Sexual Assault and RapeNCT02771132
A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Adolescents in Nairobi, Kenya
A study testing 12-hr "IMPower" empowerment self defense course, 12-hr Source of Strength for boys and Life-skills course in people with Sexual Assault and Rape and Violence, Non-accidental, run by Stanford University at 1 site in Kenya.
Trial summary
The primary objective of this study is to compare the effectiveness of classroom-based behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of care intervention, on reducing the incidence of self-reported sexual assault among girls from baseline. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault and Rape, Violence, Non-accidental
- What is being tested?
- 12-hr "IMPower" empowerment self defense course, 12-hr Source of Strength for boys and Life-skills course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,121 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2015to Apr 2019
- 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents aged 11-15 years
- Enrolled in the target schools
- Able to communicate in the study languages: English or Kiswahili
Who cannot join
- significant mental condition (learning difficulty, mental illness or substance abuse) which would impair their ability to consent to participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Upper Primary School Adolescents in Nairobi, Kenya
The primary objective of this study is to compare the effectiveness of classroom-based behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of care intervention, on reducing the incidence of self-reported sexual assault among girls from baseline.
Secondary objectives of this study is to determine the impact of the interventions on related physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and self-esteem.
Read the detailed description
In Kenya, up to 46% of women report childhood sexual assault. In an implementation research project, a team at Stanford University will be pairing with three Kenyan NGO's to research the effectiveness of an intervention to prevent sexual assault among adolescent girls in the informal settlements around Nairobi, Kenya. The study design will be a cluster-randomized controlled trial with two arms comparing the intervention to a standard of care group. The intervention consists of two side-by-side behavioral and skills-based interventions, one for girls and one for boys, taught in schools. The interventions include identifying and avoiding risky situations, verbal techniques to diffuse situations, as well as bystander intervention techniques for boys and self-defense techniques for girls. Settlements with schools participating in the project include Kibera, Dandora, Huruma, and Mukuru.
This grant is part of the larger "What Works to Prevent Violence: A global program to prevent violence against women and girls" initiative, which is a large international initiative aimed at the prevention of gender-based violence. The initiative includes 18 projects from around the globe, and is supported by the Medical Research Council of South Africa, the London School of Hygiene and Tropical Medicine, and the UK Department for International Development (DFID). The primary contact people at Stanford University for this project are Clea Sarnquist, DrPH, MPH (cleas@stanford.edu) and Michael Baiocchi, PhD (baiocchi@stanford.edu).
- Conditions
- Sexual Assault and Rape, Violence, Non-accidental
- Being tested
- 12-hr "IMPower" empowerment self defense course, 12-hr Source of Strength for boys, Life-skills course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-hr "IMPower" empowerment self defense courseBehavioural
The purpose of the 12-hr "IMPower" empowerment self defense course intervention for girls is to empower then to avoid risky situations, advocate for themselves, and, if needed, defend themselves against an attack.
12-hr Source of Strength for boysBehavioural
The 12-hr Source of Strength for boys curriculum is specifically designed for 10-13 year-old boys and focused on promoting gender equality, developing positive masculinity, and teaching safe and effective bystander intervention techniques.
Life-skills courseBehavioural
A 1.5-2 hour life skills class that is based on the Kenyan Ministry of Education life skills course and includes a wide range of topics, including sexual assault but also sanitation, food safety, and personal rights. All school-aged children who attend school typically receive this type of curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 12-hour intervention "IMPower" empowerment self defense course for girls and 12-hour Source of Strength for boys+ 2 refresher sessions (at 2 hrs. per session) Receives: Behavioral: 12-hr "IMPower" empowerment self defense course; Behavioral: 12-hr Source of Strength for boys |
| Standard of Care | Other | 1-2 hour course based on Ministry of Education life skills course (no refresher sessions) Receives: Behavioral: Life-skills course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Assault Incidence (WHO-Violence Against Women Survey)
self-reports of sexual assault within past 12 months, compared between control and intervention groups
Measured: 12 months
Secondary outcomes (1)
Physical Violence Incidence (WHO-Violence Against Women Survey)
Self-reports of physical violence, compared between control and intervention groups
Measured: 8-20 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual Assault and RapeStudies of the same condition, open and under way.
