Integrated Treatment of Marijuana Abuse for HIV+ Youth
2. marts 2017 opdateret af: University of North Carolina, Chapel Hill
Integrated Treatment of Alcohol and/or Marijuana Abuse for HIV-Infected Youth - Phase I
This is an exploratory study that will adapt and test a combined cognitive behavioral treatment and contingency management intervention for alcohol and/or marijuana abuse for use in HIV-infected adolescents.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
46
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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Los Angeles, California, Forenede Stater, 90027
- Childrens Hospital of Los Angeles
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New York
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New York, New York, Forenede Stater, 10128
- Mount Sinai Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Childrens Hospital of Philadelphia
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 24 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adolescents between the ages of 16-24 years (inclusive) at the time of informed consent/assent as determined by medical record review or verbal verification from referring professional
- HIV-infected and aware of their status as documented by medical record review or verbal verification from referring professional
- Receives services at one of the three participating ATN clinic site or their community partners
- A score of 2 or greater on the CRAFFT indicating possible alcohol or marijuana use problem or abuse
- Alcohol and/or Marijuana Use or Abuse Disorder as indicated by the SSPQ-X
- Appropriate for an outpatient or intensive outpatient level of care in accordance with the American Academy of Child and Adolescent Psychiatry practice parameters as decided by site mental health provider in consultation with Drs. Brown and Esposito-Smythers
- English-speaking
- Ability and willingness to provide informed consent/assent for study participation
- Satisfactorily understands the nature of the study and the informed consent process as documented by the Consent Form Comprehension Assessment Questionnaire
Exclusion Criteria:
- Presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder)
- Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior)
- Intoxicated or under the influence of alcohol or other substances at the time of study entry
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 1
Focus groups with adolescents with SA (Substance Abuse) will be conducted at each site (one group with 5 to 6 adolescents per site) to provide information on the areas of the intervention in need of adaptation in order to reflect the context of HIV infection.
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Focus group using and collecting feedback on the CBT/CM intervention.
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Eksperimentel: 2
The first intervention trial will enroll 9 participants (3 participants per site).
Exit interviews of participants will assess acceptability, feasibility, and relevance of the intervention.
Quantitative assessments pre and post intervention using audio computer-assisted self-interviewing (ACASI) will document immediate changes in substance use, sexual risk, and adherence to medical care.
Additional qualitative feedback from interviews with mental health providers and study coordinators will address feasibility, acceptability, and relevance of the intervention and its methods.
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Intervention will comprise of approximately 15 weekly sessions.
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Eksperimentel: 3
The revised intervention will be implemented with 20 participants (6 to 8 at each site).
Exit interviews with subjects and feedback from mental health providers and study coordinators will provide the same qualitative information as in the first intervention trial.
Quantitative data on participant outcomes such as substance use, sexual risk, and adherence to medical care will be collected pre, post and 3 month post intervention through ACASI.
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Evaluations/assessments will be similar to those involved for the first intervention trial.
Study participants will return for a follow-up visit 3 months after the last intervention session to complete the ACASI.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To adapt a developmentally appropriate CBT/CM intervention for alcohol and/or marijuana abuse for HIV+ youth, relevant to the context of chronic medical care, emotion dysregulation due to frequent co-morbid psychiatric disorders and sexual risk behavior.
Tidsramme: 2 years
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2 years
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To evaluate the acceptability, feasibility, and effectiveness of the CBT/CM intervention for alcohol and/or marijuana abuse, adherence to medical care, emotion regulation, and safer sexual behavior.
Tidsramme: 2 years
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2 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To revise the CBT/CM intervention based on information obtained in Phase 1 (this protocol), prepare for Phase 2 (to be supported by NIH), and disseminate the treatment manual to the ATN sites.
Tidsramme: 2 years
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2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Larry K. Brown, M.D., Adolescent Trials Network
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2008
Primær færdiggørelse (Faktiske)
1. august 2010
Studieafslutning (Faktiske)
1. april 2011
Datoer for studieregistrering
Først indsendt
21. maj 2008
Først indsendt, der opfyldte QC-kriterier
22. maj 2008
Først opslået (Skøn)
23. maj 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. marts 2017
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Kognitiv adfærdsterapi
- Komplementære terapier
- Stofmisbrug
- Motiverende forstærkende terapi
- Adolescent community reinforcement approach
- Adolescent Risk Behavior Assessment
- Child and Adolescent Services Assessment
- Cognitive Therapy Rating Scale
- Individual behavior therapy
- Individual cognitive problem solving
- HIV-Positive Youth With Substance Abuse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ATN 069
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 .