- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01511380
Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth
tiistai 3. toukokuuta 2016 päivittänyt: Medical University of South Carolina
This study is designed to gain knowledge about effective interventions for reducing HIV risk in a high risk population.
A new Risk Reduction Therapy for Adolescents (RRTA) will be compared to usual services received by youth in juvenile drug courts.
It is expected that youth treated with RRTA will show greater reductions in substance use and risky sexual behaviors.
Reducing HIV risk by effectively targeting substance use and risky sexual behaviors in high-risk groups such as juvenile drug court-involved youth could favorably impact society at multiple levels (individual, family, peer, community, fiscal).
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Yksityiskohtainen kuvaus
The overriding purpose of this study is to develop and test an intervention for reducing substance use and risky sexual behaviors among youth involved in juvenile drug court.
Juvenile drug court provides an excellent setting in which to pursue the key study objectives by providing access to a well identified high risk population.
Second, in addition to frequent judicial oversight, juvenile drug courts include several features that can enhance intervention effectiveness, sustainability, and potential for adoption.
In addition, the fact that all juvenile drug courts have community-based treatment components and that such courts have been disseminated nationwide suggests the possibility of eventual widespread adoption if the proposed intervention is effective.
The proposed intervention integrates evidence-based protocols for contingency management (CM) for substance abusing youth and family engagement strategies, with an evidence-informed family systems intervention for sexual risk originally developed to address substance use and sexual risk behaviors in HIV+ youth.
These three interventions will be integrated into an efficient intervention that, if effective, can be amenable to adoption by juvenile drug courts.
Following protocol development and beta testing, 160 drug court youth and their families will be randomized to the experimental intervention condition (Risk Reduction Therapy for Adolescents or "RRTA") versus Drug Court with Community Services (DC) conditions.
Key outcomes will be assessed through 18-months post-baseline using a multi-method approach that will include assessment of substance use, risky sexual behaviors, criminal behavior, and participation in HIV counseling and testing services.
Specific aims include: 1: Adapt existing intervention and training protocols into a single, efficient RRTA intervention, beta test this RRTA protocol with four youth in juvenile drug court and their families, and revise treatment and research protocols accordingly; 2: Conduct a randomized trial with 160 youth in juvenile drug court and their families to examine youth-level intervention effects (i.e., on substance use, sexual risk behavior, HIV counseling and testing, delinquent behavior) in comparison to DC through 18- months post referral and assess intervention fidelity.
3.
If results suggest a positive RRTA treatment effect, revise the intervention and training protocols in preparation for an effectiveness study and extended follow-up study.
Importantly, the proposed study will (1) consider the multiple levels of influence on juvenile drug use, criminal justice involvement, and HIV risk behaviors, (2) integrate a drug abuse and HIV prevention intervention for youth in the criminal justice system with drug-related offenses, (3) address health disparities by targeting a primarily minority population of youth, and (4) increase referrals to HIV testing and counseling of drug court-involved youth.
This study is designed to reduce HIV risk by addressing the potent interaction of drug use and risky sexual behaviors in drug court youth with evidence-based treatment components to maximize the likelihood of reversing these youths' adverse behavioral trajectories.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
120
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29401
- Medical University of South Carolina
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
12 vuotta - 17 vuotta (Lapsi)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- enrolled in juvenile drug court or pre-enrollment status
- residing with permanent caregiver
- youth and caregiver fluent in English
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Risk Reduction Therapy for Adolescents
Youth randomly assigned to RRTA will complete a family focused treatment program that will work with the youth and his or her caregiver to help reduce youth substance use and risky sexual behavior using principals of behavior modification and contingency management.
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This project integrates CM and a family systems intervention for sexual risk with evidence-based family engagement strategies, and tests this intervention in a juvenile drug court setting.
Due to the individualized nature of the proposed intervention, the specific course of treatment will vary by youth and family.
Based on our experience with clinic-based treatment models it is anticipated that most families will remain in active treatment for 4-6 months and that, during this time, they will attend approximately 1-2 sessions per week, for 1-2 hours per session.
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Active Comparator: Usual services
For youth randomly assigned to usual treatment services, the youth will receive the treatment services recommended by the drug court.
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In addition to the standard juvenile drug court requirements, youth randomly assigned to the usual services condition are also ordered to receive treatment services from the local state or privately-funded alcohol and drug treatment provider agencies.
The service delivery model for agencies typically includes intensive outpatient, traditional outpatient, and home-based services, depending upon assessment of youth and family needs.
Groups focus on risk reduction, peer influence, conflict resolution, and anger management.
Additionally, youth might receive treatment pertaining to drug selling behavior, individual sessions and/or family group therapy.
The theoretical orientations of the provider agencies are cognitive-behavioral and systems theory.
Interventions are not usually manual driven, and selection of material is typically left to the therapists' discretion.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Change in substance use frequency
Aikaikkuna: Baseline through 18 months post-baseline
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Self-reported substance use by the adolescent will be assessed using a variation of the Form 90.
Urine drug screens for cannabis, cocaine, opiates, methamphetamines, and amphetamines will be collected using the "5-Test Integrated Cup" supplied by BioTechNostix.
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Baseline through 18 months post-baseline
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Change in delinquent behavior
Aikaikkuna: Baseline through 18 months post-baseline
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The 47-item Self-Report Delinquency Scale will be used to tap violent offending, general delinquency, and status offenses.
Archival records maintained by state juvenile justice authorities will be used to examine youths' involvement in the juvenile and adult justice systems.
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Baseline through 18 months post-baseline
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Change in sexual risk behaviors
Aikaikkuna: Baseline through 18 months post-baseline
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The measure of sexual risk behaviors was selected to maximize the likelihood of identifying the highest-risk sexual behaviors.
The Sexual Risk Behavior Scale has been used in previous HIV studies.
This measure will be used to assess participant sexual encounters over the past 3 months and condom use during vaginal and anal sex.
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Baseline through 18 months post-baseline
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Change in frequency of HIV counseling and testing
Aikaikkuna: Baseline through 18 months post-baseline
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Participation in HIV counseling and testing will be assessed using a standardized set of questionnaire items.
Baseline questions will assess participants' lifetime history of voluntary HIV counseling and testing and identical questions will be re-administered at 6, 12 and 18 months post-baseline to assess whether youth received HIV counseling and testing at any point since the baseline interview.
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Baseline through 18 months post-baseline
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Maanantai 1. syyskuuta 2008
Ensisijainen valmistuminen (Todellinen)
Lauantai 1. kesäkuuta 2013
Opintojen valmistuminen (Todellinen)
Lauantai 1. kesäkuuta 2013
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 4. tammikuuta 2012
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 12. tammikuuta 2012
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 18. tammikuuta 2012
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 4. toukokuuta 2016
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 3. toukokuuta 2016
Viimeksi vahvistettu
Keskiviikko 1. toukokuuta 2013
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- R01DA025880 (Yhdysvaltain NIH-apuraha/sopimus)
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