The Impact of a Parenting Intervention on Latino Youth Health Behaviors

NCT03517111 | Terminated Results

• 2 other identifiers: ASU67972U54MD002316-11
• Study Type: interventional
• Target: 844
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification; Substance Use Disorders; Diabetes Mellitus Risk; Cardiovascular Risk Factor; Lifestyle Risk Reduction; Parenting

Outcome Measures

Primary Outcomes (20)

• 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

• 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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• Overall Family Functioning- Family Support

  Survey questions (parents) measuring: Change in family support,

  Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

• Overall Family Functioning: Family Conflict

  Sub-scale measuring family conflict.

  Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

• Overall Family Functioning- Familism

  Survey questions (parents) measuring familism subscale.

  Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (21)

• Body Weight (kg)

  Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

• Height

  Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

• Body Mass Index for Parents

  Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

• Systolic Blood Pressure

  Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

• Diastolic Blood Pressure

  Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Study Arms (3)

Nutrition/substance use prevention

EXPERIMENTAL

Parenting and nutrition curriculum targeting substance use prevention and diet improvement.

Behavioral: Nutrition/substance use prevention

Substance use prevention only

ACTIVE COMPARATOR

Parenting curriculum targeting substance use prevention only.

Behavioral: Substance use prevention only

Academic success program

SHAM COMPARATOR

Control program focused only on academic success.

Behavioral: Academic success program

Interventions

Nutrition/substance use prevention BEHAVIORAL

Parenting program focusing on diet improvement and substance use prevention

Also known as: FPNG+

Nutrition/substance use prevention

Substance use prevention only BEHAVIORAL

Parenting program focusing only on substance use prevention

Also known as: FPNG

Substance use prevention only

Academic success program BEHAVIORAL

Program focusing on academic success and college acceptance

Also known as: Realizing the American Dream (RAD)

Academic success program

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (4)

• 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.

  PMID: 31843638 BACKGROUND

• 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.

  PMID: 36617277 BACKGROUND

• 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-Grade Students. J Acad Nutr Diet. 2023 Jul;123(7):1011-1021. doi: 10.1016/j.jand.2023.02.009. Epub 2023 Feb 14.

  PMID: 36796757 RESULT

• Martinez GM, Vega-Lopez S, Ayers S, Gonzalvez A, Bruening M, Vega-Luna B, Marsiglia FF. Associations between parent-adolescent health-related conversations and mealtime media use among Hispanic families. Fam Syst Health. 2024 Jun;42(2):226-238. doi: 10.1037/fsh0000855. Epub 2023 Oct 23.

  PMID: 37870808 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Risk Reduction Behavior

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Limitations and Caveats

Enrollment numbers were smaller due to cancellations caused by social distancing restrictions caused by the global pandemic after March of 2020.

Results Point of Contact

• Title: Dr. Sonia Vega-López
• Organization: Arizona State University

sonia.vega.lopez@asu.edu

602-496-3350

Study Officials

• Flavio F Marsiglia, PhD

  Southwest Interdisciplinary Research Center, Arizona State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Nutrition and Health Promotion

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: May 7, 2018
• Study Start: September 26, 2018
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: February 26, 2024
• Results First Posted: February 26, 2024

Record last verified: 2024-02

Locations

US (1)