Clinical trial NCT02384642: Creating Opportunities Through Mentoring, Parenting and Safe Spaces - Democratic Republic of Congo
Official title: Creating Opportunities Through Mentoring, Parenting and Safe Spaces - a Randomized Controlled Trial in Democratic Republic of Congo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
Interpersonal Relations
Marital Status
Domestic Violence
Keywords: Adolescent Health
Democratic Republic of Congo
Sexual Violence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: International Rescue Committee
name: Department for International Development, United Kingdom
First posted: 2015-03-10
Enrollment: 1633
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a randomized controlled trial of COMPASS, an intervention for adolescent girls in Eastern Democratic Republic of Congo. The study design will employ a two-arm randomized controlled trial where girls will be enrolled at the same time and randomized to receive a basic package of services, which includes life skills education and access to mentors in safe spaces, or the basic package plus a structured parenting intervention for girls' caregivers. An experimental design will be used to evaluate the relative impact of the parenting initiative in addition to the safe space program for girls. In addition, qualitative research will address additional questions of acceptability, processes of change and best practice.

Groups in North and South Kivu will be randomized so that every group is randomly designated as a group that will either roll out the core intervention or the intervention plus caregiver component. Groups that do not receive the parental intervention during the study will receive the intervention when the study is complete to reduce communal jealousies.

The intervention, the COMPASS program, will involve a structured intervention for girls between the ages of 10-14 that is intended to engage adolescent girls, those who are influential in their lives, service providers and other stakeholders, with the ultimate goal of co-creating environments in which girls are valued and safe. The program is centered on establishing or supporting community-supported safe spaces for girls where they can come and gather among themselves and participate in a structured life-skills curriculum. In addition to the safe spaces for girls, the COMPASS project will also implement structured activities for the parents and caregivers of participants.

Detailed description: The study will examine the relative impact of the parenting initiative in addition to the program for adolescent girls. The study will seek to determine whether the structured intervention with girls' parents has an added impact on outcomes improve girls' safety and well-being. Research will focus on unpacking the components of the program in order to determine which components or combination of components have the most impact. This research will include a mix of qualitative and quantitative approaches to establish a foundation for good programming that supports adolescent girls' safe and healthy transition into adulthood.

The study assessment will employ a mixed methods approach with most data collection occurring at pre-test/baseline and post-intervention, although a qualitative assessment will also be performed at the intervention midpoint as a process indicator. Quantitative survey methods will be used to evaluate attitudes towards a host of topics related to physical and financial assets and health-related behaviors. Survey questions will be administered using Audio Computer Assisted Self-Interviewing (ACASI) and Computer-Assisted Personal Interviewing (CAPI). Quantitative methods will be used to yield statistical measures of the scale of changes in attitudes, skills, and behaviors due to the intervention.

Qualitative methods will include in-depth semi-structured interviews and focus group discussions with girls, their family members and mentors, as well as participatory methods with girls to assess topics such as self-esteem, empowerment, and resilience.

Eligibility criteria: Inclusion Criteria:

* female
* aged 10-14
* give informed consent

Exclusion Criteria:

- cognitive impairment

Primary outcomes:
measure: Sexual violence in the past 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change in baseline prevalence of interpersonal relationships
timeFrame: 12 months
measure: Change in baseline prevalence of physical abuse
timeFrame: 12 months
measure: Change in baseline prevalence of early marriage
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: International Rescue Commitee
state: New York
Study officials:
affiliation: Associate Professor of Population and Family Health
name: Lindsay Stark
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seff I, Falb K, Yu G, Landis D, Stark L. Gender-equitable caregiver attitudes and education and safety of adolescent girls in South Kivu, DRC: A secondary analysis from a randomized controlled trial. PLoS Med. 2021 Sep 28;18(9):e1003619. doi: 10.1371/journal.pmed.1003619. eCollection 2021 Sep.
citation: Stark L, Seff I, Asghar K, Roth D, Bakamore T, MacRae M, Fanton D'Andon C, Falb KL. Building caregivers' emotional, parental and social support skills to prevent violence against adolescent girls: findings from a cluster randomised controlled trial in Democratic Republic of Congo. BMJ Glob Health. 2018 Oct 19;3(5):e000824. doi: 10.1136/bmjgh-2018-000824. eCollection 2018.
citation: Stark L, Seff I, Assezenew A, Eoomkham J, Falb K, Ssewamala FM. Effects of a Social Empowerment Intervention on Economic Vulnerability for Adolescent Refugee Girls in Ethiopia. J Adolesc Health. 2018 Jan;62(1S):S15-S20. doi: 10.1016/j.jadohealth.2017.06.014.
citation: Falb KL, Tanner S, Ward L, Erksine D, Noble E, Assazenew A, Bakomere T, Graybill E, Lowry C, Mallinga P, Neiman A, Poulton C, Robinette K, Sommer M, Stark L. Creating opportunities through mentorship, parental involvement, and safe spaces (COMPASS) program: multi-country study protocol to protect girls from violence in humanitarian settings. BMC Public Health. 2016 Mar 5;16:231. doi: 10.1186/s12889-016-2894-3.