- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01081119
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth (CHOICE)
9. juli 2014 opdateret af: RAND
We are currently working in 16 middle schools across Los Angeles, Santa Monica and Torrance to test out a voluntary after school program called Project CHOICE, which focuses on helping students decrease their alcohol and drug use.
We are conducting surveys in all schools over three years and providing the intervention in 8 schools in the 2008-2009 school year and in the other 8 schools in the 2011-2012 school year.
This is a program we have provided before in middle schools and we found that it was effective in curbing alcohol and drug use among students who voluntarily attended and among all students at the intervention school.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The middle school years are peak years for initiation of alcohol and marijuana (Johnston et al., 2007).
Unfortunately, most youth who engage in substance use and experience problems are unlikely to voluntarily make use of formal prevention services (D'Amico, 2005; Johnson et al., 2001; Wu et al., 2003).
A small body of recent research suggests that youth may benefit from less formal programs that are brief, voluntary, and easily accessible (Brown, 2001; D'Amico et al., 2005).
However, very few intervention programs of this type have been developed (Little and Harris, 2003).
Thus, while this approach shows promise, the impact of intervention programs that younger teens may choose to attend has not been extensively examined.
One such intervention, Project CHOICE, was developed and tested by the PI using NIAAA funding for developmental work (R21AA13284).
Project CHOICE is the only voluntary intervention that has been tested for middle school youth and our small quasi-experimental study has demonstrated its efficacy in one school setting (D'Amico and Edelen, in press; D'Amico et al., 2005).
The Project CHOICE intervention addresses several critical gaps in the field, including beginning to understand voluntary service utilization among this age group and assessing how this type of program may impact school-wide use of alcohol and other drugs (AOD).
The main objective of the proposed 5-year longitudinal study is to build on our initial work by conducting a more rigorous test of Project CHOICE.
The study will include 16 middle schools, located in the ethnically diverse Southern California cities of Los Angeles, Santa Monica, and Torrance.
These schools will be randomly assigned as intervention (n= 8) or control (n = 8).
We will first examine individual-level effects by testing whether Project CHOICE affects AOD-related outcomes among students who participate in the intervention.
We will then examine school-level effects by testing whether AOD rates among all students in the intervention schools are affected, regardless of participation.
We assume that these school-level effects will be due to changes in the school environment (e.g., Project CHOICE advertising, discussion of Project CHOICE among students, changes in social norms).
In anticipation of this school-level impact, a secondary objective of this study is to gain a better understanding of who participates in Project CHOICE, as well as how these participants and changes in the school environment may influence the attitudes and behaviors of those who do not participate.
This research incorporates a novel methodology for AOD involvement, as it emphasizes personal self-change efforts and natural recovery and is appealing to both using and non-using youth.
The work proposed in this application represents the important next step in this line of research: to more critically evaluate Project CHOICE and its potential impact on both school-wide and individual outcomes with a larger population of youth.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6455
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater
- 16 middle schools in Torrance, Santa Monica, and Los Angeles
-
-
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
11 år til 15 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria: Adolescents between the ages of 11 and 15 who are currently attending one of 16 selected middle schools across Los Angeles, Torrance, and Santa Monica -
Exclusion Criteria: None
-
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Project CHOICE
Middle school receives Project CHOICE
|
Voluntary after school program offered 1 day per week for 30 minutes
|
Ingen indgriben: No Project CHOICE
Middle school does not receive Project CHOICE
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Alcohol, cigarette, and marijuana use
Tidsramme: 3 years
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Substance use-related cognitions
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Elizabeth J. D'Amico, PhD, RAND
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. september 2008
Primær færdiggørelse (Faktiske)
1. juni 2012
Studieafslutning (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først indsendt
3. marts 2010
Først indsendt, der opfyldte QC-kriterier
3. marts 2010
Først opslået (Skøn)
5. marts 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01AA016577 (U.S. NIH-bevilling/kontrakt)
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 .
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