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Alcohol Health Education With Personalized Feedback Boosters

Alcohol Health Education With Personalized Feedback Boosters

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03440463
Enrollment
528
Registered
2018-02-22
Start date
2017-04-11
Completion date
2018-04-04
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

College Student Drinking

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).

Interventions

BEHAVIORALe-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.

BEHAVIORALNorms-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.

BEHAVIORALNorms-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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Abby Braitman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The intervention is an online program, not an individual, so masking is not necessary. Similarly, the same online survey is deployed in all follow-up assessments regardless of condition, and data are not collected by individuals, so masking is not necessary.

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol Consumption at 3 Months Post-interventionPast 30 days (3 months post-intervention)Participant self-reported number of standard drinks consumed by participant in a typical week.

Secondary

MeasureTime frameDescription
Alcohol-related Consequences 3 Months Post-interventionPast 30 days (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

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention-only Control
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains only a reminder to participate in follow-up surveys. 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.
201
Intervention Plus Norms-only Booster
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use. 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.
163
Intervention Plus Norms-plus-Strategies Booster
Participants navigate through e-checkup to go, the well-established alcohol intervention. Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use. It also includes reported harm reduction strategies, and other strategies they might consider. e-checkup to go: The e-checkup to go 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 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-plus-Strategies booster: Booster emails contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, and their own reported consumption. These emails 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.
164
Total528

Baseline characteristics

CharacteristicIntervention Plus Norms-plus-Strategies BoosterTotalIntervention Plus Norms-only BoosterIntervention-only Control
Age, Continuous20.02 years
STANDARD_DEVIATION 1.74
19.85 years
STANDARD_DEVIATION 1.65
19.75 years
STANDARD_DEVIATION 1.53
19.80 years
STANDARD_DEVIATION 1.66
Alcohol-related consequences (problems)6.28 score on a scale
STANDARD_DEVIATION 7.17
6.19 score on a scale
STANDARD_DEVIATION 6.91
6.07 score on a scale
STANDARD_DEVIATION 7.05
6.21 score on a scale
STANDARD_DEVIATION 6.59
Drinking days per typical week (frequency)2.23 drinking days per week
STANDARD_DEVIATION 1.32
2.15 drinking days per week
STANDARD_DEVIATION 1.24
1.96 drinking days per week
STANDARD_DEVIATION 1.13
2.24 drinking days per week
STANDARD_DEVIATION 1.25
Drinks per typical week (quantity)8.05 drinks per week
STANDARD_DEVIATION 10.32
7.69 drinks per week
STANDARD_DEVIATION 8.71
6.72 drinks per week
STANDARD_DEVIATION 7.14
8.18 drinks per week
STANDARD_DEVIATION 8.41
Ethnicity (NIH/OMB)
Hispanic or Latino
145 Participants467 Participants146 Participants176 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants58 Participants17 Participants25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants3 Participants0 Participants0 Participants
Highest drinking occasion in a typical week (peak)3.71 drinks per day
STANDARD_DEVIATION 3.2
3.76 drinks per day
STANDARD_DEVIATION 2.93
3.48 drinks per day
STANDARD_DEVIATION 2.55
4.01 drinks per day
STANDARD_DEVIATION 2.98
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
9 Participants33 Participants7 Participants17 Participants
Race (NIH/OMB)
Black or African American
77 Participants233 Participants76 Participants80 Participants
Race (NIH/OMB)
More than one race
18 Participants63 Participants25 Participants20 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants33 Participants5 Participants17 Participants
Race (NIH/OMB)
White
49 Participants166 Participants50 Participants67 Participants
Sex/Gender, Customized
Female
113 Participants378 Participants115 Participants150 Participants
Sex/Gender, Customized
Male
51 Participants149 Participants47 Participants51 Participants
Sex/Gender, Customized
Other
0 Participants1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 2010 / 1630 / 164
other
Total, other adverse events
0 / 2010 / 1630 / 164
serious
Total, serious adverse events
0 / 2010 / 1630 / 164

Outcome results

Primary

Alcohol Consumption at 3 Months Post-intervention

Participant self-reported number of standard drinks consumed by participant in a typical week.

Time frame: Past 30 days (3 months post-intervention)

Population: Participants who completed the follow-up survey 3 months post-intervention.

ArmMeasureValue (MEAN)Dispersion
Intervention-only ControlAlcohol Consumption at 3 Months Post-intervention4.08 drinks per weekStandard Deviation 5.81
Intervention Plus Norms-only BoosterAlcohol Consumption at 3 Months Post-intervention4.15 drinks per weekStandard Deviation 5.71
Intervention Plus Norms-plus-Strategies BoosterAlcohol Consumption at 3 Months Post-intervention4.89 drinks per weekStandard Deviation 7.68
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

Time frame: Past 30 days (3 months post-intervention)

Population: Participants who completed the follow-up survey 3 months post-intervention.

ArmMeasureValue (MEAN)Dispersion
Intervention-only ControlAlcohol-related Consequences 3 Months Post-intervention3.27 score on a scaleStandard Deviation 5.68
Intervention Plus Norms-only BoosterAlcohol-related Consequences 3 Months Post-intervention2.37 score on a scaleStandard Deviation 3.73
Intervention Plus Norms-plus-Strategies BoosterAlcohol-related Consequences 3 Months Post-intervention2.67 score on a scaleStandard Deviation 4.11

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026