Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06388850 |
| Other study ID # |
5U01CE003393-03 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2023 |
| Est. completion date |
September 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Northeastern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
