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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tobacco Use Disorder, Alcohol Use Disorder, Drug Use Disorder, Smoking, Alcohol Drinking, Drug Abuse

Intervention / Treatment
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* Behavioral: Family-Skills Training


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>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<br>* 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.<br>|
| Active Comparator: Control Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spanish speaking