- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06442046
Styrkelse af forbindelserne til muligheder for forebyggelsesengagement (SCOPE)
Styrkelse af forbindelserne til muligheder for forebyggelsesengagement (SCOPE)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Connecticut
-
Hartford, Connecticut, Forenede Stater, 06106
- Connecticut Children's
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Aktiv komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline violence exposure at 12 months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in resilience score from baseline at 12 months
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kevin Borrup, DrPH, Connecticut Children's
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24-052
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .