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

Primary Purpose

Tobacco Use Disorder, Alcohol Use Disorder, Drug Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Skills Training
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Disorder focused on measuring Spanish speaking

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

Effect of a family-based intervention
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.

Full Information

First Posted
September 19, 2011
Last Updated
June 2, 2015
Sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01442753
Brief Title
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
Official Title
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth: A CBPR RCT
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Alcohol Use Disorder, Drug Use Disorder, Smoking, Alcohol Drinking, Drug Abuse
Keywords
Spanish speaking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family-Skills Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of susceptibility rate differences between the control and intervention groups
Description
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'.
Time Frame
6 Months Post Intervention
Secondary Outcome Measure Information:
Title
Effect of a family-based intervention
Description
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Allen, M.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28207680
Citation
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.
Results Reference
derived
PubMed Identifier
23253201
Citation
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.
Results Reference
derived

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

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