Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial

Child Sexual Abuse Clinical Trial

Official title:

Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195852
• Other study ID #: R21HD110822
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: New York University
• Contact: Kate Guastaferro, PhD, MPH
• Phone: 2129929032
• Email: RoadstoImpactStudy[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the equivalence of two delivery modalities of a universal child sexual abuse prevention program, Safe Touches: usual vs. modified. The aims are to:

1. Determine the equivalence of effectiveness between usual and modified Safe Touches

2. Assess the maintenance of gains between usual and modified Safe Touches

3. Examine factors that may impact the future dissemination and implementation

Description:

Child sexual abuse (CSA) is a public health problem affecting 1 in 5 girls and 1 in 12 boys before age 18. National estimates indicate children ages 7 to 13 are at highest risk for CSA and CSA is associated with lifelong negative sequelae. School-based prevention programs offer cost-effective universal programming teaching students an array of personal safety skills. Several programs have demonstrated effectiveness in increasing children's knowledge of self-protection, and some have been linked with facilitating disclosures, including Safe Touches. Effectiveness notwithstanding, the programmatic reach of universal school-based programs is limited by the inherent reliance on school infrastructure and a dearth of available alternative delivery modalities. The current study is designed to address this gap by leveraging an existing partnership between university-based researchers (NYU), the Safe Touches model developer (NYSPCC), and community-based organizations with active implementations of Safe Touches. The study will use a rigorous cluster randomized design to determine the equivalence of effectiveness between two delivery modalities of Safe Touches: as usual vs. modified. The usual workshop will be delivered by two facilitators with live puppet skits, as designed (N=90). Whereas, the modified workshop will be delivered by one facilitator utilizing pre recorded skit videos (N=90). The research team will determine the equivalence of concept learning acquisition (Aim 1) and retention (Aim 2) among students in classrooms that receive the as usual or modified workshop. To conclude equivalence, it is important to examine factors that may impact future dissemination and implementation, specifically program adoption among school personnel and implementation fidelity (Aim 3). Study findings will inform the ongoing development of effective CSA prevention programs and policy decisions regarding the sustainable integration of such programs within schools. Given the scope and burden of CSA, especially among elementary aged students, it is a public health priority to efficiently disseminate effective school-based prevention programs on a wide scale.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

Inclusion Criteria:

• Enrolled in a second grade classroom participating in the research

• Native English speaker

• Parental permission to participate in the research

Exclusion Criteria:

• Not enrolled in a second grade classroom participating in the research

• Non-native English speaker

• No parental permission to participate in the research

Related Conditions & MeSH terms

• Child Sexual Abuse

Intervention

Behavioral:
• Usual Safe Touches
The in-person Safe Touches workshop is delivered in the classroom by 2 facilitators with live puppet skits, as designed.
• Modified Safe Touches
The modified Safe Touches workshop will be delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Children's Knowledge of Abuse Questionnaire	6-items rated on 3- point scale (Yes, Unsure, No) where higher scores indicate a greater knowledge of safe and unsafe touches	Pre-workshop, immediately post-workshop, 3-month follow up