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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01442753
First received: September 19, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Tobacco Use Disorder
Alcohol Use Disorder
Drug Use Disorder
Smoking
Alcohol Drinking
Drug Abuse
Behavioral: Family-Skills Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth: A CBPR RCT

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Comparison of susceptibility rate differences between the control and intervention groups [ Time Frame: 6 Months Post Intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 800
Study Start Date: September 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442753

Contacts
Contact: Michele Allen, M.D. 612-625-4760 miallen@umn.edu
Contact: Ghaffar A. Hurtado 612-624-2709 hurt0033@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Michele L Allen, MD    612-625-4760    miallen@umn.edu   
Principal Investigator: Michele L Allen, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Michele Allen, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01442753     History of Changes
Other Study ID Numbers: 2010NTLS088, 1008S86938, 1U54CA153603-01
Study First Received: September 19, 2011
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Spanish speaking

Additional relevant MeSH terms:
Alcohol Drinking
Substance-Related Disorders
Tobacco Use Disorder
Drinking Behavior
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014