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

New York University (NYU)

Status: Terminated

Conditions: Child Sexual Abuse

Treatments: Behavioral: Usual Safe Touches; Behavioral: Modified Safe Touches

Study type: Interventional

Funder types: Other

Identifiers

NCT06195852

R21HD110822

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Usual Safe Touches

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Safe Touches

Modified Safe Touches

Experimental group

Description:

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

Treatment:

Behavioral: Modified Safe Touches