- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06442046
Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE)
Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE) project will create a pathway for children and families from the City of Hartford to connect with a Connecticut Children's Care Coordinator (CC) when they are determined to have high levels of violence exposure.
SCOPE seeks to decrease future violence exposure and increase resiliency of children with high levels of exposure to violence through Emergency Department (ED)-based case management and connections with community partners.
Hypothesis 1: VPET scores within the intervention group will show significant reductions across the study period. The percent of patients with positive VPET positive scores within the intervention group will show significant reductions from the expected 79% to 70% as compared to the control group that will have the expected 79%
Hypothesis 2: The Child and Youth Resilience Measure-Revised (CYRM) scores for the intervention group will increase by 10%, and will be significantly higher than the control group.
Hypothesis 3: At least 75% of the intervention group will be assessed as "positive" for having made a connection with community services.
Hypothesis 4: 90% of parents with children receiving case management will report being satisfied with the case management services and community connected services.
Hypothesis 5: Retention within the intervention group will be at or above 50%, with at least half of participants remaining engaged in the project.
Hypothesis 6: Compared to the control group, the intervention group will have fewer documented injuries and ED visits during the 12-month period post-enrollment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sharon Smith, MD
- Phone Number: 8605459295
- Email: Srsmith@ccmckids.org
Study Contact Backup
- Name: Rebecca Beebe, PhD
- Email: RBeebe01@connecticutchildrens.org
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Recruiting
- Connecticut Children's
-
Contact:
- Sharon Smith, MD
-
Contact:
- Kevin Borrup, DrPH
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 8 years of age and not older than 17 years of age (until 18th birthday)
- Hartford resident based on zip code of primary residence or parent report?
- Accompanied by a parent or guardian who can provide consent
- Capable of providing assent/consent
- Able to provide consent in English or Spanish
- Presenting at CT Children's during recruitment hours
Exclusion Criteria:
- Patients whose primary complaint is for behavioral health
- Patients in Connecticut Department of Children and Families (DCF) or police custody
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Enrolled subjects will provide the study team with email, mobile, work phone, physical contact address, and contact numbers for two or more close contacts.
Families will be contacted monthly by the case manager assist with additional supports they might need.
Quarterly, patients and families will be contacted and patients will be asked to complete VPET and other measures.
The intervention group will receive active case management to connect affected youth to community services.
|
A case manager will work with families post-discharge to ensure that youth are connected to an appropriate community support.
Case managers will also work with families to identify any social needs and provide support in accessing services as needed.
Subjects will receive a list of youth serving community service agencies and provided a recommendation to connect to them.
|
|
Active Comparator: Treatment as Usual
The comparison group will receive treatment as usual which consists of a list of community resources and a recommendation that youth not already connected with a community service provider be connected.
|
Subjects will receive a list of youth serving community service agencies and provided a recommendation to connect to them.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline violence exposure at 12 months
Time Frame: Baseline and months 3, 6, 9, and 12
|
A reduction in exposure as measured using the Violence Prevention Emergency Tool (VPET) that provides a range from 0 to 21 with a 4 or more considered elevated.
|
Baseline and months 3, 6, 9, and 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in resilience score from baseline at 12 months
Time Frame: Baseline and months 3, 6, 9, and 12
|
The Child and Youth Resilience Measure-Revised (CYRM) is a validated scale with resilience scores that range from 17 to 85 with a higher score indicating greater resilience.
|
Baseline and months 3, 6, 9, and 12
|
|
Difference in connections between intervention and control at 3-month intervals.
Time Frame: Quarterly measure at 0, 3, 6, 9, and 12 months
|
A dichotomous yes/no variable answering the question of are you currently connected to services at a community agency?
|
Quarterly measure at 0, 3, 6, 9, and 12 months
|
|
Level of satisfaction with case management services after 12 months of services
Time Frame: At 12-months of case management.
|
Level of satisfaction with case management services as indicated along a 5-point scale from Not satisfied to Completely satisfied.
Higher levels of satisfaction are related with other improved outcomes from baseline.
|
At 12-months of case management.
|
|
Rate of re-injury in the intervention group compared to the control condition.
Time Frame: baseline, 3, 6, 9, 12 months
|
Hospital documented injuries during the study period will be assessed on a quarterly schedule.
|
baseline, 3, 6, 9, 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin Borrup, DrPH, Connecticut Children's
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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