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Trial record 1 of 1 for:    NCT02384642
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Creating Opportunities Through Mentoring, Parenting and Safe Spaces - Democratic Republic of Congo (COMPASS)

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ClinicalTrials.gov Identifier: NCT02384642
Recruitment Status : Completed
First Posted : March 10, 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 February 24, 2015
First Posted Date  ICMJE March 10, 2015
Last Update Posted Date February 8, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date November 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: March 4, 2015)
  • Change in baseline prevalence of sexual assault [ Time Frame: 12 months ]
    % reporting sexual assault in past 12 months decreases
  • Change in baseline prevalence of interpersonal relationships [ Time Frame: 12 months ]
    % reporting positive interpersonal relationships increases
  • Change in baseline prevalence of early pregnancy [ Time Frame: 12 months ]
    % reporting early pregnancy decreases
Change History Complete list of historical versions of study NCT02384642 on ClinicalTrials.gov Archive Site
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 Not Provided
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, Parenting and Safe Spaces - Democratic Republic of Congo
Official Title  ICMJE Creating Opportunities Through Mentoring, Parenting and Safe Spaces - a Randomized Controlled Trial in Democratic Republic of Congo
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.

Detailed Description

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. Research will focus on unpacking the components of the program in order to determine which components or combination of components have the most impact. This research will include a mix of qualitative and quantitative approaches to establish a foundation for good programming that supports adolescent girls' safe and healthy transition into adulthood.

The study assessment will employ a mixed methods approach with most data collection occurring at pre-test/baseline and post-intervention, although a qualitative assessment will also be performed at the intervention midpoint as a process indicator. 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) and Computer-Assisted Personal Interviewing (CAPI). 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 will include in-depth semi-structured interviews and focus group discussions with girls, their family members and mentors, as well as participatory methods with girls to assess topics such as self-esteem, empowerment, and resilience.

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 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.
  • Behavioral: COMPASS plus parenting
    The COMPASS plus parenting intervention is the core COMPASS intervention, plus activities for the parents and caregivers of participants.
Study Arms  ICMJE
  • Active Comparator: COMPASS
    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.
    Intervention: Behavioral: COMPASS
  • Experimental: COMPASS plus parenting
    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.
    Intervention: Behavioral: COMPASS plus parenting
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 29, 2015)
1633
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2015)
880
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female
  • aged 10-14
  • give informed consent

Exclusion Criteria:

- cognitive impairment

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 10 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02384642
Other Study ID Numbers  ICMJE AAAO6612
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lindsay Stark, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • International Rescue Committee
  • Department for International Development, United Kingdom
Investigators  ICMJE
Principal Investigator: Lindsay Stark Associate Professor of Population and Family Health
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