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

Domestic Violence Clinical Trial

— COMPASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506543
• Other study ID #: AAAP6855
• Status: Completed
• Phase: N/A
• First received: July 19, 2015
• Last updated: February 6, 2018
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1014
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Domestic Violence
• Interpersonal Relations
• Marital Status
• Sexual Assault

Intervention

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.
• 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

Locations

Country	Name	City	State
Ethiopia	International Rescue Committee	Addis Ababa
United States	Columbia University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Department for International Development, United Kingdom, International Rescue Committee

Countries where clinical trial is conducted

United States,  Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in baseline prevalence of interpersonal relationships	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.	12 months
Secondary	Change in baseline prevalence of physical abuse	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.	12 months
Secondary	Change in baseline prevalence of early marriage	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.	12 months