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

Violence, Non-accidental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771132
• Other study ID #: 34706
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 2019

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4121
• Est. completion date: April 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• Adolescents aged 11-15 years

• Enrolled in the target schools

• Able to communicate in the study languages: English or Kiswahili

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Sexual Assault and Rape
• Violence, Non-accidental

Intervention

Behavioral:
• 12-hr "IMPower" empowerment self defense course
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 boys
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 course
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.

Locations

Country	Name	City	State
Kenya	African Institute for Health and Development	Nairobi

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	African Institute for Health and Development, Kenya, Medical Research Council, South Africa

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Assault Incidence (WHO-Violence Against Women Survey)	self-reports of sexual assault within past 12 months, compared between control and intervention groups	12 months
Secondary	Physical Violence Incidence (WHO-Violence Against Women Survey)	Self-reports of physical violence, compared between control and intervention groups	8-20 months post-intervention

External Links

•   This protocol is part of the What Works to Prevent Violence Initiative, a global program to prevent violence against women and girls