Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
2. juni 2015 oppdatert av: University of Minnesota
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth: A CBPR RCT
The goal of this project is to evaluate the effectiveness of a family-based tobacco use prevention intervention directed at immigrant Latino parents of middle school aged youth as delivered in partnership with seven community organizations.
The primary outcomes of the study are youth susceptibility to tobacco use, and changes in parenting practices among the parents of the youth.
The planning, initiation, and delivery of the intervention will occur in collaboration with community organizations that have identified this project as important to the families they serve.
Though the collaboratively designed training curriculum has been successfully tested and a study design for the current project established, a substantive development period for this project will allow the research team and collaborating organizations to consider key aspects of design and delivery.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study design is a randomized (at the level of the family) controlled trial (RCT), with a delayed treatment condition for the control group.
Participants will be enrolled from community agencies known and trusted within the Latino community including two clinics, a school, three social service agencies and a University of Minnesota Extension site that are likely end-users of the intervention programming.
Studietype
Intervensjonell
Registrering (Faktiske)
800
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55414
- University of Minnesota
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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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Parent Inclusion
- Either mother or father born in Latin American country
- Speaks Spanish
- Parent willing to give consent for self & youth
Youth Inclusion
- Age 10-14 years
- Speak English or Spanish
- Youth willing to give assent
Exclusion Criteria:
Parent Exclusion
- Not meeting inclusion criteria
- Past participant Padres Informados parenting program
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: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Intervention Group
Families will be randomized to either receive the intervention (family-skills training) immediately.
The intervention will be delivered over eight weeks.
Sessions will be divided between self-reflection, didactics, and skill-building exercises all aimed at developing strong parenting practices and facilitating relationship building between parents and youth.
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Sessions will be divided between self-reflection, didactics, and skill-building exercises all aimed at developing strong parenting practices and facilitating relationship building between parents and youth.
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Aktiv komparator: Control Group
Control group will receive the intervention (family-skills training) in approximately ten months.
The intervention will be delivered over eight weeks.
Sessions will be divided between self-reflection, didactics, and skill-building exercises all aimed at developing strong parenting practices and facilitating relationship building between parents and youth.
|
Sessions will be divided between self-reflection, didactics, and skill-building exercises all aimed at developing strong parenting practices and facilitating relationship building between parents and youth.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of susceptibility rate differences between the control and intervention groups
Tidsramme: 6 Months Post Intervention
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Youth tobacco use intentions, Questions are 1) "Do you think you will try a cigarette soon?' (not asked of puffers), 2) "Do you think you will be smoking cigarettes one year from now?", and 3) "If one of your best friends were to offer you a cigarette, would you smoke it?"
A never-smoker will be considered non-susceptible if answer to the first question is 'No' and answers to both questions 2 and 3 are 'Definitely not'; a puffer will be considered non-susceptible if answers to questions 2 and 3 are 'Definitely not'.
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6 Months Post Intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Effect of a family-based intervention
Tidsramme: 6 Months
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Parenting behaviors - Monitoring knowledge: child disclosure, parental solicitation and control.
Personal involvement: measures parent behavior indicative of their efforts to be aware of adolescents' activities and experiences.
Consistent discipline: scale based on work conducted at the ASU Prevention Research Center.
Self-efficacy - parent perceives him/herself capable of performing behaviors instrumental to good parenting practice/good developmental outcomes for their children.
Social Support: The MSPSS101 measures perceived support from 3 domains: family, friends, and significant other.
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6 Months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michele Allen, M.D., Masonic Cancer Center, University of Minnesota
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
- Allen ML, Hurtado GA, Garcia-Huidobro D, Davey C, Forster J, Reynoso U, Alvarez de Davila S, Linares R, Gonzales N, Veronica Svetaz M. Cultural Contributors to Smoking Susceptibility Outcomes Among Latino Youth: The Padres Informados/Jovenes Preparados Participatory Trial. Fam Community Health. 2017 Apr/Jun;40(2):170-179. doi: 10.1097/FCH.0000000000000147.
- Allen ML, Garcia-Huidobro D, Hurtado GA, Allen R, Davey CS, Forster JL, Hurtado M, Lopez-Petrovich K, Marczak M, Reynoso U, Trebs L, Svetaz MV. Immigrant family skills-building to prevent tobacco use in Latino youth: study protocol for a community-based participatory randomized controlled trial. Trials. 2012 Dec 19;13:242. doi: 10.1186/1745-6215-13-242.
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
1. september 2011
Primær fullføring (Faktiske)
1. januar 2015
Studiet fullført (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først innsendt
19. september 2011
Først innsendt som oppfylte QC-kriteriene
27. september 2011
Først lagt ut (Anslag)
29. september 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
4. juni 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juni 2015
Sist bekreftet
1. juni 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2010NTLS088
- 1008S86938 (Annen identifikator: IRB, University of Minnesota)
- 1U54CA153603-01 (U.S. NIH-stipend/kontrakt)
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. .