Clinical trial NCT03521115: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Pacific Institute for Research and Evaluation
Sponsor class: OTHER
Collaborators: name: Klein Buendel, Inc.
name: University of New Mexico
First posted: 2018-05-11
Enrollment: 411
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Number of Teens Using Any Alcohol During Past 6 Months
timeFrame: Measured at baseline, 6, 12, & 18 months
measure: Frequency of Teen Alcohol Use Over Most Recent 30 Days Within Past 6 Months
timeFrame: Measured at 6, 12, & 18 months
measure: Quantity of Alcohol Consumed by Teens on Drinking Days for the Most Recent 30 Days Within the Past Six Months
timeFrame: Measured at baseline, 6, 12, & 18 months
measure: Count of Teens Who Were Drunk or Very, Very High During the Past 6 Months
timeFrame: Measured at 6, 12, & 18 months
measure: Frequency of Parental Approval for Teen Drinking (in Moderation)
timeFrame: Measured at baseline, 6, 12, & 18 months
measure: Frequency of Teen- Parent Communications Regarding Sex
timeFrame: Measured at baseline, 6, 12, & 18 months
measure: Frequency of Teen-parent Communications About Specific Sexual Topics
timeFrame: Measured at baseline, 6, 12, & 18 months
measure: Count of Teen-parent Communications Regarding Delaying Sexual Activity
timeFrame: Measured at baseline, 6, 12, & 18 months
measure: Count of Teen-parent Communications Regarding Health Risks Associated With Sex
timeFrame: Past 6, 12, & 18 months
measure: Count of Parental Dating Rules
timeFrame: Measured at baseline, 6, 12, & 18 months
measure: Count of Teens Who Have Ever Had Sex Over Their Lifetime
timeFrame: Measured at baseline, 6, 12, & 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Brenda Miller
state: California
Study officials:
affiliation: Pacific Institute for Research & Evaluation
name: Brenda A Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.