NCT02384642

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,633

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

February 24, 2015

Last Update Submit

February 6, 2018

Conditions

Sexual AssaultInterpersonal RelationsMarital StatusDomestic Violence

Keywords

Adolescent HealthDemocratic Republic of CongoSexual 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

ACTIVE COMPARATOR

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.

Behavioral: COMPASS

COMPASS plus parenting

EXPERIMENTAL

In the COMPASS plus parenting intervention arm, girls will receive the COMPASS intervention, and In addition to the safe spaces for girls, the COMPASS project will also implement structured activities for the parents and caregivers of participants. 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.

Behavioral: COMPASS plus parenting

Interventions

COMPASSBEHAVIORAL

COMPASS (Creating Opportunities through Mentoring, Parental involvement and Safe Spaces) is a program for 10-14 year old girls in Eastern DRC. 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
COMPASS plus parentingBEHAVIORAL

The COMPASS plus parenting intervention is the core COMPASS intervention, plus activities for the parents and caregivers of participants.

COMPASS plus parenting

Eligibility Criteria

Age10 Years - 14 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • female
  • aged 10-14
  • give informed consent

You may not qualify if:

  • \- cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Rescue Commitee

New York, New York, 10168, United States

Location

Related Publications (4)

  • 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.

    PMID: 34582454DERIVED

  • 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.

    PMID: 30398222DERIVED

  • 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.

    PMID: 29273113DERIVED

  • 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.

    PMID: 26945586DERIVED

Study Officials

  • Lindsay Stark

    Associate Professor of Population and Family Health

    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

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 10, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

US(1)