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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- 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.
- 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.
- Examine if the pathways by which RFR and HIKA improve adolescent mental health differ by sex.
- Conditions
- Mental Health Issue, Gender Equality
- 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 group | Role | What they receive |
|---|---|---|
| Rabbits for Resilience (RFR) + HIKA | Active comparator | Households 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) only | Active comparator | Households 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 only | Active comparator | Households 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.
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)
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
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
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.
- First posted10 Mar 2023
- Study start15 Mar 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- PAIDEK/Promotion de la Famille Paysanne (PFP), The Prevention Collaborative, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Nancy Glass, PhD, Principal investigator, Johns Hopkins University School of Nursing
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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathways to Improved Adolescent Mental Health Via an Economic and Gender Equality Intervention With Conflict Affected Families
- ClinicalTrials.gov ID
- NCT05763719
- Acronym / sponsor ID
- IRB00368124
- Conditions
- Mental Health Issue, Gender Equality
- Keywords
- Gender based violence, Economic empowerment, Couples intervention, Young adolescents
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,024 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- PAIDEK/Promotion de la Famille Paysanne (PFP), The Prevention Collaborative, National Institute of Mental Health (NIMH)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2023 (actual)
- 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 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)
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.
- 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.
- 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.
- Examine if the pathways by which RFR and HIKA improve adolescent mental health differ by sex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rabbits for Resilience (RFR) + HIKA | Active comparator | Behavioral: Rabbits for Resilience (RFR) + HIKAHouseholds 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. |
| Rabbits for Resilience (RFR) only | Active comparator | Behavioral: Rabbits for Resilience (RFR) onlyHouseholds 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. |
| HIKA only | Active comparator | Behavioral: HIKA Healthy Relationship ProgramHouseholds 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Rabbits for Resilience (RFR) + HIKAAlso: RFR + HIKAEconomic empowerment program using animal husbandry for young adolescents and healthy relationship program for parents/couples in same household | Behavioural | Rabbits for Resilience (RFR) + HIKA |
| Rabbits for Resilience (RFR) onlyAlso: RFR onlyEconomic empowerment program using animal husbandry with young adolescents | Behavioural | Rabbits for Resilience (RFR) only |
| HIKA Healthy Relationship ProgramAlso: HIKA onlyHealthy relationship program for parents/couples | Behavioural | HIKA only |
Primary outcome
Change in adolescent Mental Health as assessed by Kidscreen
Time frame: Baseline, 3, 6 and 12 months
Kidscreen Psychological Well-Being is on a 1 to 5 scale with higher scores representing better psychological well-being
3 secondary outcomes
Change in Adolescent Economic Empowerment assessed by 5 economic skills items
Time frame: Baseline, 3, 6, and 12 months
Change in Adolescent Food Security as assessed by the Household Food Insecurity Access Scale
Time frame: Baseline, 3, 6 and 12 months
Change in Parent Relationship and Home Life as assessed on Kidscreen
Time frame: Baseline, 3, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: 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.
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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 Glass, PhD principal investigator
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
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.