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

NCT06195852 | Terminated DMC

• 1 other identifier: R21HD110822
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

Brief 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. 1.Determine the equivalence of effectiveness between usual and modified Safe Touches
2. 2.Assess the maintenance of gains between usual and modified Safe Touches
3. 3.Examine factors that may impact the future dissemination and implementation

Conditions

Child Sexual Abuse

Keywords

prevention; universal prevention; school-based intervention; Safe Touches

Outcome Measures

Primary Outcomes (1)

• 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, 1-month follow up

Study Arms (2)

Usual Safe Touches

ACTIVE COMPARATOR

Delivered by 2 facilitators in a classroom by utilizing live puppet skits

Behavioral: Usual Safe Touches

Modified Safe Touches

EXPERIMENTAL

Delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos

Behavioral: Modified Safe Touches

Interventions

Usual Safe Touches BEHAVIORAL

The in-person Safe Touches workshop is delivered in the classroom by 2 facilitators with live puppet skits, as designed.

Usual Safe Touches

Modified Safe Touches BEHAVIORAL

The modified Safe Touches workshop will be delivered by 1 facilitator in the classroom by utilizing prerecorded workshop skit videos.

Modified Safe Touches

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled in a second grade classroom participating in the research
• Native English speaker
• Parental permission to participate in the research

You may not qualify if:

• Not enrolled in a second grade classroom participating in the research
• Non-native English speaker
• No parental permission to participate in the research

Sponsors & Collaborators

• New York University: lead

Study Sites (4)

Weller Health Education at Lehigh Valley Health Network

Allentown, Pennsylvania, 18104, United States

Location

Northern Dauphin County YMCA

Elizabethville, Pennsylvania, 17023, United States

Location

Centre County (Centre Safe & Youth Service Bureau)

State College, Pennsylvania, 16803, United States

Location

York County Children's Advocacy Center

York, Pennsylvania, 17403, United States

Location

Related Publications (1)

• Guastaferro K, Melchior MS, Heng S, Trudeau J, Holloway JL. Maximizing the reach of universal child sexual abuse prevention: Protocol for an equivalence trial. Contemp Clin Trials Commun. 2024 Jul 31;41:101345. doi: 10.1016/j.conctc.2024.101345. eCollection 2024 Oct.

  PMID: 39188413 DERIVED

Study Officials

• Kate Guastaferro, PhD, MPH

  New York 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: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 8, 2024
• Study Start: September 1, 2024
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)