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NCT03517111: FPNG+

The Impact of a Parenting Intervention on Latino Youth Health Behaviors

Terminated NA Results posted Last updated 26 February 2024
What this trial tests

NA trial testing Nutrition/substance use prevention in Diet Modification in 844 participants. Terminated before completion.

Timeline
26 September 2018
Primary endpoint
31 March 2022
31 March 2022

Quick facts

Lead sponsorArizona State University
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment844
Start date26 September 2018
Primary completion31 March 2022
Estimated completion31 March 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Arizona State University

Who can join

12 and older, any sex, with Diet Modification or Substance Use Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adolescent Recent Alcohol Intake Frequency Primary · (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26

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)
GroupValue95% CI
Nutrition/Substance Use Prevention0.05± 0.25
Substance Use Prevention Only0.14± 0.66
Academic Success Program0.1± 0.41
T2 (Weeks 10-12)
GroupValue95% CI
Nutrition/Substance Use Prevention0.06± 0.28
Substance Use Prevention Only0.18± 0.83
Academic Success Program0.05± 0.23
T3 (Weeks 24-26)
GroupValue95% CI
Nutrition/Substance Use Prevention0.03± 0.18
Substance Use Prevention Only0.12± 0.83
Academic Success Program0.09± 0.41
Adolescent Recent Alcohol Intake Amount Primary · (T1) Week 0, (T2) Week 10-12, (T3) Week 24-26

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)
GroupValue95% CI
Nutrition/Substance Use Prevention0.01± 0.08
Substance Use Prevention Only0.11± 0.56
Academic Success Program0.12± 0.54
T2 (Weeks 10-12)
GroupValue95% CI
Nutrition/Substance Use Prevention0.00± 0.00
Substance Use Prevention Only0.14± 0.82
Academic Success Program0.05± 0.23
T3 (Weeks 24-26)
GroupValue95% CI
Nutrition/Substance Use Prevention0.03± 0.18
Substance Use Prevention Only0.11± 0.82
Academic Success Program0.01± 0.12
Drug Resistance Strategies Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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).

Baseline (T1) drug resistance strategies
GroupValue95% CI
Nutrition/Substance Use Prevention1.1157± 1.43786
Substance Use Prevention Only1.3364± 1.78485
Academic Success Program1.2695± 1.5919
All Conditions1.2177± 1.57104
T2 drug resistance strategies
GroupValue95% CI
Nutrition/Substance Use Prevention.7321± 1.11529
Substance Use Prevention Only.9273± 1.50745
Academic Success Program1.1853± 1.79173
All Conditions.9294± 1.47036
T3 drug resistance strategies
GroupValue95% CI
Nutrition/Substance Use Prevention.7445± 1.34628
Substance Use Prevention Only.9314± 1.68751
Academic Success Program.7874± 1.49095
All Conditions.8037± 1.47654
Baseline (T1) intentions to use substances (higher score=higher intention)
GroupValue95% CI
Nutrition/Substance Use Prevention1.0947± .25029
Substance Use Prevention Only1.2045± .44381
Academic Success Program1.1526± .96982
All Conditions1.1394± .34513
T2 intentions to use substances (higher score=higher intention)
GroupValue95% CI
Nutrition/Substance Use Prevention1.1046± .30865
Substance Use Prevention Only1.1545± .35516
Academic Success Program1.1809± .41553
All Conditions1.1419± .35825
T3 intentions to use substances (higher score=higher intention)
GroupValue95% CI
Nutrition/Substance Use Prevention1.0914± .25746
Substance Use Prevention Only1.1179± .30463
Academic Success Program1.1739± .50239
All Conditions1.1244± .36403
Parents' Social Support Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

Social Support Questionnaire score, scale from 1 to 7. Higher scores mean more social support.

Baseline (T1) social support
GroupValue95% CI
Nutrition/Substance Use Prevention5.7689± 1.20103
Substance Use Prevention Only5.4489± 1.51703
Academic Success Program5.5684± 1.38217
All Groups5.6292± 1.33993
T2 social support
GroupValue95% CI
Nutrition/Substance Use Prevention5.8381± 1.24913
Substance Use Prevention Only5.6591± 1.38356
Academic Success Program5.5846± 1.44316
All Groups5.71± 1.34744
T3 social support
GroupValue95% CI
Nutrition/Substance Use Prevention5.7186± 1.1698
Substance Use Prevention Only5.4725± 1.32787
Academic Success Program5.5744± 1.28869
All Groups5.6094± 12.444
Parent Self-agency Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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.

Baseline (T1) parental self agency
GroupValue95% CI
Nutrition/Substance Use Prevention4.221± .51603
Substance Use Prevention Only4.1176± .55733
Academic Success Program4.2744± .51299
All Conditions4.2146± .52579
T2 parental self agency
GroupValue95% CI
Nutrition/Substance Use Prevention4.3879± .51354
Substance Use Prevention Only4.3868± .46939
Academic Success Program4.314± .52859
All Conditions4.3625± .50744
T3 parental self agency
GroupValue95% CI
Nutrition/Substance Use Prevention4.3946± .42518
Substance Use Prevention Only4.4078± .46167
Academic Success Program4.3822± .49498
All Conditions4.3938± .45615
Overall Family Functioning- Parental Monitoring Subscale Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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).

Baseline (T1) parental monitoring score (Week 0)
GroupValue95% CI
Nutrition/Substance Use Prevention4.288± .48584
Substance Use Prevention Only4.2471± .47745
Academic Success Program4.6252± .41436
All Conditions4.3599± .48844
T2 parental monitoring score
GroupValue95% CI
Nutrition/Substance Use Prevention4.5216± .47837
Substance Use Prevention Only4.424± .43793
Academic Success Program4.5574± .38802
All Conditions4.5104± .44107
T3 parental monitoring score
GroupValue95% CI
Nutrition/Substance Use Prevention4.5096± .46168
Substance Use Prevention Only4.4454± .48924
Academic Success Program4.5283± .49091
All Conditions4.4996± .47716
Overall Family Functioning- Parental Involvement Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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 yout

Baseline (T1) parental involvement
GroupValue95% CI
Nutrition/Substance Use Prevention4.178± .54274
Substance Use Prevention Only4.1796± .56556
Academic Success Program4.4319± .49781
All Conditions4.2616± .54475
T2 parental involvement (Week 10-12)
GroupValue95% CI
Nutrition/Substance Use Prevention4.437± .4347
Substance Use Prevention Only4.4277± .36648
Academic Success Program4.5902± .40566
All Conditions4.4866± .41442
T3 parental involvement (Week 24-26)
GroupValue95% CI
Nutrition/Substance Use Prevention4.2609± .5196
Substance Use Prevention Only4.3686± .49051
Academic Success Program4.4788± .51803
All Conditions4.3599± .51801
Acculturation- Mexican Orientation Scale Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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 orientati

Baseline (T1) Mexican oriented scale (MOS)- Parents
GroupValue95% CI
Nutrition/Substance Use Prevention4.4314± .57546
Substance Use Prevention Only4.4418± .55903
Academic Success Program4.3171± .78652
All Conditions4.3967± .64787
T2 Mexican oriented scale (MOS)- Parents
GroupValue95% CI
Nutrition/Substance Use Prevention4.5019± .50063
Substance Use Prevention Only4.4905± .55794
Academic Success Program4.4905± .68682
All Conditions4.4953± .58002
T3 Mexican oriented scale (MOS)- Parents
GroupValue95% CI
Nutrition/Substance Use Prevention4.427± .62828
Substance Use Prevention Only4.5173± .54901
Academic Success Program4.502± .703
All Conditions4.4745± .63436
Acculturation- Anglo Orientation Subscale Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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.

Baseline (T1) Anglo oriented scale (AOS)- Parents
GroupValue95% CI
Nutrition/Substance Use Prevention2.2827± .85561
Substance Use Prevention Only2.3876± 1.10831
Academic Success Program2.3387± 1.05454
All Conditions2.3247± .98075
T2 Anglo oriented scale (AOS)- Parents
GroupValue95% CI
Nutrition/Substance Use Prevention2.3149± .86206
Substance Use Prevention Only2.2714± .96525
Academic Success Program2.2906± 1.04594
All Conditions2.2963± .94736
T3 Anglo oriented scale (AOS)- Parents
GroupValue95% CI
Nutrition/Substance Use Prevention2.3889± .86462
Substance Use Prevention Only2.3033± .96986
Academic Success Program2.4354± 1.10092
All Conditions2.3816± .96834
Multidimensional Acculturative Stress Inventory Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

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.

