Sexual AssaultCOMPASSNCT02506543
Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia
A study testing COMPASS in people with Sexual Assault and Interpersonal Relations, run by Columbia University at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 13 to 19 years, women only
- Conditions the study is for
- Sexual Assault, Interpersonal Relations, Marital Status
- What is being tested?
- COMPASS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,014 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- cognitive impairment
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Being tested
- COMPASS, No intervention
- Keywords
- Adolescent Health, Ethiopia, Sexual Violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMPASSBehavioural
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 interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| COMPASS intervention | Experimental | 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. Receives: Behavioral: COMPASS |
| Wait-list control | Active comparator | No intervention Receives: Behavioral: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- International Rescue Committee, Department for International Development, United Kingdom
- Responsible party
- Principal investigator, Lindsay Stark, Columbia University
- Investigators
- Lindsay Stark, PhD, Principal investigator, Associate Professor of Population and Family Health, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506543
- Sponsor's protocol ID
- AAAP6855
- Acronym
- COMPASS
- Status last verified
- Feb 2018
- First submitted
- 19 Jul 2015
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Stark L, Asghar K, Seff I, Yu G, Tesfay Gessesse T, Ward L, Assazenew Baysa A, Neiman A, Falb KL. Preventing violence against refugee adolescent girls: findings from a cluster randomised controlled trial in Ethiopia. BMJ Glob Health. 2018 Oct 19;3(5):e000825. doi: 10.1136/bmjgh-2018-000825. eCollection 2018.
PubMed 30398223Falb 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.
PubMed 26945586
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Opportunities Through Mentoring, Parental Involvement and Safe Spaces - Ethiopia
- ClinicalTrials.gov ID
- NCT02506543
- Acronym / sponsor ID
- COMPASS / AAAP6855
- Keywords
- Adolescent Health, Ethiopia, Sexual Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,014 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- International Rescue Committee, Department for International Development, United Kingdom
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMPASS intervention | Experimental | Behavioral: COMPASSSubjects 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. |
| Wait-list control | Active comparator | Behavioral: No interventionNo intervention |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMPASSCOMPASS (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. | Behavioural | COMPASS intervention |
| No interventionWait list control group will not receive an intervention. After the follow-up study, the wait-list control group will receive the regular COMPASS program | Behavioural | Wait-list control |
Primary outcome
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
3 secondary outcomes
Change in baseline prevalence of interpersonal relationships
Time frame: 12 months
Change in baseline prevalence of physical abuse
Time frame: 12 months
Change in baseline prevalence of early marriage
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Derived from this study: PubMed 30398223Stark L, Asghar K, Seff I, Yu G, Tesfay Gessesse T, Ward L, Assazenew Baysa A, Neiman A, Falb KL. Preventing violence against refugee adolescent girls: findings from a cluster randomised controlled trial in Ethiopia. BMJ Glob Health. 2018 Oct 19;3(5):e000825. doi: 10.1136/bmjgh-2018-000825. eCollection 2018.
- Derived from this study: PubMed 26945586Falb 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Stark, PhD principal investigator
Associate Professor of Population and Family Health, Columbia University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMPASS in people with Sexual Assault and Interpersonal Relations, run by Columbia University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual violence in the past 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506543, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.