Evaluation of HRP Among Pre-K Through 5th Grade

NCT ID: NCT06388850

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2025-09-30

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.

Detailed Description

The Healthy Relationships Project (HRP) created, modified and run by the organization Prevent Child Abuse Vermont, has been delivering CSA primary prevention curricula since 1990 with implementation across 30 U.S. States, including statewide in Vermont. During those decades, substantiated cases per year in Vermont dropped 61%, and the number of child perpetrators per year dropped 69%. Addressing Research Priority 1, implementation of the HRP in Pre-K through 5th grade will be rigorously evaluated in a mixed-methods stepped wedge randomized trial design with 16 public charter schools in three high-need wards in Washington, DC. The School Safety Omnibus Amendment Act of 2018 was enacted to obligate DC schools to prevent and address student sexual abuse. The partner organization, Safe Shores, the Child Advocacy Center (CAC) for DC, has implemented HRP in public charter schools with success; the opportunity remains to conduct this trial in schools where it has not been delivered and increase its feasibility via established trust with the district and schools. The findings about its efficacy will potentially place the HRP into the echelon of evidence-based programs that many schools seek to use, especially those mandated to deliver CSA prevention programming. Data from Safe Shores, the CAC that receives reports of suspected child abuse from all Washington, DC public schools, will be utilized as the primary outcome, including the numbers and types of CSA investigations and other services provided by the CAC involving the participating schools, which include forensic services, family advocacy, case management and more. More commonly utilized measures of improvements in protective behaviors, self-efficacy, knowledge and disclosure will be collected from caregivers and teachers. Qualitative research will be included to assess the strengths and weaknesses of intervention rollout, fidelity monitoring, lessons learned and sustainability. This innovative and novel mixed methods evaluation study will move the science of child sexual abuse prevention research forward with a community-based participatory research partnership between scientists in family violence prevention research, professionals at community-based organizations, and participating public elementary schools in high-need urban areas. In summary, a rigorous experimental evaluation of an existing universal primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data will be conducted.

Specific Aims:

Aim 1: Test the efficacy of the Healthy Relationships Program in reducing reports of child sexual abuse by implementing a stepped wedge randomized trial design. Sixteen (minimum, possibly up to 24) public schools/public charter schools in Washington D.C. serving approximately 8,960 (or 13,440 with 24 schools) urban, ethnically diverse children in grades Pre-K through 5 will transition from waitlist to active intervention condition in 6-month intervals using stratified randomization. It is hypothesized that over 1 year, rates of CSA reports from schools receiving the HRP may be lower relative to reports from schools that did not receive the HRP or may be higher given increased awareness provided by the program. These reports will be generated by data collected by Safe Shores, the Child Advocacy Center (CAC), whose multidisciplinary teams support Washington, DC's children who have been the subject of a child abuse report, as well as their families.

Aim 2: Test the efficacy of the HRP in reducing theory-based intervention mechanisms among caregivers and teachers. The investigators expect over 1 year, caregivers of children receiving the HRP and teachers/facilitators will have improved knowledge of CSA, knowledge of grooming behaviors, parental monitoring, internet safety, parent-child communication about consent, and self-efficacy for CSA protection, relative to baseline. The investigators expect over 1 year, teachers and social workers implementing the HRP curriculum, as well as caregivers of the children receiving it, will have improved CSA knowledge, self-efficacy for reporting, comfort with CSA education and prevention of CSA behaviors by children, relative to baseline. The investigators plan to measure these mechanisms via online surveys distributed to all teachers and caregivers of children in grades Pre-K through 5. The surveys will be distributed a total of 5 times to meet the requirements of the stepped wedge randomized trial design.

Aim 3: Conduct a qualitative evaluation of the sustainability of the HRP, with ongoing input from community stakeholders. The investigators will interview school and community-based stakeholders to understand the perceived capacity, buy-in, and impact of ongoing implementation of the HRP program through school-community partnerships. The investigators hypothesize that important sustainability characteristics can be identified to facilitate future dissemination efforts. These interviews will happen both before and after the implementation of the HRP at the participating schools.

Conditions

Child Sexual Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Healthy Relationships Project

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healthy Relationships Project

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Private schools
• School in non high-need wards

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northeastern University

OTHER

Sponsor Role: lead

Responsible Party

Beth Molnar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Safe Shores

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

Countries

United States

Other Identifiers

5U01CE003393-03

Identifier Type: NIH

Identifier Source: org_study_id

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