Clinical trial NCT03440463: Alcohol Health Education With Personalized Feedback Boosters
Official title: Alcohol Health Education With Personalized Feedback Boosters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: College Student Drinking
Lead sponsor: Old Dominion University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-02-22
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol Consumption at 3 Months Post-intervention
timeFrame: Past 30 days (3 months post-intervention)
Secondary outcomes:
measure: Alcohol-related Consequences 3 Months Post-intervention
timeFrame: Past 30 days (3 months post-intervention)
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Old Dominion University
state: Virginia
Study officials:
affiliation: Old Dominion University
name: Abby L Braitman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):635-647. doi: 10.1037/adb0000755. Epub 2021 Jun 3.