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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-04-21

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Child Sexual Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual Safe Touches

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

Group Type ACTIVE_COMPARATOR

Usual Safe Touches

Intervention Type BEHAVIORAL

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

Modified Safe Touches

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

Group Type EXPERIMENTAL

Modified Safe Touches

Intervention Type BEHAVIORAL

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

Interventions

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Usual Safe Touches

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

Intervention Type BEHAVIORAL

Modified Safe Touches

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes