Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females

25. september 2014 opdateret af: Danielle Parrish, University of Houston
This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with master's level mental health professionals within a juvenile justice setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The overall objective of this study is to assess the feasibility and promise of an adapted CHOICES preconception intervention (CHOICES-TEEN) in reducing the risk of HIV, nicotine-exposed pregnancy (NEP), and alcohol-exposed pregnancy (AEP) in adolescent females on intensive community probation. The current study posits that a two-session CHOICES intervention adapted to target multiple bundled health risks-AEP, NEP, and HIV-will be feasible, acceptable, and promising in reducing these risks among females on community-based juvenile probation. This study will: Aim 1: Modify the efficacious CHOICES preconception intervention to target the prevention of HIV, AEP, and NEP. The result will be a two session individual intervention (CHOICES-TEEN) and accompanying therapy manual based on the Transtheoretical Model (TTM) and Motivational Interviewing. Aim 2: Conduct a one-arm feasibility trial with females in the juvenile justice system to assess the promise of CHOICES-TEEN. This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with master's level mental health professionals within a juvenile justice setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk of HIV, NEP, and AEP). This study will inform subsequent Stage II/III behavioral intervention studies and contribute to a missing, fundamental element in the knowledge base - further understanding of the feasibility of targeting bundled health risks in high-risk adolescents, and the potential promise of a gender-specific intervention for this population.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

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

14 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Have had vaginal intercourse with a male in the last 90 days
  • Inconsistent/ineffective contraception use
  • Inconsistent/ineffective condom use
  • Drinking at risk levels
  • Smoking
  • Available for the follow-up period

Exclusion Criteria:

  • Pregnant
  • Infertile
  • Insufficient locator information
  • Language other than English

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Choices-Teen Intervention
A three session intervention with two counseling sessions with a master's level therapist and a counseling session with a physician. The counseling with the master's level therapist utilizes a motivational interviewing approach to encourage changes in alcohol use, contraceptive use, smoking and HIV risk behaviors. This part of the intervention (a) provides norms-based-but personalized-feedback; (b) encourages participating in the smoking cessation program; (c) increases motivation to change each of the target behaviors; (d) decreases temptation to engage in risk behaviors; (e) increases confidence to avoid risk behaviors; and (f) develops a personalized, tailored change plan. The physician session provides individualized contraception and HIV risk reduction counseling.
Adfærdsmæssigt: Choices-Teen
Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Risk of alcohol-exposed pregnancy
Tidsramme: 3 months
Timeline Followback Interview
3 months
Risk of nicotine-exposed pregnancy
Tidsramme: 3 months
Timeline Followback Interview
3 months
HIV risk
Tidsramme: 3 months
Timeline Followback Interview
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Excessive alcohol consumption
Tidsramme: 3 months
AUDIT Scale
3 months
Psychological distress and symptoms
Tidsramme: 3 months
Brief Symptom Inventory -18
3 months
Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)
Tidsramme: 3 months
Decisional Balance Scale
3 months
Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)
Tidsramme: 3 months
Processes of Change Questionnaire
3 months
Temptation to engage in health risk behaviors (alcohol, smoking, HIV)
Tidsramme: 3 months
Temptation Scale
3 months
Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)
Tidsramme: 3 months
Confidence Scale
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Houston

Samarbejdspartnere

The University of Texas Health Science Center, Houston

Efterforskere

  • Ledende efterforsker: Danielle E Parrish, Ph.D., University of Houston

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. juli 2012

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

20. september 2014

Først indsendt, der opfyldte QC-kriterier

25. september 2014

Først opslået (Skøn)

30. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1R03DA034099-01 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med Choices-Teen

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Colombia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner