Clinical trial NCT06195852: Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial
Official title: Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Sexual Abuse
Keywords: prevention
universal prevention
school-based intervention
Safe Touches
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Children's Knowledge of Abuse Questionnaire
timeFrame: Pre-workshop, immediately post-workshop, 1-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Weller Health Education at Lehigh Valley Health Network
state: Pennsylvania
city: Elizabethville
country: United States
facility: Northern Dauphin County YMCA
state: Pennsylvania
city: State College
country: United States
facility: Centre County (Centre Safe &amp; Youth Service Bureau)
state: Pennsylvania
city: York
country: United States
facility: York County Children&#39;s Advocacy Center
state: Pennsylvania
Study officials:
affiliation: New York University
name: Kate Guastaferro, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: