RFR + HIKA for Adolescent Mental Health Issues

Overseen By Nancy Glass, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Moving, No adolescent, No consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

3024 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Do I need to stop my current medications to join the trial?

The trial information does not specify whether participants need to stop taking their current medications.

How is the RFR + HIKA treatment for adolescent mental health issues different from other treatments?

The RFR + HIKA treatment is unique because it combines the Healthy Relationship Program with Rabbits for Resilience, focusing on building resilience and healthy relationships, which is different from traditional therapies that may not emphasize these aspects. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment HIKA Healthy Relationship Program, Rabbits for Resilience (RFR) + HIKA, and Rabbits for Resilience (RFR) only for adolescent mental health issues?

Research shows that focusing on strengths in mental health treatment can improve well-being and increase the likelihood of successful outcomes in youth. Additionally, multicomponent programs, like those used in day hospitals, have been effective in reducing depression and improving functioning in adolescents. ^{6 7 8 9 10}

Who Is on the Research Team?

Nancy Glass, PhD

Principal Investigator

Johns Hopkins University School of Nursing

Are You a Good Fit for This Trial?

This trial is for families with an adolescent aged 10-14, living in specific villages of South Kivu province, DRC. The whole family must consent to join programs on economic empowerment and gender equality, plan to stay in the village for 18 months, and have both parents or guardians living together.

Inclusion Criteria

Parents/guardians (mother and father) consent to participate in 22 week couple curriculum

Resident in household located in one of 30 villages in 2 territories in South Kivu province in Eastern DRC

I have a child aged 10-14 living with me.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in Rabbits for Resilience (RFR) and/or HIKA programs. RFR involves training and mentorship in rabbit husbandry, while HIKA is a 22-week gender equality curriculum for parents.

22 weeks

Weekly sessions for HIKA, ongoing mentorship for RFR

Follow-up

Participants are monitored for changes in mental health, economic empowerment, and food security.

12 months

Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• HIKA Healthy Relationship Program
• Rabbits for Resilience (RFR) + HIKA
• Rabbits for Resilience (RFR) only

Trial Overview The study tests a combination of 'Rabbits for Resilience', an economic program using animal husbandry, with 'HIKA', a gender equality curriculum. Families are randomly placed into three groups: one gets RFR only, another HIKA only, and the last group receives both RFR + HIKA.

How Is the Trial Designed?

Group I: Rabbits for Resilience (RFR) + HIKA Active Control 1 Intervention

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.

Group II: Rabbits for Resilience (RFR) only Active Control 1 Intervention

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.

Group III: HIKA only Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

PAIDEK/Promotion de la Famille Paysanne (PFP)

Collaborator

Trials

1

Recruited

3,000+

The Prevention Collaborative

Collaborator

Trials

1

Recruited

3,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Greater Focus on Strengths is Associated with Successful Discharge in Youth Public Mental Health Treatment. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Use of a routine mental health measure in an adolescent secure unit. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

What nonpharmacological therapeutic interventions are provided to adolescents admitted to general mental health inpatient units? A descriptive review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Interventions for Adolescent Mental Health: An Overview of Systematic Reviews. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Multicomponent Treatment in a Day Hospital for Adolescents: A Case of Good Practice. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Community-based rehabilitation programme for adolescents with mental health conditions in Israel: a qualitative study protocol. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Single-session interventions for adolescent anxiety and depression symptoms in Kenya: A cluster-randomized controlled trial. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Integrated Programs for Early Recognition of Severe Mental Disorders: Recommendations From an Italian Multicenter Project. [2020]

9. England pubmed.ncbi.nlm.nih.gov

School-based, two-arm, parallel, controlled trial of a culturally adapted resilience intervention to improve adolescent mental health in Vietnam: study protocol. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a multicomponent, group psychological intervention for adolescents with psychosocial distress in public schools of Pakistan: a feasibility cluster randomized controlled trial (cRCT). [2022]