Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia (COMPASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02506543
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
International Rescue Committee
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Lindsay Stark, Columbia University

Tracking Information
First Submitted Date  ICMJE July 19, 2015
First Posted Date  ICMJE July 23, 2015
Last Update Posted Date February 8, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
Sexual violence in the past 12 months [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • Change in baseline prevalence of sexual assault [ Time Frame: 12 months ]
    This study will use a questionnaire to measure whether the percentage of girls who self-reported unwilling sex within the past 12 months decreases between the pre-test and post-test evaluation.
  • Change in baseline prevalence of physical abuse [ Time Frame: 12 months ]
    This study will use a questionnaire to measure whether the percentage of girls who self-reported experiencing beatings within the past 12 months decreases between the pre-test and post-test evaluation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
  • Change in baseline prevalence of interpersonal relationships [ Time Frame: 12 months ]
    This study will use a questionnaire to measure whether there is an increase in study participants' average number close friends from the pre-test to post-test evaluation. Girls will also self-report sources of emotional support such as comfort in discussing problems with a trusted female adult and comfort discussing topics such as education, marriage, puberty, pregnancy prevention, HIV/AIDS, and financial plans with caregivers.
  • Change in baseline prevalence of physical abuse [ Time Frame: 12 months ]
    This study will use a questionnaire to measure whether the percentage of girls who self-reported experiencing beatings within the past 12 months decreases between the pre-test and post-test evaluation.
  • Change in baseline prevalence of early marriage [ Time Frame: 12 months ]
    This study will use a questionnaire to measure changes in the percentage of girls who self-reported being married from the pre-test to post-test evaluation.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2015)
  • Change in baseline prevalence of interpersonal relationships [ Time Frame: 12 months ]
    This study will use a questionnaire to measure whether there is an increase in study participants' average number close friends from the pre-test to post-test evaluation. Girls will also self-report sources of emotional support such as comfort in discussing problems with a trusted female adult and comfort discussing topics such as education, marriage, puberty, pregnancy prevention, HIV/AIDS, and financial plans with caregivers.
  • Change in baseline prevalence of early marriage [ Time Frame: 12 months ]
    This study will use a questionnaire to measure changes in the percentage of girls who self-reported being married from the pre-test to post-test evaluation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia
Official Title  ICMJE Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Sexual Assault
  • Interpersonal Relations
  • Marital Status
  • Domestic Violence
Intervention  ICMJE
  • Behavioral: COMPASS
    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.
  • Behavioral: No intervention
    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
Study Arms  ICMJE
  • Experimental: COMPASS intervention
    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.
    Intervention: Behavioral: COMPASS
  • Active Comparator: Wait-list control
    No intervention
    Intervention: Behavioral: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2016)
1014
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2015)
880
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ethiopia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02506543
Other Study ID Numbers  ICMJE AAAP6855
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Lindsay Stark, Columbia University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Columbia University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • International Rescue Committee
  • Department for International Development, United Kingdom
Investigators  ICMJE
Principal Investigator: Lindsay Stark, PhD Associate Professor of Population and Family Health, Columbia University
PRS Account Columbia University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP