Clinical trial NCT05763719: Pathways to Improved Adolescent Mental Health in Conflict Affected Families
Official title: Pathways to Improved Adolescent Mental Health Via an Economic and Gender Equality Intervention With Conflict Affected Families
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Gender Equality
Keywords: Gender based violence
Economic empowerment
Couples intervention
Young adolescents
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: PAIDEK/Promotion de la Famille Paysanne (PFP)
name: The Prevention Collaborative
name: National Institute of Mental Health (NIMH)
First posted: 2023-03-10
Enrollment: 3024
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

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.
3. Examine if the pathways by which RFR and HIKA improve adolescent mental health differ by sex.

Eligibility criteria: Inclusion Criteria:

* 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

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
* 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

Primary outcomes:
measure: Change in adolescent Mental Health as assessed by Kidscreen
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Change in Adolescent Economic Empowerment assessed by 5 economic skills items
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Adolescent Food Security as assessed by the Household Food Insecurity Access Scale
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in Parent Relationship and Home Life as assessed on Kidscreen
timeFrame: Baseline, 3, 6 and 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins University School of Nursing
name: Nancy Glass, PhD
role: PRINCIPAL_INVESTIGATOR
References: