Clinical trial NCT01442753: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Alcohol Use Disorder
Drug Use Disorder
Smoking
Alcohol Drinking
Drug Abuse
Keywords: Spanish speaking
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-09-29
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Comparison of susceptibility rate differences between the control and intervention groups
timeFrame: 6 Months Post Intervention
Secondary outcomes:
measure: Effect of a family-based intervention
timeFrame: 6 Months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Michele Allen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.