Family Based Prevention of Alcohol and Risky Sex for Older Teens

Alcohol Drinking Clinical Trial

Official title:

Web-based Family Prevention of Alcohol and Risky Sex for Older Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521115
• Other study ID #: AA020977
• Status: Completed
• Phase: N/A
• Start date: April 1, 2013
• Est. completion date: May 28, 2017

Study information

• Verified date: July 2023
• Source: Pacific Institute for Research and Evaluation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This purpose of this study is to develop an interactive, web-based prevention program for parents and older teens that focuses on teen use of alcohol and teen relationships. The study is designed as a randomized controlled trial.

Specific Aim 1: To adapt two parent-based prevention strategies (Family Matters and Parent Handbook) to provide a family-based approach for addressing older teen alcohol related risk behaviors and sexual risk behaviors and sex in combination with alcohol use (hereafter called alcohol and/or sexual risk behaviors) using the web as the program delivery mode.

Specific Aim 2: To test whether exposure to the program leads to expected changes in targeted teen beliefs and behaviors, including reductions in alcohol and/or sexual risk behaviors.

Specific Aim 3: To examine whether program effects on teen alcohol and/or sexual risk behaviors are mediated through changes in intermediate program targeted beliefs (parents and teen) and behaviors (e.g., parent-teen--communication). Program fidelity and process measures may also mediate these outcomes.

Phase I integrates and adapts the two parent-based approaches and creates a web-based interactive delivery of materials. Expert panels, focus groups, and usability assessments will inform the process. Phase II is an RCT with 400 families with the web-based intervention. Surveys will be conducted at baseline, and for three follow-up periods (6, 12, & 18 months). Analyses will examine teen outcomes related to alcohol and/or sexual risk behaviors. Changes in mediators directly impacted by the program for both teens and parents will be examined. Process and fidelity information will be collected and assessed.

A web-based prevention strategy supporting parents and teens, is significant and timely. Parents and teens will use the internet to make health decisions. This program is uniquely different from other programs be-cause it addresses teens at high risk for alcohol and/or sexual risk behaviors. Further, the strategy involves both parents and teens through an interactive framework. The approach utilizes the strengths of Family Matters which promotes specific exercises and activities between parents and teens and the strengths of the Parent Handbook which addresses issues of importance to this age range.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: May 28, 2017
• Est. primary completion date: May 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-English speaking

Related Conditions & MeSH terms

• Aggression
• Alcohol Abstinence
• Alcohol Drinking
• Alcohol Impairment
• Alcohol Intoxication
• Alcohol Poison
• Alcohol Withdrawal
• Alcohol-Related Disorders
• Alcohol; Harmful Use
• Alcoholic Intoxication
• Relation, Interpersonal
• Sex Behavior
• Sexual Aggression
• Sexual Harassment

Intervention

Behavioral:
• Smart Choices 4 Teens
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.

Locations

Country	Name	City	State
United States	Brenda Miller	Berkeley	California

Sponsors (3)

Lead Sponsor	Collaborator
Pacific Institute for Research and Evaluation	Klein Buendel, Inc., University of New Mexico

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 P — View Citation

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. Epu — View Citation

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: 10.1177/01632787177421 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Efficacy of a Web-Based Intervention (Smart Choices 4 Teens) for Facilitating Parent-Adolescent Communication About Relationships and Sexuality: Randomized Controlled Trial