Strengthening the Connections to Opportunities for Prevention Engagement

Interpersonal Violence Clinical Trial

— SCOPE  

Official title:

Strengthening the Connections to Opportunities for Prevention Engagement (SCOPE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442046
• Other study ID #: 24-052
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Connecticut Children's Medical Center
• Contact: Sharon Smith, MD
• Phone: 8605459295
• Email: Srsmith[@]ccmckids.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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) in an effort to reduce levels of violence exposure.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Interpersonal Violence

Intervention

Other:
• Active Case Management
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.
• Treatment as usual
Subjects will receive a list of youth serving community service agencies and provided a recommendation to connect to them.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kevin Borrup	The Tow Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline violence exposure at 12 months	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	Change in resilience score from baseline at 12 months	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
Secondary	Difference in connections between intervention and control at 3-month intervals.	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
Secondary	Level of satisfaction with case management services after 12 months of services	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.
Secondary	Difference in reported injuries between the intervention and control condition.	Hospital documented injuries during the study period will be assessed on a quarterly schedule.	baseline, 3, 6, 9, 12 months