Evaluation of HRP Among Pre-K Through 5th Grade

NCT06388850 | Enrolling By Invitation

• 1 other identifier: 5U01CE003393-03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data.

Conditions

Child Sexual Abuse

Outcome Measures

Primary Outcomes (1)

• Reports of child sexual abuse

  The number and proportion of child sexual abuse reports per school, per grade, to a Child Advocacy Center (CAC) in Washington, DC will be shared with the investigators bi-monthly and will serve as the primary outcome to test the efficacy of the HRP in prevention of incidence of CSA.

  Every month, over 2 years

Secondary Outcomes (7)

• The Parental Knowledge Scale (PKS)

  Every 6 months, over 2 years

• The Parental Discussions about Sex Abuse Scale (PDSAS)

  Every 6 months, over 2 years

• The adapted Parenting Self Agency (PSAM)

  Every 6 months, over 2 years

• The Parent Knowledge Questionnaire (PKQ)

  Every 6 months, over 2 years

• HRP evaluation

  Every 6 months, over 2 years

Study Arms (2)

Intervention Group

EXPERIMENTAL

Schools receiving HRP programming in pre-k through 5th-grade classrooms.

Behavioral: Healthy Relationships Project

Control Group

NO INTERVENTION

Schools that have not received HRP programming. Schools in the control group will continue their normal standard of care for CSA prevention.

Interventions

Healthy Relationships Project BEHAVIORAL

The Healthy Relationships Project (HRP), created by the community-based organization Prevent Child Abuse Vermont (PCAVT), will be the focus of this rigorous evaluation study. The program is fully manualized with a widely accepted curriculum designed for Pre-K to 2nd graders (Care for Kids) and 3rd to 6th graders (We Care Elementary, though implementation will stop at 5th grade for this study). The HRP uses an upstream universal public health approach for the primary prevention of child and youth perpetration of child sexual abuse with developmentally appropriate intervention elements for children, faculty and staff at their schools, and for their caregivers.

Intervention Group

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Public schools/public charter schools in high-need wards of Washington D.C.
• Enrolling children in pre-k through 5th grade

You may not qualify if:

• Private schools
• School in non high-need wards

Sponsors & Collaborators

• Northeastern University: lead

Study Sites (1)

Safe Shores

Washington D.C., District of Columbia, 20001, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A stepped wedge cluster randomized clinical trial design will be used to assess the efficacy of two linked curricula of the Healthy Relationships Project (HRP): Care for Kids (Pre-K through 2nd Grade) and We Care Elementary (3rd through 5th Grade). The HRP includes a 1.5 hour training for school staff prior to implementation, six 30-minute classroom lessons delivered to students once per week for 6 weeks, and 3 caregiver workshops.

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 29, 2024
• Study Start: March 23, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)