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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT02771132
Collaborator
African Institute for Health and Development, Kenya (Other), Medical Research Council, South Africa (Other)
4,121
1
2
43
95.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: 12-hr "IMPower" empowerment self defense course
  • Behavioral: 12-hr Source of Strength for boys
  • Behavioral: Life-skills course
N/A

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

Study Type:
Interventional
Actual Enrollment :
4121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Cluster-randomized Trial to Assess a Sexual Assault Prevention Intervention in Upper Primary School Adolescents in Nairobi, Kenya
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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)

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.

Behavioral: 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.

Other: Standard of Care

1-2 hour course based on Ministry of Education life skills course (no refresher sessions)

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Physical Violence Incidence (WHO-Violence Against Women Survey) [8-20 months post-intervention]

    Self-reports of physical violence, compared between control and intervention groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 African Institute for Health and Development Nairobi Kenya

Sponsors and Collaborators

  • Stanford University
  • African Institute for Health and Development, Kenya
  • Medical Research Council, South Africa

Investigators

  • Principal Investigator: Michael Baiocchi, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mike Baiocchi, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier:
NCT02771132
Other Study ID Numbers:
  • 34706
First Posted:
May 12, 2016
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Mar 18, 2020