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Trial record 1 of 1 for:    NCT02506543
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Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia (COMPASS)

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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

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.


Condition or disease Intervention/treatment Phase
Sexual Assault Interpersonal Relations Marital Status Domestic Violence Behavioral: COMPASS Behavioral: No intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1014 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia
Study Start Date : August 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
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.
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.

Active Comparator: Wait-list control
No intervention
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506543


Locations
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United States, New York
Columbia University
New York, New York, United States, 10168
Ethiopia
International Rescue Committee
Addis Ababa, Ethiopia
Sponsors and Collaborators
Columbia University
International Rescue Committee
Department for International Development, United Kingdom
Investigators
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Principal Investigator: Lindsay Stark, PhD Associate Professor of Population and Family Health, Columbia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lindsay Stark, Associate Professor of Population and Family Health at the Colum, Dept Population&Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT02506543     History of Changes
Other Study ID Numbers: AAAP6855
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lindsay Stark, Columbia University:
Adolescent Health
Ethiopia
Sexual Violence