NCT02771132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,121

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

May 11, 2016

Last Update Submit

March 16, 2020

Conditions

Sexual Assault and RapeViolence, Non-accidental

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Physical Violence Incidence (WHO-Violence Against Women Survey)

    8-20 months post-intervention

Study Arms (2)

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)

Behavioral: 12-hr "IMPower" empowerment self defense courseBehavioral: 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)

Behavioral: Life-skills course

Interventions

12-hr "IMPower" empowerment self defense courseBEHAVIORAL

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.

Intervention
12-hr Source of Strength for boysBEHAVIORAL

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.

Intervention
Life-skills courseBEHAVIORAL

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.

Standard of Care

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

African Institute for Health and Development

Nairobi, Kenya

Location

Related Publications (2)

  • Mphamba 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.

    PMID: 35579915DERIVED

  • Sarnquist 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.

    PMID: 31248392DERIVED

Related Links

Study Officials

  • Michael Baiocchi, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 12, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2018

Study Completion

April 1, 2019

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

KE(1)