Family Based Prevention of Alcohol and Risky Sex for Older Teens

NCT ID: NCT03521115

Last Updated: 2023-07-27

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-01

Study Completion Date

2017-05-28

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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

Study Groups

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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. Numbers are provided for the number of families

Group Type EXPERIMENTAL

Smart Choices 4 Teens

Intervention Type BEHAVIORAL

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.

Control condition

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non-English speaking
Minimum Eligible Age

16 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Klein Buendel, Inc.

INDUSTRY

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role collaborator

Pacific Institute for Research and Evaluation

OTHER

Sponsor Role lead

Responsible Party

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Brenda Miller

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brenda A Miller, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pacific Institute for Research & Evaluation

Locations

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Brenda Miller

Berkeley, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30640504 (View on PubMed)

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.

Reference Type RESULT
PMID: 29172702 (View on PubMed)

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.

Reference Type RESULT
PMID: 34128818 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pediatrics.jmir.org/2021/2/e19114

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

Other Identifiers

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AA020977

Identifier Type: -

Identifier Source: org_study_id

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