Issue and Gender Equality, run by Johns Hopkins University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… 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 Issue, Gender Equality
What is being tested?
Rabbits for Resilience (RFR) + HIKA, Rabbits for Resilience (RFR) only and HIKA Healthy Relationship Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,024 participants
Where
1 siteUnited States
Study dates
15 Mar 2023to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins University School of Nursing

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: Pathways to Improved Adolescent Mental Health Via an Economic and Gender Equality Intervention With Conflict Affected Families

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)

Read the detailed description

In the South Kivu province of the Democratic Republic of Congo (DRC), the setting for the study, families have experienced more than two decades of conflict and trauma, displacement and political instability resulting in extreme poverty with limited educational and economic opportunities. Child poverty and exposure to trauma is widespread and particularly concentrated in conflict-affected and hard-to-reach rural areas. According to UNICEF, 80% of DRC children have experienced at least two major deprivations (e.g., absences of food, housing, water, and medical care) in the children's lifetime. Childhood exposure to multiple adversities can lead to a lifetime of poor mental health. In the investigators' previous work in rural DRC, the investigators found parent's self-report of poor mental health and victimization or perpetration of intimate partner violence (IPV) had a significant negative impact on the parents' young adolescents' mental health and functioning, with different impacts for boys and girls. Specifically, mother's experience of IPV and symptoms of PTSD and depression had a stronger negative effect on adolescent girls in the household than on adolescent boys, including experienced stigma, externalizing behaviors, and school attendance. The underlying ideologies of male authority and of girls' and women's place being in the home has led to gender norms that restrict women and girl's mobility and opportunities. The impact of inequitable social norms on young adolescent mental health has had limited attention. Bolstering young peoples' mental health in the context of compounding childhood adversities and inequitable norms requires investments in families using locally designed and led multi-level interventions. The investigators' study will combine and examine the synergistic effect of two evidence-based interventions targeting young adolescents and the adolescents' mothers and fathers. Rabbits for Resilience (RFR) is a signature economic empowerment and mentorship program by the investigators' partner Congolese led non-governmental organization (NGO), Promotion de la Famille Paysanne (PFP). Young adolescents in RFR (with parent agreement) receive two rabbits and repay this asset loan with 2 offspring; these offspring are then provided as new assets to other youth in the same village, thus a sustainable program that also strengthens peer and family relationships. Adolescents and the adolescents' parents are mentored by RFR to continue to breed rabbits after repayment to sell or use to meet basic household needs (e.g. school fees, food), respond to economic shocks (e.g. illness) or opportunities (buy a goat). The investigators' randomized controlled trial demonstrated that adolescents in families active in RFR had improved mental health, enhanced food security and better school attendance.12 Harmful norms and behaviors, including a "husband's right to use violence to discipline his wife" have sustained inequalities and in the investigators' work influences who benefits most (boys or girls) from the RFR intervention. Therefore, RFR will be combined with HIKA meaning "to arrive". HIKA is an adapted 22 week group based, gender-equality curriculum delivered to couples/parents by trained local leaders. The HIKA program strengthens family relations through knowledge and skills building in communication, power sharing, parenting, and conflict management. Couples participating in the program in Rwanda reported less physical and/or sexual violence victimization and perpetration over a 24-month period. Additional benefits included reductions in acceptability of wife beating, conflict with partner, corporal punishment, depression and improved communication, self-efficacy and self-rated health. Combining a youth-friendly economic empowerment program with a gender equality program with parents of these young adolescents will advance knowledge on the combined and synergistic impact of structural interventions and pathways for improved adolescent mental health. The investigators' multidisciplinary team will conduct a clustered randomized controlled trial with three arms (RFR only, HIKA only, RFR + HIKA) with young adolescents ages 10-14 years and the adolescents' parents living in 1080 rural households in 30 villages in two rural conflict-affected territories of South Kivu province of Eastern DRC.

  1. Examine the combined and synergetic effect of RFR and HIKA on young adolescent mental health. Hypothesis 1. Adolescents in RFR + HIKA households will report greater improvement in mental health compared to adolescents in RFR only and HIKA only households in rural conflict affected villages.
  2. Examine the pathways through which RFR and HIKA improves adolescent mental health.
  • Hypothesis 2a. Adolescents in the RFR + HIKA and RFR households will report greater improvement in mental health via pathway of improved self-efficacy, school attendance, food security and peer relationships compared to adolescents in HIKA only households in rural conflict-affected villages.
  • Hypothesis 2b. Adolescents in RFR + HIKA and HIKA only households will report greater improvement in mental health via the pathway of improved parental (mother and father) relationship quality and power sharing, reduced exposure to IPV/corporal punishment, improved parental mental health and support of gender equitable norms compared to adolescents in RFR only households in rural conflict affected villages.
  1. Examine if the pathways by which RFR and HIKA improve adolescent mental health differ by sex.
Being tested
Rabbits for Resilience (RFR) + HIKA, Rabbits for Resilience (RFR) only, HIKA Healthy Relationship Program
Keywords
Gender based violence, Economic empowerment, Couples intervention, Young adolescents

What participants receive

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

  • Rabbits for Resilience (RFR) + HIKABehavioural

    Also called RFR + HIKA

    Economic empowerment program using animal husbandry for young adolescents and healthy relationship program for parents/couples in same household

  • Rabbits for Resilience (RFR) onlyBehavioural

    Also called RFR only

    Economic empowerment program using animal husbandry with young adolescents

  • HIKA Healthy Relationship ProgramBehavioural

    Also called HIKA only

    Healthy relationship program for parents/couples

Study groups in NCT05763719
Study groupRoleWhat they receive
Rabbits for Resilience (RFR) + HIKAActive 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.
Receives: Behavioral: Rabbits for Resilience (RFR) + HIKA
Rabbits for Resilience (RFR) onlyActive 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.
Receives: Behavioral: Rabbits for Resilience (RFR) only
HIKA onlyActive 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.
Receives: Behavioral: HIKA Healthy Relationship Program

What is being measured

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

  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

    Measured: Baseline, 3, 6 and 12 months

Secondary outcomes (3)
  1. Change in Adolescent Economic Empowerment assessed by 5 economic skills items

    is on a 1 to 5 scale with higher scores representing greater economic empowerment

    Measured: Baseline, 3, 6, and 12 months

  2. Change in Adolescent Food Security as assessed by the Household Food Insecurity Access Scale

    Household Food Insecurity Access Scale is on a 1 to 4 with higher scores representing greater food insecurity

    Measured: Baseline, 3, 6 and 12 months

  3. Change in Parent Relationship and Home Life as assessed on Kidscreen

    Kidscreen Psychological Well-Being is on a 1 to 5 scale with higher scores representing better relationships

    Measured: Baseline, 3, 6 and 12 months

Timeline

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

  1. First posted10 Mar 2023
  2. Study start15 Mar 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,024 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763719
Sponsor's protocol ID
IRB00368124
Other IDs
5R01MH128913-02
Status last verified
Jul 2026
First submitted
28 Feb 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Rabbits for Resilience (RFR) + HIKA, Rabbits for Resilience (RFR) only and HIKA Healthy Relationship Program in people with Mental Health Issue and Gender Equality, run by Johns Hopkins University at 1 site in United States.

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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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 adolescent Mental Health as assessed by Kidscreen (time frame: Baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Jul 2026.

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