- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07086508
- Original Trial
Examining an Intervention to Reduce High School Drinking
A Randomized Clinical Trial: Examining the Efficacy of eCHECKUP TO GO Combined With a Brief Parent-based Intervention to Reduce High School Student Drinking
Study Overview
Status
Intervention / Treatment
Detailed Description
Prevalence rates of high school alcohol use suggest 61.6% of high school students have used alcohol by their senior year and 1 in 3 students report alcohol use past 30-days. High school risky drinking is associated with negative consequences including impaired neurocognitive functioning, academic problems, hangovers, passing out, unwanted sex, dating violence, suicide attempts, illicit drug use, riding with impaired drivers, and impaired driving.
While past research supports the efficacy of interventions in delaying the initiation of alcohol use implemented in middle school and early high school, research shows drinking by older high schoolers is problematic and interventions for older high schoolers remain limited. Implementation with high schoolers has always been difficult to sustain following the completion of the grant funding period due to large costs associated with personnel to hire, train, and supervise teachers and staff to implement interventions with fidelity. As an alternative, brief web-based personalized feedback interventions that do not require staffing or costs to implement to large numbers of students have shown promise (e.g., eCHECKUP TO GO; eCTG). Our preliminary work, including our funded NIAAA R21 study, supporting this proposal has shown eCTG is efficacious in changing normative perceptions of peer drinking frequency and drunkenness, positive alcohol expectancies, and reducing both alcohol use and consequences among high school students. The proposed research will expand on these findings by conducting a randomized controlled trial using the eCHECKUP TO GO (eCTG) alone and combined with an efficacious brief electronic-Parent-Based Intervention on a nationally representative sample of high school juniors and seniors.
The design is a four-arm RCT: eCTG, eCTG+, Parent-Only, and Control. Data collection will occur across 5 waves (pre-intervention baseline, 3-, 6-, 9-, 12- month follow-ups) for all arms. In all arms there is one wave for parents (3-month only).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Binghamton, New York, United States, 13902
- Binghamton University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Teen is aged 15-18/Parent has a teen aged 15-18
- Parent and teen both consent (forming a dyad testing unit)
- They are part of Ipsos' Knowledge Panel
Exclusion Criteria:
- Outside of the teen age range/Parent does not have a teen aged 15-18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: e-CHECKUP TO GO (eCTG)
A brief, web-based program designed by San Diego State University to reduce high-risk drinking by providing personalized normative feedback regarding alcohol use, risk factors, and risks associated with drinking and accurate information about alcohol
|
A brief, web-based program designed by San Diego State University to reduce high-risk drinking by providing personalized normative feedback regarding alcohol use, risk factors, and risks associated with drinking and accurate information about alcohol.
|
|
Experimental: e-Parent Intervention and eCTG (eCTG+)
The eCTG+ is a combination of the eCTG and the e-Parent Intervention, which is an electronic handbook developed by Rob Turrisi to guide parents in discussing drinking, behaviors, and consequences with their teens.
|
A brief, web-based program designed by San Diego State University to reduce high-risk drinking by providing personalized normative feedback regarding alcohol use, risk factors, and risks associated with drinking and accurate information about alcohol.
The e-Parent Intervention, which is an electronic handbook developed by Rob Turrisi to guide parents in discussing drinking, behaviors, and consequences with their teens.
|
|
Experimental: e-Parent Intervention
The e-Parent Intervention, which is an electronic handbook developed by Rob Turrisi to guide parents in discussing drinking, behaviors, and consequences with their teens.
|
The e-Parent Intervention, which is an electronic handbook developed by Rob Turrisi to guide parents in discussing drinking, behaviors, and consequences with their teens.
|
|
No Intervention: Control
No intervention is provided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Examine changes in alcohol use
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
A standard drink definition will be provided, indicating that a standard drink consists of 12 oz. of beer or wine cooler, 8.5 oz. of malt liquor, 4 oz. of wine, or 1.5 oz. of hard liquor.
Using the Daily Drinking Questionnaire (DDQ), participants will indicate how many drinks they consumed on each day of a typical week during the past month.
Participants will also be asked peak drinks and hours spent drinking during the occasion they drank the most during the past month.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Examine Changes in Consequences of Alcohol Use
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
Alcohol-related consequences (e.g., said or done embarrassing things, blackout) from the past three months will be measured using the established Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ).
Response options will be measured on a 7-point scale ranging from (0) no, not in the past year to (6) 11 or more times in the past three months.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Examine Changes in Parental Communications
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
General Communication (e.g., my mother/father is there for me when I want to talk) will be assessed separately for mothers and fathers based on level of agreement on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
|
Examine Changes in Alcohol Use Expectancies
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
Expectancies for using alcohol (e.g., I will feel badly about myself because of my drinking) will be measured.
Responses will be recorded using 7-point scale ranging from (1) strongly disagree to (7) strongly agree.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
|
Examine Changes in General Parental Practices
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
General Parenting Practices (e.g., if I had a personal problem I could ask my mother/father for help) will be assessed separately for mothers and fathers based on level of agreement on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
|
Examine Changes in Peer Injunctive Norms
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
Perceived peer injunctive norms will be measured by indicating the level of approval participants' closest friends would have from a list of items (e.g., drinking alcohol every weekend) on a 7-point scale ranging from (1) strongly disapprove to (7) strongly approve.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
|
Examine Changes in Parental Communication
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
Parental communication about alcohol use will be assessed separately for mothers and fathers.
Participants will be asked whether their parent discussed these topics (yes/no) with them within the past three months.
Items include topics such as "the importance of not being pressured to drink to fit it".
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
|
Examine Changes in Parental Monitoring
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
Parental monitoring (e.g., my mother/father tries to know about my drinking) will be assessed separately for mothers and fathers based on level of agreement on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
|
Examine Changes in Parental Rules about Underage Drinking (Permissiveness)
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
Parental permissiveness of underage drinking will be assessed using six items (e.g., I am allowed to drink alcohol on special occasions), based on level of agreement on a 7-point scale ranging from (1) strongly disagree to (7) strongly agree.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
|
Examine Changes in Peer Descriptive Norms
Time Frame: Baseline, 3 month, 6 month, 9 month, 12 month
|
Perceived peer descriptive norms of drinking will be measured using the Daily Drinking Questionnaire (DDQ) by assessing how much alcohol, on average, participants' closest friends drink each day of the week.
|
Baseline, 3 month, 6 month, 9 month, 12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nadine Mastroleo, PhD, Binghamton University
Publications and helpful links
General Publications
- Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available.
- Read JP, Kahler CW, Strong DR, Colder CR. Development and preliminary validation of the young adult alcohol consequences questionnaire. J Stud Alcohol. 2006 Jan;67(1):169-77. doi: 10.15288/jsa.2006.67.169.
- van der Vorst H, Engels RC, Meeus W, Dekovic M. Parental attachment, parental control, and early development of alcohol use: a longitudinal study. Psychol Addict Behav. 2006 Jun;20(2):107-16. doi: 10.1037/0893-164X.20.2.107.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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