Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03440463
Other study ID # 14-221
Secondary ID K01AA023849
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 11, 2017
Est. completion date April 4, 2018

Study information

Verified date May 2023
Source Old Dominion University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention (Braitman & Henson, 2016). Although promising, the booster incorporated in the study needs further empirical refinement. In addition, the intervention originally tested (Alcohol 101 Plus) is no longer widely available. The current project seeks to build on past progress by further developing and refining the booster. In addition, it examines the utility of the booster after a different, widely-used, empirically-supported online intervention (e-checkup to go). e-checkup to go directly provides personalized normative feedback, but not protective strategies, the two components of the examined booster. Hence, the current study compares the reinforcing content (normative feedback) to the combination of reinforcing and novel content (norms PLUS protective strategies). There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 does not receive a booster email. Condition 2 receives an emailed booster with normative feedback only. Condition 3 receives an emailed booster with normative feedback plus protective strategies. The aims of the current study are as follows: Aim 1: Examine if novel feedback in the form of protective strategies enhances the reinforcing normative feedback received via booster email (i.e., a comparison of reinforcing normative feedback only versus reinforcing normative feedback plus novel protective strategy feedback). Aim 2: Examine previously identified potential moderators and mediators of reductions in alcohol use and related problems.


Description:

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from frequent or heavy alcohol use can be mild (e.g., hangovers, missed classes), moderate (e.g., poor grades, damaged relationships), or severe (e.g., assault, even death). Given the potentially dangerous consequences, reducing alcohol use and associated problems is a major health priority. Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. The benefits of online interventions include cost-effectiveness and ease of administration, plus they offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. Although post-intervention boosters have been shown to be effective for individuals seeking treatment for alcohol-related injuries in emergency medical settings, limited studies have investigated the efficacy of boosters for college students who have received alcohol interventions. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention, while at the same time maintaining low cost and easy dissemination (Braitman & Henson, 2016). Although promising, the booster incorporated in the study needs further empirical refinement. In addition, the intervention originally tested (Alcohol 101 Plus) is no longer widely available. The current project seeks to build on past progress reducing the gap between online and more efficacious in-person interventions. The current study further develops and refines the booster to identify optimal administration for maximum efficacy. In addition, it examines the utility of the booster after a different, widely-used, empirically-supported online intervention (e-checkup to go). The new intervention (e-checkup to go) directly provides personalized normative feedback, but not protective strategies, the two components of the examined booster. Hence, the current study compares the reinforcing content (personalized normative feedback) to the combination of reinforcing and enhancing/novel content (norms PLUS protective strategies). This addresses a major question of the relatively new booster literature for college drinking regarding if reinforcing content is sufficient to boost efficacy versus if novel information is an important supplementary component. There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 does not receive a booster email. Condition 2 receives an emailed booster with normative feedback only. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback. The booster content of tailored norms alone (reinforcing content) may alone be efficacious, or receiving tailored norms and strategies students can use to reduce consumption and related harm (protective behavioral strategies; novel content) may enhance the effect. Thus, the aims of the current study are as follows: Aim 1: Examine if novel feedback in the form of protective strategies enhances the reinforcing tailored normative feedback received via booster email (i.e., a comparison of reinforcing normative feedback only versus reinforcing normative feedback plus novel protective strategy feedback). Hypothesis 1a: Both groups receiving emailed feedback will reduce drinking and alcohol-related problems as compared to the intervention-only control condition. Hypothesis 1b: Reductions in drinking and problems will be stronger for those who receive emails with novel protective strategy feedback rather than reinforcing norms alone. Aim 2: Examine previously identified potential moderators and mediators of reductions in alcohol use and related problems (i.e., gender, norms, strategies).


Recruitment information / eligibility

Status Completed
Enrollment 528
Est. completion date April 4, 2018
Est. primary completion date April 4, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: - Current college students at the sponsor institution at the time of enrollment - Between the ages of 18 and 24 - Consumed at least standard drink of alcohol in the past 2 weeks Exclusion Criteria: - Under age of 18 - Over age of 24 - Not a college student - Did not drink alcohol in the past 2 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
e-checkup to go
The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Norms-only booster
Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare.
Norms-plus-Strategies booster
Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare. These booster emails will also contain reminders of strategies they can use to protect themselves from alcohol-related harm, both ones they've reported using in the past and others they might consider using in the future.

Locations

Country Name City State
United States Old Dominion University Norfolk Virginia

Sponsors (2)

Lead Sponsor Collaborator
Abby Braitman National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Braitman AL, Strowger M, Lau-Barraco C, Shipley JL, Kelley ML, Carey KB. Examining the added value of harm reduction strategies to emailed boosters to extend the effects of online interventions for college drinkers. Psychol Addict Behav. 2022 Sep;36(6):63 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol Consumption at 3 Months Post-intervention Participant self-reported number of standard drinks consumed by participant in a typical week. Past 30 days (3 months post-intervention)
Secondary Alcohol-related Consequences 3 Months Post-intervention Assessed via the "Young Adult Alcohol Consequences Questionnaire" (Read et al., 2006). Participants indicate if they experienced an alcohol-related problem with a yes (=1) or no (=0). Scores are created by summing across all 48 items (range 0 to 48), where higher scores indicate experiencing more alcohol-related consequences/problems.
Read, J. P., Kahler, C. W., Strong, D. R., & Colder, C. R. (2006). Development and preliminary validation of the young adult alcohol consequences questionnaire. Journal of Studies on Alcohol, 67, 169-177. doi:10.15288/jsa.2006.67.169
Past 30 days (3 months post-intervention)
See also
  Status Clinical Trial Phase
Recruiting NCT03218670 - Your Health in On Click N/A
Completed NCT04453007 - Timing Personalized Feedback After Alcohol Health Education Phase 1/Phase 2
Recruiting NCT03510728 - Efficacy and Mechanisms of Technology-based Behavioral Interventions N/A
Completed NCT03930524 - Adaptive Preventive Intervention for College Alcohol Use N/A
Completed NCT03433794 - Alcohol Health Education Among College Drinkers Phase 1
Completed NCT03440476 - Personalized Booster Feedback After Alcohol Health Education Phase 1/Phase 2
Enrolling by invitation NCT05107284 - Personalized Feedback After Alcohol Health Education for Members of Greek Life (GREEK Study) Phase 1/Phase 2