- More trials run by Stanford 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
- 4,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- African Institute for Health and Development, Kenya, Medical Research Council, South Africa
- Responsible party
- Principal investigator, Mike Baiocchi, Stanford University
- Investigators
- Michael Baiocchi, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771132
- Sponsor's protocol ID
- 34706
- Status last verified
- Mar 2020
- First submitted
- 11 May 2016
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: To protect the privacy of the participants (who are minors), parties interested in the data should contact the investigators and provide evidence of IRB approval and data security safeguards at their institution(s). The sponsoring agency, DFID, anticipates making some of the data publicly available in the future.
Publications
Sarnquist C, Friedberg R, Rosenman ETR, Amuyunzu-Nyamongo M, Nyairo G, Baiocchi M. Sexual Assault Among Young Adolescents in Informal Settlements in Nairobi, Kenya: Findings from the IMPower and SOS Cluster-Randomized Controlled Trial. Prev Sci. 2024 May;25(4):578-589. doi: 10.1007/s11121-023-01595-1. Epub 2023 Nov 15.
PubMed 37966676Mphamba D, Solomon FR, Nyairo G, Kim CJ, Krishnamoorthi M, Edem B, Amuyunzu-Nyamongo M, Kang J, Baiocchi M, Sarnquist CC. Youth voices from an informal settlement of Nairobi, Kenya: Engaging adolescent perspectives on violence to inform prevention. Glob Public Health. 2022 Dec;17(12):3686-3699. doi: 10.1080/17441692.2022.2076895. Epub 2022 May 17.
PubMed 35579915Sarnquist C, Kang JL, Amuyunzu-Nyamongo M, Oguda G, Otieno D, Mboya B, Omondi N, Kipkirui D, Baiocchi M. A protocol for a cluster-randomized controlled trial testing an empowerment intervention to prevent sexual assault in upper primary school adolescents in the informal settlements of Nairobi, Kenya. BMC Public Health. 2019 Jun 27;19(1):834. doi: 10.1186/s12889-019-7154-x.
PubMed 31248392
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Upper Primary School Adolescents in Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT02771132
- Acronym / sponsor ID
- 34706
- Conditions
- Sexual Assault and Rape, Violence, Non-accidental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,121 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- African Institute for Health and Development, Kenya, Medical Research Council, South Africa
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 12 May 2016 (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 primary objective of this study is to compare the effectiveness of classroom-based behavioral interventions (12-hour girls program and 12-hour boys program), to a standard-of care intervention, on reducing the incidence of self-reported sexual assault among girls from baseline.
Secondary objectives of this study is to determine the impact of the interventions on related physical and mental health status/outcomes, STI-risk behaviors, self-efficacy, and self-esteem.
Detailed description
In Kenya, up to 46% of women report childhood sexual assault. In an implementation research project, a team at Stanford University will be pairing with three Kenyan NGO's to research the effectiveness of an intervention to prevent sexual assault among adolescent girls in the informal settlements around Nairobi, Kenya. The study design will be a cluster-randomized controlled trial with two arms comparing the intervention to a standard of care group. The intervention consists of two side-by-side behavioral and skills-based interventions, one for girls and one for boys, taught in schools. The interventions include identifying and avoiding risky situations, verbal techniques to diffuse situations, as well as bystander intervention techniques for boys and self-defense techniques for girls. Settlements with schools participating in the project include Kibera, Dandora, Huruma, and Mukuru.
This grant is part of the larger "What Works to Prevent Violence: A global program to prevent violence against women and girls" initiative, which is a large international initiative aimed at the prevention of gender-based violence. The initiative includes 18 projects from around the globe, and is supported by the Medical Research Council of South Africa, the London School of Hygiene and Tropical Medicine, and the UK Department for International Development (DFID). The primary contact people at Stanford University for this project are Clea Sarnquist, DrPH, MPH (cleas@stanford.edu) and Michael Baiocchi, PhD (baiocchi@stanford.edu).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 12-hr "IMPower" empowerment self defense course, Behavioral: 12-hr Source of Strength for boys12-hour intervention "IMPower" empowerment self defense course for girls and 12-hour Source of Strength for boys+ 2 refresher sessions (at 2 hrs. per session) |
| Standard of Care | Other | Behavioral: Life-skills course1-2 hour course based on Ministry of Education life skills course (no refresher sessions) |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Adolescents aged 11-15 years
- Enrolled in the target schools
- Able to communicate in the study languages: English or Kiswahili
Key exclusion criteria (1 listed)
- significant mental condition (learning difficulty, mental illness or substance abuse) which would impair their ability to consent to participation in the trial.
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 |
|---|---|---|
| 12-hr "IMPower" empowerment self defense courseThe purpose of the 12-hr "IMPower" empowerment self defense course intervention for girls is to empower then to avoid risky situations, advocate for themselves, and, if needed, defend themselves against an attack. | Behavioural | Intervention |
| 12-hr Source of Strength for boysThe 12-hr Source of Strength for boys curriculum is specifically designed for 10-13 year-old boys and focused on promoting gender equality, developing positive masculinity, and teaching safe and effective bystander intervention techniques. | Behavioural | Intervention |
| Life-skills courseA 1.5-2 hour life skills class that is based on the Kenyan Ministry of Education life skills course and includes a wide range of topics, including sexual assault but also sanitation, food safety, and personal rights. All school-aged children who attend school typically receive this type of curriculum. | Behavioural | Standard of Care |
Primary outcome
Sexual Assault Incidence (WHO-Violence Against Women Survey)
Time frame: 12 months
self-reports of sexual assault within past 12 months, compared between control and intervention groups
1 secondary outcome
Physical Violence Incidence (WHO-Violence Against Women Survey)
Time frame: 8-20 months post-intervention
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 18 Mar 2020.
- Derived from this study: PubMed 37966676Sarnquist C, Friedberg R, Rosenman ETR, Amuyunzu-Nyamongo M, Nyairo G, Baiocchi M. Sexual Assault Among Young Adolescents in Informal Settlements in Nairobi, Kenya: Findings from the IMPower and SOS Cluster-Randomized Controlled Trial. Prev Sci. 2024 May;25(4):578-589. doi: 10.1007/s11121-023-01595-1. Epub 2023 Nov 15.
- Derived from this study: PubMed 35579915Mphamba D, Solomon FR, Nyairo G, Kim CJ, Krishnamoorthi M, Edem B, Amuyunzu-Nyamongo M, Kang J, Baiocchi M, Sarnquist CC. Youth voices from an informal settlement of Nairobi, Kenya: Engaging adolescent perspectives on violence to inform prevention. Glob Public Health. 2022 Dec;17(12):3686-3699. doi: 10.1080/17441692.2022.2076895. Epub 2022 May 17.
- Derived from this study: PubMed 31248392Sarnquist C, Kang JL, Amuyunzu-Nyamongo M, Oguda G, Otieno D, Mboya B, Omondi N, Kipkirui D, Baiocchi M. A protocol for a cluster-randomized controlled trial testing an empowerment intervention to prevent sexual assault in upper primary school adolescents in the informal settlements of Nairobi, Kenya. BMC Public Health. 2019 Jun 27;19(1):834. doi: 10.1186/s12889-019-7154-x.
- This protocol is part of the What Works to Prevent Violence Initiative, a global program to prevent violence against women and girlsLink provided by the sponsor.
- Individual participant dataSharing planned: No. To protect the privacy of the participants (who are minors), parties interested in the data should contact the investigators and provide evidence of IRB approval and data security safeguards at their institution(s). The sponsoring agency, DFID, anticipates making some of the data publicly available in the future.
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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.
Michael Baiocchi, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-hr "IMPower" empowerment self defense course, 12-hr Source of Strength for boys and Life-skills course in people with Sexual Assault and Rape and Violence, Non-accidental, run by Stanford University at 1 site in Kenya.
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 3 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. 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 Assault Incidence (WHO-Violence Against Women Survey) (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 NCT02771132, which also lists 3 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 18 Mar 2020.