Clinical trial NCT06388850: Evaluation of HRP Among Pre-K Through 5th Grade
Official title: Evaluation of the School-based Healthy Relationships Project for Primary Prevention of Child Sexual Abuse Among Children Pre-K Through 5th Grade
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Child Sexual Abuse
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Reports of child sexual abuse
timeFrame: Every month, over 2 years
Secondary outcomes:
measure: The Parental Knowledge Scale (PKS)
timeFrame: Every 6 months, over 2 years
measure: The Parental Discussions about Sex Abuse Scale (PDSAS)
timeFrame: Every 6 months, over 2 years
measure: The adapted Parenting Self Agency (PSAM)
timeFrame: Every 6 months, over 2 years
measure: The Parent Knowledge Questionnaire (PKQ)
timeFrame: Every 6 months, over 2 years
measure: HRP evaluation
timeFrame: Every 6 months, over 2 years
measure: The CSA Myths Scale
timeFrame: Every 6 months, over 2 years
measure: The Teachers' Reporting Attitudes Scale for Child Sexual Abuse (TRAS-CSA)
timeFrame: Every 6 months, over 2 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Safe Shores
state: District of Columbia
Study officials:
References: