NCT03521115

Brief Summary

An online, interactive web-based program for older teens and their parents is designed to address teen alcohol use and teen relationships. The parent-teen dyad both participate in the web-based program and engage in off-line discussion activities. This intervention promotes communication skills, refusal skills, and helps teens consider how to make healthy choices. A total of 411 family dyads (one parent, one teen) were recruited.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 12, 2021

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

4.2 years

First QC Date

April 16, 2018

Results QC Date

July 6, 2021

Last Update Submit

July 19, 2023

Conditions

Outcome Measures

Primary Outcomes (11)

  • Number of Teens Using Any Alcohol During Past 6 Months

    Have you had a drink of alcohol in the past 6 months? (A drink is a glass of wine, a can of beer, a wine cooler, a shot glass of liquor, or a mixed drink). (Response category yes=1/no=0). Range is 0-1. More frequent drinking is a worse outcome.

    Measured at baseline, 6, 12, & 18 months

  • Frequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months

    Over the past 30 days, how many times have you had a drink of alcohol? (response categories: 0=none, 1=once, 2=2-3 times, 3= once a week, 4=2-3 times a week. Range is 0-4.Higher score is more frequent drinking and a worse outcome.

    Measured at 6, 12, & 18 months

  • Quantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months

    Over the past 30 days, how many drinks did you usually have on days you drank? (response categories: 0= less than one, 1, 2, 3, 4, 5, 6, 7= more than six). Range is 0-7. Higher scores represent more drinking and worse outcome.

    Measured at baseline, 6, 12, & 18 months

  • Count of Teens Who Were Drunk or Very, Very High During the Past 6 Months

    Over the past 6 months, how many times have you gotten drunk or very, very high on alcohol? (Response categories: 0=none, 1=once a month, 2=2-3 times a month, 3=once a week, 4= 2-3 times a week, 5=daily or almost daily). Range is 0-5. Higher score represents more drunkenness and a worse outcome.

    Measured at 6, 12, & 18 months

  • Frequency of Parental Approval for Teen Drinking (in Moderation)

    How often have you and your parent talked about drinking in moderation is okay (Response categories 1=Never, 2=Occasionally, 3=Sometimes, 4= Often, 5 = Very often). Range is 1-5 and higher scores means more parental approval of teen drinking and is a worse outcome.

    Measured at baseline, 6, 12, & 18 months

  • Frequency of Teen- Parent Communications Regarding Sex

    Overall, how often you have talked to your parent about sex? (1=Never, 2=Occasionally, 3=Sometimes, 4=Often, 5= Very often). Range 1-5. Higher scores represent a better outcome.

    Measured at baseline, 6, 12, & 18 months

  • Frequency of Teen-parent Communications About Specific Sexual Topics

    Average frequency created across 4 different sex topics (i. how being in a relationship might divert me from achieving my goals at school, ii. how embarrassing it would be if I caught an STI -sexually transmitted infection, iii. sexual relationships can impact health, iv. how pregnancy would be embarassing) with responses being never=1, occasionally=2, sometimes=3, often=4, very often=5 for a full range of 1-5. Across the 4 different sex topics the sums ranged from 4-20 and average was created by dividing the score by 4, with higher scores indicating more both topics and higher frequency of discussions taking place for a final full range of 1-5.

    Measured at baseline, 6, 12, & 18 months

  • Count of Teen-parent Communications Regarding Delaying Sexual Activity

    Communications regarding delaying sex based upon three questions with yes=1/no=0 responses summed: Have your parents told you that (i)you should not have sex, (ii)you should not be in a serious relationship while still in high school, (iii)you should not have sex because your religion or values forbid sex outside of marriage. Higher scores indicate more communications about delaying sex. Range is 0-3. Higher scores represent a better outcome.

    Measured at baseline, 6, 12, & 18 months

  • Count of Teen-parent Communications Regarding Health Risks Associated With Sex

    Parent-teen communications score regarding health risks with sex were based upon two items: discussion that sex can result in pregnancy (y=1/n=0) and sex can result in sexually transmitted infections (y=1/n=0). Range is 0-2. Higher scores represent a better outcome.

    Past 6, 12, & 18 months

  • Count of Parental Dating Rules

    Parental rules regarding dating were based upon summing the yes (=1) response to 15 possible rules: parents must meet date, check in/call during date, parents must know destination, parents must know change of plans, address and phone number needed for parties, no dates on school nights, no sex, no sigle dates, curfew, only agreed upon locations, use good judgment, be gentleman/lady, leave if uncomfortable (y=1/n=0). Range is 0-15. Higher scores represent better outcomes.

    Measured at baseline, 6, 12, & 18 months

  • Count of Teens Who Have Ever Had Sex Over Their Lifetime

    Have you ever had sex (vaginal, oral, or anal)? (responses were yes=1/no=0). Range was 0-1. Higher score is worse outcome risk.

    Measured at baseline, 6, 12, & 18 months

Study Arms (2)

Smart Choices 4 Teens

EXPERIMENTAL

A web-based intervention consisting of 3 main components (Communication, Alcohol, Relationships) provided to both parents and teens was completed by parents and teens individually. At the end of each component, discussion guidelines were given to promote communications and to offer skill building practices between parent and teen regarding the component topic. Both the parent and teen were required to complete the component and discussion before moving to the next component. Numbers are provided for the number of families

Behavioral: Smart Choices 4 Teens

Control condition

NO INTERVENTION

This group was provided with websites where information was available regarding the same topics.

Interventions

This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other.

Smart Choices 4 Teens

Eligibility Criteria

Age16 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • One parent and the teen both had to enroll in the study.

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brenda Miller

Berkeley, California, 94704-1365, United States

Location

Related Publications (3)

  • Byrnes HF, Miller BA, Grube JW, Bourdeau B, Buller DB, Wang-Schweig M, Woodall WG. Prevention of alcohol use in older teens: A randomized trial of an online family prevention program. Psychol Addict Behav. 2019 Feb;33(1):1-14. doi: 10.1037/adb0000442. Epub 2019 Jan 14.

  • Wang-Schweig M, Miller BA, Buller DB, Byrnes HF, Bourdeau B, Rogers V. Using Panel Vendors for Recruitment Into a Web-Based Family Prevention Program: Methodological Considerations. Eval Health Prof. 2017 Jan 1:163278717742189. doi: 10.1177/0163278717742189. Online ahead of print.

  • Bourdeau B, Miller BA, Byrnes HF, Woodall WG, Buller DB, Grube JW. Efficacy of a Web-Based Intervention (Smart Choices 4 Teens) for Facilitating Parent-Adolescent Communication About Relationships and Sexuality: Randomized Controlled Trial. JMIR Pediatr Parent. 2021 Jun 15;4(2):e19114. doi: 10.2196/19114.

Related Links

MeSH Terms

Conditions

Alcohol DrinkingAlcoholic IntoxicationAlcohol-Related DisordersAlcohol AbstinenceSexual BehaviorSexual Harassment

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersSocial Behavior

Limitations and Caveats

This sample was drawn from a nationwide sample of families compiled by panel vendors. Smart Choices 4 Teens is family-based, designed to promote healthy choices by teens related to alcohol use and relationships. It is not a treatment program.

Results Point of Contact

Title
Dr. Brenda A. Miller
Organization
PIRE

Study Officials

  • Brenda A Miller, Ph.D.

    Pacific Institute for Research & Evaluation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Parents and Teens were either assigned to the full intervention or provided with didactic materials available on the internet. Family is considered the level of participant
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 11, 2018

Study Start

April 1, 2013

Primary Completion

May 28, 2017

Study Completion

May 28, 2017

Last Updated

July 27, 2023

Results First Posted

October 12, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations