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Family Based Prevention of Alcohol and Risky Sex for Older Teens

Primary Purpose

Alcohol Drinking, Alcohol Intoxication, Alcohol Poison

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smart Choices 4 Teens
Sponsored by
Pacific Institute for Research and Evaluation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

16 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Sites / Locations

  • Brenda Miller

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smart Choices 4 Teens

Control condition

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2018
Last Updated
July 19, 2023
Sponsor
Pacific Institute for Research and Evaluation
Collaborators
Klein Buendel, Inc., University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03521115
Brief Title
Family Based Prevention of Alcohol and Risky Sex for Older Teens
Official Title
Web-based Family Prevention of Alcohol and Risky Sex for Older Teens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
May 28, 2017 (Actual)
Study Completion Date
May 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Institute for Research and Evaluation
Collaborators
Klein Buendel, Inc., University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Intoxication, Alcohol Poison, Alcohol-Related Disorders, Alcohol Impairment, Alcohol Withdrawal, Alcohol Abstinence, Alcohol; Harmful Use, Sex Behavior, Sexual Aggression, Sexual Harassment, Relation, Interpersonal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Participant
Masking Description
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
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smart Choices 4 Teens
Arm Type
Experimental
Arm Description
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
Arm Title
Control condition
Arm Type
No Intervention
Arm Description
This group was provided with websites where information was available regarding the same topics.
Intervention Type
Behavioral
Intervention Name(s)
Smart Choices 4 Teens
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Teens Using Any Alcohol During Past 6 Months
Description
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.
Time Frame
Measured at baseline, 6, 12, & 18 months
Title
Frequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months
Description
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.
Time Frame
Measured at 6, 12, & 18 months
Title
Quantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months
Description
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.
Time Frame
Measured at baseline, 6, 12, & 18 months
Title
Count of Teens Who Were Drunk or Very, Very High During the Past 6 Months
Description
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.
Time Frame
Measured at 6, 12, & 18 months
Title
Frequency of Parental Approval for Teen Drinking (in Moderation)
Description
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.
Time Frame
Measured at baseline, 6, 12, & 18 months
Title
Frequency of Teen- Parent Communications Regarding Sex
Description
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.
Time Frame
Measured at baseline, 6, 12, & 18 months
Title
Frequency of Teen-parent Communications About Specific Sexual Topics
Description
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.
Time Frame
Measured at baseline, 6, 12, & 18 months
Title
Count of Teen-parent Communications Regarding Delaying Sexual Activity
Description
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.
Time Frame
Measured at baseline, 6, 12, & 18 months
Title
Count of Teen-parent Communications Regarding Health Risks Associated With Sex
Description
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.
Time Frame
Past 6, 12, & 18 months
Title
Count of Parental Dating Rules
Description
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.
Time Frame
Measured at baseline, 6, 12, & 18 months
Title
Count of Teens Who Have Ever Had Sex Over Their Lifetime
Description
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.
Time Frame
Measured at baseline, 6, 12, & 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: One parent and the teen both had to enroll in the study. Exclusion Criteria: Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda A Miller, Ph.D.
Organizational Affiliation
Pacific Institute for Research & Evaluation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brenda Miller
City
Berkeley
State/Province
California
ZIP/Postal Code
94704-1365
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30640504
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. Epub 2019 Jan 14.
Results Reference
result
PubMed Identifier
29172702
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: 10.1177/0163278717742189. Online ahead of print.
Results Reference
result
PubMed Identifier
34128818
Citation
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.
Results Reference
result
Links:
URL
https://pediatrics.jmir.org/2021/2/e19114
Description
Efficacy of a Web-Based Intervention (Smart Choices 4 Teens) for Facilitating Parent-Adolescent Communication About Relationships and Sexuality: Randomized Controlled Trial

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Family Based Prevention of Alcohol and Risky Sex for Older Teens

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