Alcohol Drinking Clinical Trial
Official title:
Web-based Family Prevention of Alcohol and Risky Sex for Older Teens
NCT number | NCT03521115 |
Other study ID # | AA020977 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2013 |
Est. completion date | May 28, 2017 |
Verified date | July 2023 |
Source | Pacific Institute for Research and Evaluation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Brenda Miller | Berkeley | California |
Lead Sponsor | Collaborator |
---|---|
Pacific Institute for Research and Evaluation | Klein Buendel, Inc., University of New Mexico |
United States,
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
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 |
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