A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Adolescents in Nairobi, Kenya

Not Applicable

Completed

• Conditions: Sexual Assault and Rape; Violence, Non-accidental
• Interventions: Behavioral: Life-skills course; Behavioral: 12-hr "IMPower" empowerment self defense course; Behavioral: 12-hr Source of Strength for boys

• Registration Number: NCT02771132
• Lead Sponsor: Stanford University

Brief 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.

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2018-09
• Study Completion: 2019-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4121

Inclusion Criteria

• Adolescents aged 11-15 years
• Enrolled in the target schools
• Able to communicate in the study languages: English or Kiswahili

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Exclusion Criteria

• significant mental condition (learning difficulty, mental illness or substance abuse) which would impair their ability to consent to participation in the trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Life-skills course	1-2 hour course based on Ministry of Education life skills course (no refresher sessions)
Intervention	12-hr "IMPower" empowerment self defense course	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)
Intervention	12-hr Source of Strength for boys	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)

Primary Outcome Measures

Name	Time	Method
Sexual Assault Incidence (WHO-Violence Against Women Survey)	12 months	self-reports of sexual assault within past 12 months, compared between control and intervention groups

Secondary Outcome Measures

Name	Time	Method
Physical Violence Incidence (WHO-Violence Against Women Survey)	8-20 months post-intervention	Self-reports of physical violence, compared between control and intervention groups

Trial Locations

Locations (1)

African Institute for Health and Development; 🇰🇪 Nairobi, Kenya