Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
2. juni 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
800
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55414
- University of Minnesota
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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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
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 |
|---|---|
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michele Allen, M.D., Masonic Cancer Center, University of Minnesota
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
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 2011
Primær færdiggørelse (Faktiske)
1. januar 2015
Studieafslutning (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først indsendt
19. september 2011
Først indsendt, der opfyldte QC-kriterier
27. september 2011
Først opslået (Skøn)
29. september 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2010NTLS088
- 1008S86938 (Anden identifikator: IRB, University of Minnesota)
- 1U54CA153603-01 (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 .