Baseline (T1) acculturation stress
GroupValue95% CI
Nutrition/Substance Use Prevention1.783± .7705
Substance Use Prevention Only1.8831± .81977
Academic Success Program1.8571± .78178
All Conditions1.8302± .78358
T2 acculturation stress
GroupValue95% CI
Nutrition/Substance Use Prevention1.6521± .67318
Substance Use Prevention Only1.7172± .70137
Academic Success Program1.8738± .88159
All Conditions1.7429± .75921
T3 acculturation stress
GroupValue95% CI
Nutrition/Substance Use Prevention1.5235± .62859
Substance Use Prevention Only1.5014± .63398
Academic Success Program1.6951± .85711
All Conditions1.5746± .71491
Nutrition Outcomes- Fruit Intake Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

NCI Dietary Screener: Change in intake of fruit- estimated cups per day

Baseline (T1) predicted intake of fruit per day (cup equivalents) - Parents
GroupValue95% CI
Nutrition/Substance Use Prevention1.1578± .64193
Substance Use Prevention Only1.0087± .34519
Academic Success Program1.1194± .55524
All Conditions1.1109± .55802
Baseline (T1) predicted intake of fruit per day (cup equivalents) - Youth
GroupValue95% CI
Nutrition/Substance Use Prevention.9929± .55339
Substance Use Prevention Only1.1968± .77707
Academic Success Program1.3499± .94983
All Conditions1.1568± .76773
T2 predicted intake of fruit per day (cup equivalents) - Parents
GroupValue95% CI
Nutrition/Substance Use Prevention1.1115± .52472
Substance Use Prevention Only.9861± .42231
Academic Success Program1.0496± .64964
All Conditions1.0608± .55084
T2 predicted intake of fruit per day (cup equivalents) - Youth
GroupValue95% CI
Nutrition/Substance Use Prevention1.0778± 1.06928
Substance Use Prevention Only.9379± .68743
Academic Success Program1.0637± .67436
All Conditions1.04± .86785
T3 predicted intake of fruit per day (cup equivalents) - Parents
GroupValue95% CI
Nutrition/Substance Use Prevention.9626± .41106
Substance Use Prevention Only.8214± .23419
Academic Success Program.9511± .37812
All Conditions.9227± .3655
T3 predicted intake of fruit per day (cup equivalents) - Youth
GroupValue95% CI
Nutrition/Substance Use Prevention.9062± .52541
Substance Use Prevention Only.8979± .46743
Academic Success Program.8071± .37732
All Conditions.873± .4687
Nutrition Outcomes-vegetables Primary · Week 0 (T1), Week 10-12 (T2), Week 24-26 (T3)

NCI Dietary Screener: Change in intake of vegetables- estimated cups per day

Baseline (T1) predicted intake of vegetables per day (cup equivalents) - Parents
GroupValue95% CI
Nutrition/Substance Use Prevention1.5737± .44437
Substance Use Prevention Only1.5656± .43126
Academic Success Program1.6431± .54488
All Conditions1.5957± .47739
Baseline (T1) predicted intake of vegetables per day (cup equivalents) - Youth
GroupValue95% CI
Nutrition/Substance Use Prevention1.1755± .92976
Substance Use Prevention Only1.0472± .58324
Academic Success Program1.105± .67146
All Conditions1.1233± .77842
T2 predicted intake of vegetables per day (cup equivalents) - Parents
GroupValue95% CI
Nutrition/Substance Use Prevention1.7107± .56475
Substance Use Prevention Only1.4978± .38068
Academic Success Program1.5468± .34581
All Conditions1.6031± .46247
T2 predicted intake of vegetables per day (cup equivalents) - Youth
GroupValue95% CI
Nutrition/Substance Use Prevention1.0538± .6498
Substance Use Prevention Only.9821± .27975
Academic Success Program.9756± .39423
All Conditions1.0134± .51151
T3 predicted intake of vegetables per day (cup equivalents) - Parents
GroupValue95% CI
Nutrition/Substance Use Prevention1.6077± .43995
Substance Use Prevention Only1.5163± .39161
Academic Success Program1.4687± .3251
All Conditions1.5391± .3961
T3 predicted intake of vegetables per day (cup equivalents) - Youth
GroupValue95% CI
Nutrition/Substance Use Prevention1.0941± .47764
Substance Use Prevention Only.9209± .32772
Academic Success Program.9903± .35313
All Conditions1.0175± .41021

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Methods and rationale to assess the efficacy of a parenting intervention targeting diet improvement and substance use prevention among Latinx adolescents.
    Vega-López S, Marsiglia FF, Ayers S, Williams LR, et al · · 2020 · cited 9× · PMID 31843638 · DOI 10.1016/j.cct.2019.105914
  2. Diet Outcomes from a Randomized Controlled Trial Assessing a Parenting Intervention Simultaneously Targeting Healthy Eating and Substance Use Prevention among Hispanic Middle-School Adolescents.
    Vega-López S, Ayers S, Gonzalvez A, Campos AP, et al · · 2023 · cited 2× · PMID 37686822 · DOI 10.3390/nu15173790
  3. Associations between parent-adolescent health-related conversations and mealtime media use among Hispanic families.
    Martinez GM, Vega-López S, Ayers S, Gonzalvez A, et al · · 2024 · PMID 37870808 · DOI 10.1037/fsh0000855

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing