- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04052386
Brief Alcohol Screening for Community College Students (BASICCS)
8 augusti 2019 uppdaterad av: Christine Lee, University of Washington
The present study focuses on examining the feasibility, acceptability, and preliminary effects of an adapted alcohol intervention for high-risk college students attending community colleges.
Investigators adapted BASICS (an efficacious in-person intervention developed for high-risk drinkers attending 4-year colleges and universities) to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback.
SMS text messages with protective behavioral strategies were also provided.
The objective of the R34 was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Young adulthood (ages 18-29) is associated with increased risk for alcohol-related negative consequences; however, little is known about effective interventions for young adults attending community colleges (CCs).
Thus, it is critical to develop an intervention that meets the various needs and demanding lifestyles of CC students.
The investigators proposed to develop a user-friendly and convenient intervention that addresses relevant social norms, the impact of high-risk alcohol use on health and well-being in relevant life domains beyond student life and academic achievement, and provides ongoing exposure to behavior change strategies.
To address the notable differences between CC students and traditional 4-year students, the investigators adapted BASICS to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback (FB).
This intervention for CC students, BASICCS, will focus on relevant normative feedback and alcohol's impact on multiple roles and personal goals of the CC student.
Providing tips and protective behavioral strategies (PBS) after BASICS interventions via handouts or mailed postcards is standard practice and with preliminary evidence supporting the use of mobile phone text messaging (TM) or short message service (SMS) to reduce heavy-episodic drinking; thus, in this study SMS text messages were used to deliver ongoing protective behavioral strategies (PBS) the month after participating in the BASICCS session.
The objective of this research was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes.
CC student drinkers were recruited to participate and if eligible, they were randomized to one of two conditions (BASICCS or assessment-only control) and completed 1- and 3-month follow-ups.
Studietyp
Interventionell
Inskrivning (Faktisk)
142
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98105
- University of Washington
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 29 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- being 18-29 years old; enrolled full- or part-time at one of the three community colleges where data collection took place; consuming 4+/5+ drinks for women/men on one occasion in the past month or exceeding weekly NIAAA drinking recommendations (8+/15+ for women/men); and possessing a cell phone with text-messaging capability
Exclusion Criteria:
- not meeting inclusion criteria, not consenting to participate
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: BASICCS
Participants randomized to the BASICCS condition received a personalized feedback intervention conducted through a web-conferencing platform.
They also received up to 24 text messages with protective behavioral strategies for drinking during the following month.
|
Participants randomized to the BASICCS condition received a personalized feedback intervention conducted through a web-conferencing platform.
The personalized feedback intervention included tailored feedback on drinking quantity and frequency of alcohol, BAC, alcohol-related consequences, normative perceptions of peer drinking, alcohol outcome expectancies, family history of risk, and financial costs of alcohol.
They also received up to 24 text messages with protective behavioral strategies for drinking during the following month.
|
Inget ingripande: Control
Participants randomized to the control group did not receive any intervention.
They were an assessment-only control group.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Daily Drinking Questionnaire
Tidsram: 1-month
|
Number of standard drinks consumed each day of typical week past month
|
1-month
|
Daily Drinking Questionnaire
Tidsram: 3-month
|
Number of standard drinks consumed each day of typical week past month
|
3-month
|
Frequency of Binge Drinking
Tidsram: 1-month
|
Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)
|
1-month
|
Frequency of Binge Drinking
Tidsram: 3-month
|
Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)
|
3-month
|
Estimated Blood Alcohol Concentration (eBAC)
Tidsram: 1-month
|
estimated peak blood alcohol concentration
|
1-month
|
Estimated Blood Alcohol Concentration (eBAC)
Tidsram: 3-month
|
estimated peak blood alcohol concentration
|
3-month
|
Brief Young Adult Alcohol Consequences Questionnaire
Tidsram: 1-month
|
Number of alcohol-related consequences endorsed
|
1-month
|
Brief Young Adult Alcohol Consequences Questionnaire
Tidsram: 3-month
|
Number of alcohol-related consequences endorsed
|
3-month
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christine M Lee, PhD, University of Washington
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 januari 2017
Primärt slutförande (Faktisk)
26 juni 2017
Avslutad studie (Faktisk)
26 juni 2017
Studieregistreringsdatum
Först inskickad
7 augusti 2019
Först inskickad som uppfyllde QC-kriterierna
8 augusti 2019
Första postat (Faktisk)
9 augusti 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 augusti 2019
Senast verifierad
1 augusti 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 50262
- R34AA023047 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
We plan to share limited datasets for the purposes of data analysis and dissemination.
Tidsram för IPD-delning
Data dictionaries and limited datasets can be made available starting in September 2020.
Kriterier för IPD Sharing Access
Individual requests to access data with intended purpose should be made to Dr. Lee and will be reviewed by the investigative team.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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