- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01770873
A Multi-Center Randomized Controlled Trial of Mentoring to Prevent Youth Violence (TC2)
Take Charge 2- A Multi-Center Randomized Trial of Mentoring to Prevent Youth Violence: Incorporating New Communication and Information Technology
Studieoversikt
Detaljert beskrivelse
Violent injury is a major cause of morbidity and mortality among adolescents. The presence of a positive adult role model is a well-established protective factor against violence and other maladaptive outcomes among youth. Big Brothers Big Sisters (BBBS) is the largest U.S. mentoring organization with proven effectiveness in improving youth outcomes. However, these programs may be less effective with youth who already are exhibiting involvement in problem behavior at the time of program referral. Take Charge!, a mentor- and professional-implemented intervention with 10-15 year old assault-injured youth, showed promise for improving perceived self efficacy for avoiding violence and for decreasing aggression and problem behavior.
The overall goal of the proposed project is to develop, implement, and evaluate a research-informed youth development program that adapts the BBBS model to work for assault-injured youth. The aims are:
- To expand and refine Take Charge! and integrate it with BBBS practices;
- To conduct a randomized, controlled trial in which assault-injured 10-15 year old youth recruited from emergency departments in Baltimore and D.C. receive either standard emergency department follow-up care or the Take Charge! 2 intervention with assessment of violence-related, mental health, and educational outcomes;
- To conduct a comprehensive process evaluation of Take Charge! 2;
- And to accurately measure the costs of the intervention and assess cost-effectiveness.
Youth violence is a major cause of morbidity and mortality with marked disparities by race/ethnicity and socioeconomic status. This study is a critical next step in translating evidence-based research to real-world settings and practice.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Treatment for an assault injury in the emergency room
- English speaking (parent and youth)
Exclusion Criteria:
- Treatment for child abuse, sexual abuse, sibling fights, or police fights
- Severe psychopathology
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Take Charge 2
Receipt of BBBS mentoring plus youth and parent violence prevention curriculum
|
Youth assigned to the intervention receive a Big Brothers, Big Sisters (BBBS) mentor.
During the match process, BBBS staff provide 3 session on violence prevention for the youth's parents.
Six months into the mentoring relationship, mentors provide 6 sessions on violence prevention for the youth.
|
|
Ingen inngripen: Control
Standard emergency room protocol followed
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fighting
Tidsramme: Past 30 days
|
Have you been in a physical fight in the past 30 days?
|
Past 30 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tina L Cheng, MD, Johns Hopkins University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- NA_00075613
- TC2-2P20 (Annen identifikator: Other)
- 2P20MD000198-11 (U.S. NIH-stipend/kontrakt)
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