NCT02506543

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,014

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

July 19, 2015

Last Update Submit

February 6, 2018

Conditions

Keywords

Adolescent HealthEthiopiaSexual Violence

Outcome Measures

Primary Outcomes (1)

  • Sexual violence in the past 12 months

    A binary composite representing any form of sexual violence in the previous 12 months, which included self-reported forced sex, unwanted sexual touching, or coerced sex

    12 months

Secondary Outcomes (3)

  • Change in baseline prevalence of interpersonal relationships

    12 months

  • Change in baseline prevalence of physical abuse

    12 months

  • Change in baseline prevalence of early marriage

    12 months

Study Arms (2)

COMPASS intervention

EXPERIMENTAL

Subjects in this group will be pre-tested at the same time with the subjects in the Wait-list control group. Subjects in this group will receive the intervention immediately after the initial pre-test/baseline assessment, which includes life skills education, access to mentors in safe spaces, and a structured parenting intervention for girls' caregivers. Then, the subjects in this group have completed the intervention (at 12-months post-intervention initiation), the subjects in this group will take the post-test at the same time with the subjects in the Wait-list control group.

Behavioral: COMPASS

Wait-list control

ACTIVE COMPARATOR

No intervention

Behavioral: No intervention

Interventions

COMPASSBEHAVIORAL

COMPASS (Creating Opportunities through Mentoring, Parental involvement and Safe Spaces) is a program for 13-19 year old girls in three refugee camps in Ethiopia. The program is a structured intervention that is intended to engage adolescent girls, through life skills training and 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.

COMPASS intervention
No interventionBEHAVIORAL

Wait list control group will not receive an intervention. After the follow-up study, the wait-list control group will receive the regular COMPASS program

Wait-list control

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University

New York, New York, 10168, United States

Location

International Rescue Committee

Addis Ababa, Ethiopia

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Lindsay Stark, PhD

    Associate Professor of Population and Family Health, Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Population and Family Health at the Colum, Dept Population&Family Health

Study Record Dates

First Submitted

July 19, 2015

First Posted

July 23, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations