NCT01442753

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

3.3 years

First QC Date

September 19, 2011

Last Update Submit

June 2, 2015

Conditions

Keywords

Spanish speaking

Outcome Measures

Primary Outcomes (1)

  • Comparison of susceptibility rate differences between the control and intervention groups

    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'.

    6 Months Post Intervention

Secondary Outcomes (1)

  • Effect of a family-based intervention

    6 Months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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.

Behavioral: Family-Skills Training

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Family-Skills Training

Interventions

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 GroupIntervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Either mother or father born in Latin American country
  • Speaks Spanish
  • Parent willing to give consent for self \& youth
  • Age 10-14 years
  • Speak English or Spanish
  • Youth willing to give assent

You may not qualify if:

  • Past participant Padres Informados parenting program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Tobacco Use DisorderAlcoholismSubstance-Related DisordersSmokingAlcohol Drinking

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related DisordersBehaviorDrinking Behavior

Study Officials

  • Michele Allen, M.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 29, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations