The Impact of a Parenting Intervention on Latino Youth Health Behaviors

Substance Use Disorders Clinical Trial

— FPNG+  

Official title:

Multi-level Effects of a Parenting Intervention for Enhancing Latino Youth Health Behaviors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03517111
• Other study ID #: ASU6797
• Secondary ID: 2U54MD002316-11
• Status: Terminated
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2024
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 844
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Diabetes Mellitus Risk
• Diet Modification
• Lifestyle Risk Reduction
• Parenting
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Nutrition/substance use prevention
Parenting program focusing on diet improvement and substance use prevention
• Substance use prevention only
Parenting program focusing only on substance use prevention
• Academic success program
Program focusing on academic success and college acceptance

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Masek E, Gonzalvez A, Rankin L, Vega de Luna B, Valdez HJ, Hartmann L, Lorenzo E, Bruening M, Marsiglia FF, Harthun M, Vega-Lopez S. Qualitative Research on the Perceptions of Factors Influencing Diet and Eating Behaviors Among Primarily Latinx Seventh-Gr — View Citation

Mercado M, Vega-Lopez S, Gonzalvez A, Vega-Luna B, Hoyt S, Martinez G, Ayers S, Marsiglia FF. Adaptation process of a culturally congruent parenting intervention for parents of Hispanic adolescents to an online synchronous format. Transl Behav Med. 2023 Apr 3;13(3):160-167. doi: 10.1093/tbm/ibac097. — View Citation

Vega-Lopez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adolescent Recent Alcohol Intake Frequency	Question: In the past 30 days, how many times have you...drunk more than a sip of beer, wine or liquor? Scale: 0 = 0; 1 = 1-2 times; 2 = 3-5 times; 3 = 6-9 times; 4 = 10-19 times; 5 = 20-39 times; 6 = 40 or more times	(T1) Week 0, (T2) Week 10-12, (T3) Week 24-26
Primary	Adolescent Recent Alcohol Intake Amount	Question: How many drinks of alcohol (more than a sip of beer, wine, or liquor) have you had in the past 30 days? Scale: 0 = None; 1 = One drink; 2 = 2-3 drinks; 3 = 4-7 drinks; 4=8-15 drinks; 5=16-30 drinks; 6= More than 30 drinks	(T1) Week 0, (T2) Week 10-12, (T3) Week 24-26
Primary	Drug Resistance Strategies	Survey questions: Change in youths' responses to substance use offers in the past 30 days. Scale ranges from 0 (never responded in this way) to 5 (responded this way more than 10 times).; Change in youths' intention to use substances measured as likely responses to hypothetical substance use offers. Scale ranges from 1 (Definitely no) to 4 (Definitely yes).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Self-efficacy for Parenting Index	A measure of parental beliefs that he/she is capable of performing parental roles/responsibilities	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Parents' Social Support	Social Support Questionnaire score, scale from 1 to 7. Higher scores mean more social support.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Parent Self-agency	Gauges the parent's sense of parenting competence and ability to positively influence the child's development. Scale from 1-5, with higher score=more agency.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Overall Family Functioning- Parental Monitoring Subscale	Survey questions (parents) measuring: Change in parental monitoring. Average of a 9-item scale, where each question is measured on a 5-point scale (1=Never, 5=Always).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Overall Family Functioning- Parental Involvement	From Gorman-Smith, Tolan, Zelli & Huesmann (1996) - These items measure the extent to which the parent is involved in the child's life. Respondents are asked to indicate how often they engage in certain interactions with their children (Q1-2) and how often the child is involved in family activities (Q3-10). For the first two questions, (when was the most recent time parent and youth talked about certain things), the scale goes from 1 (I don't know) to 5 (yesterday or today). For questions 3-10, activities include: how often the youth helps with family fun activities, how often parent and youth have a friendly talk, whether the youth helps with chores, or errands, etc. The scale goes from 1 (hardly ever) to 5 (often). Point values are summed (MIN=10, MAX=50), and then divided by the total number of items. Higher scores indicate greater levels of parental monitoring and involvement.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Overall Family Functioning- Family Support	Survey questions (parents) measuring: Change in family support,	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Overall Family Functioning: Family Conflict	Sub-scale measuring family conflict.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Overall Family Functioning- Familism	Survey questions (parents) measuring familism subscale.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Acculturation- Mexican Orientation Scale	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 certain cultural behaviors. The Mexican Orientation Subscale (MOS) consists of 17 Mexican oriented behaviors, which asks participants to indicate on the five point likert scale (Not at all (1) and Extremely often or almost always (5)) the extent to which they engage in Mexican-oriented behaviors. Means for each subscale are calculated, higher score indicates higher Mexican orientation.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Acculturation- Anglo Orientation Subscale	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 certain cultural behaviors. The Anglo Orientation Subscale (AOS) consists of 13 items, which asks participants to indicate on the 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 indicates higher Anglo orientation.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Multidimensional Acculturative Stress Inventory	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.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Nutrition Outcomes- Fruit Intake	NCI Dietary Screener: Change in intake of fruit- estimated cups per day	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Nutrition Outcomes-vegetables	NCI Dietary Screener: Change in intake of vegetables- estimated cups per day	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Nutrition Outcomes-sugar-laden Foods	NCI Dietary Screener: Change in intake of added sugars- estimated teaspoons per day	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Child Feeding Questionnaire- Weight-related Outcomes	3 item subscale measuring how often parents discussed certain weight-related topics with their adolescent (1=Never or rarely; 5=Almost every day).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Child Feeding Questionnaire- Health-related Outcomes	3 item subscale measuring how often parents discussed certain health-related topics with their adolescent (1=Never or rarely; 5=Almost every day).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Primary	Food Insecurity	This five-item scale is based on an 18-item validated food insecurity scale (Blumberg et al., 1999), for use when resources do not allow the use of the full scale. It assesses financially-based food insecurity and hunger in households with and without children. Questions 1 and 2 assess if food bought didn't last, and if they couldn't afford balanced meals; scale from 1=often true to 3=never true. The rest of the questions ask about actions the parent had to take due to lack of food; it's measured on a three-point scale where 1=No, 2=Yes, and 3=I don't know.; The total number of affirmative responses is tallied: Questions 1 & 2, "Often" and "Sometimes" are considered affirmative responses; Question 3, "Yes, some months but not every month" and "Yes, almost every month" are considered affirmative responses; Questions 4 and 5, "Yes" is considered affirmative response. Minimum value is 0, maximum value is five. A greater score indicates higher level of food insecurity.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Body Weight (kg)	Measured body weight in kilograms (kg) for parents and youth. Calculated by taking the average of 3 consecutive weight readings.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Height	Measured height for parents and youth in centimeters. Calculated by taking the average of three consecutive readings.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Body Mass Index for Parents	Calculated BMI (body max index) for parents estimated by dividing weight (in kg) by height (in m) squared, with the unit of measure being kg/m^2. Typically, 18.5-24.9 is considered healthy weight; 25.0-29.9 is overweight; and equal or greater than 30.0 indicates obesity.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Systolic Blood Pressure	Measured systolic blood pressure using an automated blood pressure monitor. Calculated by taking the average of three consecutive measures. Normal range is less than 120mm Hg (units of millimeters of mercury).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Diastolic Blood Pressure	Measured diastolic blood pressure using an automated blood pressure monitor. Calculated by taking the average of three consecutive measures. Normal range is less than 80 mmHg (units of millimeters of mercury).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Total Cholesterol	Total cholesterol measured via finger prick blood sample. Total cholesterol is measured in milligrams of cholesterol per deciliter of blood. Scores 200 mg/dL and over are considered high.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Glycosylated Hemoglobin (HbA1c)	HbA1c measured via finger prick blood sample using a point of care device; this measures the average blood sugar levels over the past 3 months. For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet- Total Energy (kcal)	Total energy from food (kcal) based off 24 hour food recalls	Week 0 (t1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet- Total Dietary Fiber (g)	Total dietary fiber in grams, based on 24 hour food recalls.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Home Food Environment - Vegetable Availability	Modified version of the validated Home Food Inventory with cultural adaptations including foods commonly consumed by Latinos used to inventory number of different vegetable items present in the home. Reporting on variable: # of vegetable items present in the home.	Week 0 (Time 1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	BMI % for Youth	BMI percentile, expressing a child's BMI relative to US children who participated in national surveys from 1963-65 to 1988-94. Typically, weight status categories are as follows: healthy weight is considered 5th percentile to less than the 85th percentile; 85th to less than the 95th percentile indicates overweight, and above the 95th percentile indicates obesity.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - % Calories From Fat	Percentage of daily calories that come from fat	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - % Calories From Carbs	Percentage of daily calories that come from carbohydrate sources	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - % Calories From Protein	Percentage of daily calories that come from protein sources	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - % Calories From Saturated Fats	Percentage of daily calories that come from saturated fat sources	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - % Calories From Monounsaturated Fats	Percentage of daily calories that come from monounsaturated fat sources (MUFA).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - % Calories From Polyunsaturated Fats	Percentage of daily calories that come from polyunsaturated fat sources (PUFA).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - Total Sugars (g)	Total sugars in daily diet, measured in grams.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - Added Sugars (g)	Total added sugars in daily diet, measured in grams. This does not include foods like fruit, with naturally occurring sugars.	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - Whole Grains (oz)	Total whole grains in daily diet, measured in ounce equivalents (oz).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)
Secondary	Parent and Adolescent Diet - Refined Grains (oz)	Total refined grains in daily diet, measured in ounce equivalents (oz).	Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)