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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Child Sexual Abuse
• Intervention / Treatment: Behavioral: Usual Safe Touches; Behavioral: Modified Safe Touches

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate Guastaferro, PhD, MPH; Phone Number: 2129929032; Email: RoadstoImpactStudy@nyu.edu
• Study Contact Backup: Name: Mia Melchior, MPH; Email: m.melchior@nyu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Safe Touches; Delivered by 2 facilitators in a classroom by utilizing live puppet skits	Behavioral: Usual Safe Touches; The in-person Safe Touches workshop is delivered in the classroom by 2 facilitators with live puppet skits, as designed.
Experimental: Modified Safe Touches; Delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos	Behavioral: Modified Safe Touches; The modified Safe Touches workshop will be delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: New York University
• Investigators: Principal Investigator: Kate Guastaferro, PhD, MPH, New York University

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: prevention; school-based intervention; universal prevention; Safe Touches
• Other Study ID Numbers: R21HD110822 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No