- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03157700
Interactive Technology for Media Literacy Drug Prevention in Community Groups
6. februar 2021 oppdatert av: Real Prevention, LLC
This Phase II STTR will evaluate an interactive, self-paced, e-learning media literacy intervention, REAL media, to prevent youth substance use among youth in the 4-H organization.
Participating 4-H clubs will be randomly assigned to use the curriculum or continue current practices with the option for delivery at the end of the study.
4-H members (ages 13-15) will complete a pretest, immediate posttest and follow-up posttests at 3 and 9 months to assess effects.
Studieoversikt
Detaljert beskrivelse
REAL media is an interactive, self-paced, e-learning media literacy curriculum that prevents adolescent substance use among 13-15-year-old teens.
The program consists of 5 levels.
Levels 1 to 4 are 15-25 minutes; level 5 allots time for message production done offline.
Activities lead students to engage in critique and analysis of arguments present/absent from pro-ATOD and other popular product messages and to begin the process of refuting and counter-arguing these messages.
These skills are reinforced in level 5 using an active involvement strategy in which youth plan and produce anti-ATOD messages.
Users first plan their message via an online worksheet, which requires engagement with and application of media literacy concepts rather than focus exclusively on technology and/or production features.
Next, participants design their posters/videos and upload their messages to a social media site as part of a contest, where they recruit peers and family to like or comment on their message.
Studietype
Intervensjonell
Registrering (Faktiske)
642
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New Jersey
-
New Brunswick, New Jersey, Forente stater, 08901
- Rutgers, The State University of New Jersey
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
13 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 4-H members and leaders must belong to a participating club in Pennsylvania, Ohio, New Jersey, West Virginia, or Maryland
- members must be between the ages of 13-15
- club leaders must be at least 21 years of age
- written parental consent and assent from members
- written consent from club leaders (online assent)
Exclusion Criteria:
- the inability to speak or read American English
- access to and the ability to use a computer, or navigate the Internet
- for youth, lack of parental consent/youth assent/leader consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: REAL media
Participants in this group will be assigned to use the REAL media curriculum.
|
REAL media is a 5-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth substance use.
|
Ingen inngripen: Programming as usual
Participants in this group will participate in 4-H programming as usual.
They will have the opportunity to use the REAL media curriculum at the conclusion of the study.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in 15-item Intentions to Use Substances Measure
Tidsramme: Change in intentions to use within the next month from baseline to 3 months post baseline.
|
Self reported likelihood of using alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana in the following scenarios: at a party, while hanging out with friends, and while by yourself.
Response options include Definitely no, No, Yes, and Definitely Yes.
|
Change in intentions to use within the next month from baseline to 3 months post baseline.
|
Change in 15-item Intentions to Use Substances Measure
Tidsramme: Change in intentions to use within the next month from baseline to 9 months post baseline.
|
Self reported likelihood of using alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana in the following scenarios: at a party, while hanging out with friends, and while by yourself.
Response options include Definitely no, No, Yes, and Definitely Yes.
|
Change in intentions to use within the next month from baseline to 9 months post baseline.
|
Change in 5-item Lifetime Substance Use Measure
Tidsramme: Change in lifetime (e.g., ever tried) use from baseline to 3 months post baseline.
|
Self reported lifetime use of (e.g., whether you ever tried) alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana.
Response options include Yes and No.
|
Change in lifetime (e.g., ever tried) use from baseline to 3 months post baseline.
|
Change in 5-item Lifetime Substance Use Measure
Tidsramme: Change in lifetime (e.g., ever tried) use from baseline to 9 months post baseline.
|
Self reported lifetime use of (e.g., whether you ever tried) alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana.
Response options include Yes and No.
|
Change in lifetime (e.g., ever tried) use from baseline to 9 months post baseline.
|
Change in 5-item Frequency of Substance Use Measure
Tidsramme: Change in frequency of use from baseline to 3 months post baseline.
|
Self reported frequency of use of alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana.
Response options include range from 0 days to 30+ days.
|
Change in frequency of use from baseline to 3 months post baseline.
|
Change in 5-item Frequency of Substance Use Measure
Tidsramme: Change in frequency of use from baseline to 9 months post baseline.
|
Self reported frequency of use of alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana.
Response options include range from 0 days to 30+ days.
|
Change in frequency of use from baseline to 9 months post baseline.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kathryn Greene, Ph.D., Rutgers University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Greene K, Choi HJ, Glenn SD, Ray AE, Hecht ML. The Role of Engagement in Effective, Digital Prevention Interventions: the Function of Engagement in the REAL Media Substance Use Prevention Curriculum. Prev Sci. 2021 Feb;22(2):247-258. doi: 10.1007/s11121-020-01181-9. Epub 2020 Nov 3.
- Greene K, Ray AE, Choi HJ, Glenn SD, Lyons RE, Hecht ML. Short term effects of the REAL media e-learning media literacy substance prevention curriculum: An RCT of adolescents disseminated through a community organization. Drug Alcohol Depend. 2020 Sep 1;214:108170. doi: 10.1016/j.drugalcdep.2020.108170. Epub 2020 Jul 10.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. august 2018
Primær fullføring (Faktiske)
22. august 2019
Studiet fullført (Faktiske)
22. august 2019
Datoer for studieregistrering
Først innsendt
27. april 2017
Først innsendt som oppfylte QC-kriteriene
15. mai 2017
Først lagt ut (Faktiske)
17. mai 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2R42DA039595-02A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified data will be shared.
IPD-delingstidsramme
Once study is completed and publications submitted.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på REAL media curriculum
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Mental Health (NIMH)Fullført
-
Göteborg UniversityIOGT-NTO's Junior AssociationUkjentMotstandsdyktighet
-
University of MinnesotaHar ikke rekruttert ennå
-
University of Southern CaliforniaFullførtSukkersykeForente stater
-
The Center for Mind-Body MedicineSilicon Valley Community FoundationFullført
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; University of Magdeburg; University of WaterlooRekruttering
-
University Hospital of FerraraFullførtMinimalt bevisst tilstand | TBIItalia
-
BaycrestFullførtSubjektiv kognitiv nedgangCanada
-
University of WashingtonNational Institute on Drug Abuse (NIDA)RekrutteringOvervekt, ungdom | Stillesittende atferd | Narkotikamisbruk | Sunn ernæringForente stater