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

Smoking Clinical Trial

Official title:

Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth: A CBPR RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442753
• Other study ID #: 2010NTLS088
• Secondary ID: 1008S869381U54CA
• Status: Completed
• Phase: N/A
• First received: September 19, 2011
• Last updated: June 2, 2015
• Start date: September 2011
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	6 Months	No