Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth

NCT ID: NCT01442753

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Use Disorder Alcohol Use Disorder Drug Use Disorder Smoking Alcohol Drinking Drug Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Family-Skills Training

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Family-Skills Training

Intervention Type BEHAVIORAL

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.

Interventions

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Family-Skills Training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* Past participant Padres Informados parenting program

Exclusion Criteria

* Parent Exclusion
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele Allen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28207680 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23253201 (View on PubMed)

Other Identifiers

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1008S86938

Identifier Type: OTHER

Identifier Source: secondary_id

1U54CA153603-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010NTLS088

Identifier Type: -

Identifier Source: org_study_id

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