Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388850
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-29
First Post:
2024-03-20
Brief Title:
Evaluation of HRP Among Pre-K Through 5th Grade
Sponsor:
Northeastern University
Organization:
Northeastern University
Study Overview
Official Title:
Evaluation of the School-based Healthy Relationships Project for Primary Prevention of Child Sexual Abuse Among Children Pre-K Through 5th Grade
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 schoolspublic charter schools in Washington DC serving approximately 8960 or 13440 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 DCs 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 teachersfacilitators 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
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 schoolspublic charter schools in Washington DC serving approximately 8960 or 13440 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 DCs 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 teachersfacilitators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None