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Family Based Prevention of Alcohol and Risky Sex for Older Teens

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ClinicalTrials.gov Identifier: NCT03521115
Recruitment Status : Completed
First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Sponsor:
Collaborators:
Klein Buendel, Inc.
University of New Mexico
Information provided by (Responsible Party):
Brenda Miller, Pacific Institute for Research and Evaluation

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Smart Choices 4 Teens Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 851 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Participant)
Masking Description: Parents and Teens were either assigned to the full intervention or provided with didactic materials available on the internet.
Primary Purpose: Prevention
Official Title: Web-based Family Prevention of Alcohol and Risky Sex for Older Teens
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : May 28, 2017
Actual Study Completion Date : May 28, 2017

Arm Intervention/treatment
Experimental: Smart Choices 4 Teens
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.
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.

No Intervention: Control condition
This group was provided with websites where information was available regarding the same topics.



Primary Outcome Measures :
  1. Change in alcohol use over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Change in prevalence of use ever, past 6 months, past 30 days

  2. Change in sexual behaviors over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Change in prevalence from baseline to post-intervention time periods


Secondary Outcome Measures :
  1. Change in marijuana use over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Change in prevalence of use from baseline to post-intervention time periods

  2. Change in stimulant use over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Change in prevalence of use from baseline to post-intervention time periods

  3. Change in prescription drug use for nonmedical purposes over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Change in prevalence of use from baseline to post-intervention time periods

  4. Changes in parent-teen (general)communications over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Changes in the quality of general communication from baseline to post-intervention time periods

  5. Changes in parent-teen communications regarding teen alcohol use over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Count of topics covered (consequences of drinking, expectations for teen alcohol use, refusal strategies, rules) from baseline to post-intervention time periods

  6. Changes in parent-teen discussions about safe drinking for teens over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Changes in parental approval of teen drinking in moderation or under certain conditions, from baseline to post-intervention time periods

  7. Changes in parent-teen communications about social host laws over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Changes in the prevalence/frequency of communications about the laws from baseline to post-intervention time periods

  8. Changes in parent-teen communications regarding sexual behaviors/relationships over time [ Time Frame: Baseline, 6, 12, and 18 months ]
    Count of the topics covered (sexual expectancies, rules, negative consequences, strategies for refusal) from baseline to post-intervention time periods



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521115


Locations
United States, California
Prevention Research Center
Oakland, California, United States, 94612
Sponsors and Collaborators
Pacific Institute for Research and Evaluation
Klein Buendel, Inc.
University of New Mexico
Investigators
Principal Investigator: Brenda A Miller, Ph.D. Pacific Institute for Research & Evaluation

Responsible Party: Brenda Miller, Senior Scientist, Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier: NCT03521115     History of Changes
Other Study ID Numbers: AA020977
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aggression
Alcohol Drinking
Alcohol-Related Disorders
Alcoholic Intoxication
Alcohol Abstinence
Behavioral Symptoms
Drinking Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs