The Impact of a Parenting Intervention on Latino Youth Health Behaviors (FPNG+)

• ClinicalTrials.gov Identifier: NCT03517111
• Recruitment Status: Recruiting
• First Posted: May 7, 2018
• Last Update Posted: June 8, 2021
• Sponsor: Arizona State University
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Sonia Vega-Lopez, Arizona State University

Study Description

Brief Summary:

The purpose of this study is to test if a parenting program can be used to prevent substance use among Latino youth and at the same time promote healthy eating. Pairs of 7th grade students and one of their parents will be enrolled in the study and randomly assigned to three groups: an existing parenting intervention focusing on substance use prevention (FPNG), the enhanced parenting intervention that also has nutrition content (FPNG+), and a comparison program focused on academic success. Only parents will attend intervention sessions. Data will be collected from the parent and their 7th grade student to see how these programs impacted substance use, nutrition, and parenting. The investigators hypothesize that families receiving the FPNG+ will have improved nutrition habits than the other conditions. Students in both FPNG and FPNG+ will have lower substance use rates as compared to the academic success program. In addition, the effects of parenting strategies and sociocultural factors on the FPNG and FPNG+ results will be studied.

Condition or disease	Intervention/treatment	Phase
Diet Modification; Substance Use Disorders; Diabetes Mellitus Risk; Cardiovascular Risk Factor; Lifestyle Risk Reduction; Parenting	Behavioral: Nutrition/substance use prevention; Behavioral: Substance use prevention only; Behavioral: Academic success program	Not Applicable

Detailed Description:

Latino youth are a population at risk for chronic diseases because of their growing overweight and obesity rates, lack of adherence to nutrition and physical activity recommendations, and greater rates of tobacco, alcohol and other drugs use than youth of other ethnic groups. Parents are an important agent of change for youth due to their ability to create a home environment that promotes healthful behaviors (including substance use prevention and healthy nutrition), and parents' role as providers of resources to the family (including food). Parenting interventions are efficacious in preventing substance use among Latino youth, but few studies have used a family approach to promote healthy nutrition. Thus, the overall objective of the proposed project is to extend the scope of Families Preparing the New Generation (FPNG), an existing parenting program proven to help reduce substance use among Latino youth, to also promote healthy nutrition. The eco-developmental perspective will provide the theoretical foundation for the project for investigating risk and resiliency in Latino youth's drug use and nutrition behaviors. The main aims of the study are to (1) test the effects of a nutrition-enhanced parenting program (FPNG+) on substance use and nutrition among Latino youth, (2) explore how enhancing parenting skills impact the effects of the enhanced intervention, and (3) understand how social and cultural factors impact how the enhanced program works. The research team will first seek input from community members to create a nutrition-enhanced program that is acceptable to Latino parents of middle school students. The investigators will then collaborate with the American Dream Academy (ADA), an organization delivering an academic success program to families within middle schools throughout the Phoenix Area, to recruit 1,494 families who have a student in 7th grade to participate in the study. Parents from different schools will be offered one of three 10-week programs (assigned to each individual school): FPNG+ (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and the ADA comparison program (focusing on academic success). Data will be collected from the 7th grade student and his/her participating parent before the start of the program, immediately after it ends, and 16 weeks later, to compare how the programs affect nutrition, substance use, and parenting. In a subgroup of 126 families (42 from each program), investigators will explore how the FPNG+ program affects diabetes and cardiovascular risk factors and whether the program induces changes in the types of foods available at participants' homes. For this, investigators will collect capillary blood samples from participants to measure glycosylated hemoglobin (a marker of diabetes risk) and cholesterol (a marker of cardiovascular risk), and blood pressure, as well as a list of foods that participants have at home. The long-term goal is to design and disseminate programs that contribute to helping parents assist their adolescent children develop and maintain long-lasting positive lifestyle behaviors in order to prevent substance use and chronic diseases.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2988 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomization to treatment conditions (FPNG+, FPNG, or comparison [RAD]) will occur at the school level. From the 18 participating schools, 6 each will be randomized into one of the three conditions.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Multi-level Effects of a Parenting Intervention for Enhancing Latino Youth Health Behaviors
• Actual Study Start Date: September 26, 2018
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Nutrition/substance use prevention; Parenting and nutrition curriculum targeting substance use prevention and diet improvement.	Behavioral: Nutrition/substance use prevention; Parenting program focusing on diet improvement and substance use prevention; Other Name: FPNG+
Active Comparator: Substance use prevention only; Parenting curriculum targeting substance use prevention only.	Behavioral: Substance use prevention only; Parenting program focusing only on substance use prevention; Other Name: FPNG
Sham Comparator: Academic success program; Control program focused only on academic success.	Behavioral: Academic success program; Program focusing on academic success and college acceptance; Other Name: Realizing the American Dream (RAD)

Outcome Measures

Primary Outcome Measures :

1. Recent use of substances [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Survey questions: Changes in amount and frequency of alcohol, cigarettes, marijuana, and inhalants in the past 30 days. Scale ranges from 1 (no use of substance) to 7 (used 40 or more times). Higher score indicates more use.
2. Drug resistance strategies [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Survey questions: Change in youths' responses to substance use offers in the past 30 days and likely responses to hypothetical substance use offers. Scale ranges from 1 (never responded in this way) to 6 (responded this way more than 10 times).
3. Nutrition outcomes [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   NCI Dietary Screener: Change in intake of fruit, vegetables, and sugar-laden foods
4. Overall family functioning [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Survey questions (parents) measuring: Change in family support, family conflict, parental monitoring, extent of involvement, and familism.
5. Parents' social support [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Social Support Questionnaire score. Scale from 1 (very dissatisfied with support) to 6 (very satisfied with support). Higher scores mean more social support.
6. Acculturation [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Acculturation Rating Scale for Mexican Americans-II (ARSMA-II) asks participants to indicate on a five point likert scale (Not at all (1) and Extremely often or almost always (5)) the extent to which they engage in 17 Mexican oriented behaviors. The Anglo Orientation Subscale (AOS) consists of 13 items, which asks participants to indicate on a five point likert scale (Not at all (1) and Extremely often or almost always (5)) the extent to which they engage in Anglo oriented behaviors. Means for each subscale are calculated, higher score means higher Mexican orientation and higher Anglo orientation.
7. Food Insecurity [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Assesses financially-based food insecurity and hunger in households.
8. Self-efficacy for Parenting Index [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   A measure of parental beliefs that he/she is capable of performing parental roles/responsibilities
9. Parent self-agency [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Gauges the parent's sense of parenting competence and ability to positively influence the child's development
10. Child Feeding Questionnaire [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
    assesses parental attitudes, beliefs and practices about feeding
11. Multidimensional Acculturative Stress Inventory [ Time Frame: Week 0, Week 10-12, Week 24-26 ]

    Measures how often a person experienced certain acculturation situations and how stressful they were.

    Scale ranges from 0 (No, did not happen to me) to 5 (Extremely stressful). Mean score is created, where higher values indicate more acculturative stress.

Secondary Outcome Measures :

1. Body weight [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Measured body weight for parents and youth.
2. Height [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Measured height for parents and youth.
3. Body mass index [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Calculated BMI for parents and youth estimated by dividing weight by height squared
4. Systolic blood pressure [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Measured systolic blood pressure using an automated blood pressure monitor
5. Diastolic blood pressure [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Measured diastolic blood pressure using an automated blood pressure monitor
6. Total cholesterol [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Total cholesterol measured via finger prick blood sample
7. Glycosylated hemoglobin (HbA1c) [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   HbA1c measured via finger prick blood sample
8. Diet of adolescents [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   2004 Block Food Frequency Questionnaire
9. Diet of the parents [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
   Southwestern Food Frequency Questionnaire
10. Home food environment [ Time Frame: Week 0, Week 10-12, Week 24-26 ]
    Modified version of the validated Home Food Inventory with cultural adaptations including foods commonly consumed by Latinos.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:

• Youth: ages 12-14
• Youth: Enrolled in 6th,7th, or 8th grade at the time of recruitment from the American Dream Academy (ADA) programs
• Adults: Age 18 or older
• Adults: Parent/caregiver/guardian of an eligible youth

Exclusion Criteria: None

Contacts and Locations

Contacts

Contact: Sonia Vega-López, PhD; (602) 827-2268; Sonia.Vega.Lopez@asu.edu

Locations

United States, Arizona

Arizona State University; Recruiting

Phoenix, Arizona, United States, 85004

Sponsors and Collaborators

Arizona State University

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Flavio F Marsiglia, PhD; Southwest Interdisciplinary Research Center, Arizona State University

More Information

Publications:

Vega-López S, Marsiglia FF, Ayers S, Williams LR, Bruening M, Gonzalvez A, Vega-Luna B, Perilla A, Harthun M, Shaibi GQ, Delgado F, Rosario C, Hartmann L. Methods and rationale to assess the efficacy of a parenting intervention targeting diet improvement and substance use prevention among Latinx adolescents. Contemp Clin Trials. 2020 Feb;89:105914. doi: 10.1016/j.cct.2019.105914. Epub 2019 Dec 13.

• Responsible Party: Sonia Vega-Lopez, Associate Professor, School of Nutrition and Health Promotion, Arizona State University
• ClinicalTrials.gov Identifier: NCT03517111
• Other Study ID Numbers: ASU6797; 2U54MD002316-11 ( U.S. NIH Grant/Contract )
• First Posted: May 7, 2018
• Last Update Posted: June 8, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders