Clinical trial NCT02506543: Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia
Official title: Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
Interpersonal Relations
Marital Status
Domestic Violence
Keywords: Adolescent Health
Ethiopia
Sexual Violence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: International Rescue Committee
name: Department for International Development, United Kingdom
First posted: 2015-07-23
Enrollment: 1014
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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 three refugee camps in Ethiopia. The study design will employ a two group wait-list cluster randomized controlled trial where girls will be invited to participate in the COMPASS program, assigned to groups of approximately 20 for the purposes of the program, complete a pre-test baseline assessment, and will then be randomized by group to the intervention or control condition. In addition, qualitative research will address additional questions of acceptability, processes of change and best practice.

Groups in three refugee camps - Sherkole, Bambasi, and Tongo - will be randomized to determine whether the participants receive the intervention or are placed on the wait-list immediately following the baseline. Those that do not get the curriculum during the study will receive it following the endline phase of the study so as to not create tensions or jealousies.

The intervention, the COMPASS program, will involve a structured intervention for girls between the ages of 13-19 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.

Detailed description: The study assessment will employ a mixed methods approach with most data collection occurring at pre-test/baseline and post-intervention. 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). 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 at baseline will include focus group discussions with caregivers and participatory methods with girls to assess topics such as self-esteem, empowerment, safety, and resilience. Endline qualitative methods include in-depth interviews with caregivers, and small-group warm-up activities with adolescent girls, followed by in-depth interviews.

Eligibility criteria: Inclusion Criteria:

* female
* aged 13-19
* speak one of the languages included in the study (Sudanese Arabic, Funj/Berta, Maban, Regarig and Engesena Quickly dialects)
* 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: Columbia University
state: New York
city: Addis Ababa
country: Ethiopia
facility: International Rescue Committee
Study officials:
affiliation: Associate Professor of Population and Family Health, Columbia University
name: Lindsay Stark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stark L, Asghar K, Seff I, Yu G, Tesfay Gessesse T, Ward L, Assazenew Baysa A, Neiman A, Falb KL. Preventing violence against refugee adolescent girls: findings from a cluster randomised controlled trial in Ethiopia. BMJ Glob Health. 2018 Oct 19;3(5):e000825. doi: 10.1136/bmjgh-2018-000825. eCollection 2018.
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.