An interventional study of Gamified Personalized Normative Feedback in College Drinking, Underage Drinking and Alcohol Use Disorder, sponsored by Loyola Marymount University. Completed at 1 site in United States. Open to participants aged 18 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Loyola Marymount University · Not applicable, Interventional, and Prevention
Personalized Normative Feedback (PNF), the most widely-used college alcohol intervention approach, suffers from several limitations innovatively remedied in the current proposal through CampusGANDR, a smartphone-based app for college students that delivers alcohol-related PNF within a weekly game centered around testing first-year students' perceptions about the attitudes and behaviors of their peers in a variety of campus-relevant domains. Five pilot studies suggest that CampusGANDR will be significantly more effective at correcting students' normative misperceptions and reducing their alcohol use than standard PNF, especially among heavier-drinking students and those with greater exposure to alcohol on social media, and that these larger effects are driven by the significantly decreased psychological reactance experienced by students when viewing feedback as part of a game about college life rather than as part of an alcohol-focused program. The current project seeks to 1) evaluate the efficacy of CampusGANDR in a large-scale multi-site trial, 2) identify the optimal dosage of alcohol feedback to deliver within CampusGANDR for correcting norms and reducing alcohol use across 12 weeks of gameplay among non-drinking, moderate-drinking, and heavy-drinking students, 3) examine person-level moderators of these effects, and 4) evaluate CampusGANDR engagement and sustainability among students who play voluntarily but are not involved in the randomized controlled trial.
Despite concerted efforts, high risk drinking remains a significant problem on college campuses. Further, the transition into college is an identified critical period in which risky drinking patterns are often established and serious negative consequences occur. Colleges commonly employ Normative Re-Education (NR), a promising intervention approach focused on correcting over-estimated peer drinking norms, to reduce alcohol risk in first-year students. However, the most cost-effective and scalable NR intervention strategy, web-based personalized normative feedback (PNF), has yielded only modest reductions in drinking. Several issues have been identified that may explain these relatively small effects. For example, students often question the credibility of the normative data, the content fails to capture students' attention, and heavy drinkers often react to feedback defensively. These issues are not surprising as, unlike social media and digital gaming applications that capture and sustain young adults' attention, web-based PNF formats lack the sophisticated digital graphics, social interactivity, and other dynamic features to which students have become accustomed. Further, colleges often make participation mandatory or offer incentives to enroll students in current interventions, likely a detriment to student motivation and thus intervention effectiveness. CampusGANDR (Gamified Alcohol Norm Discovery and Re-education) addresses these issues by delivering alcohol PNF within a fun, gamified smartphone app that tests first-year students' perceptions of college life and classmates' attitudes and behaviors on a weekly basis across the first semester of college. Integrating features from popular social media platforms and evidence-based digital game mechanics (e.g., co-presence, a wager-based system of points, and chance-based uncertainty), CampusGANDR also features enhanced PNF and includes several novel features informed by longstanding cognitive and social psychological theories.
Based on extensive pilot work, the current proposal seeks to: 1) evaluate the efficacy of CampusGANDR in a large-scale multi-site randomized controlled trial (RCT); 2) identify the optimal dosage of alcohol feedback to deliver within CampusGANDR for correcting norms and reducing alcohol use among students who differ in alcohol use (non-drinkers, light to moderate drinkers, and heavy drinkers); 3) examine person-level moderators of intervention efficacy; and 4) evaluate CampusGANDR engagement and the sustainability of play among students who use the app but aren't recruited into the evaluation study (RCT).
Incoming first-year students at colleges and universities in California (Loyola Marymount University site) and Texas (University of Houston site) consecutive cohorts of first-year students will be invited to download the CampusGANDR app to test their perceptions of campus life compete against their classmates. Then, among students already playing CampusGANDR, a balanced sub-sample of 1,800 non-drinking, light/moderate drinking, and heavy drinking students will be invited to take part in an evaluation study (RCT). Study participants will play CampusGANDR over the initial 12 weeks of the fall semester and complete 4 surveys assessing their alcohol use, social media use, health behaviors, mental health, and adjustment to college. Study participants will be discretely randomized to receive alcohol feedback 0%, 33%, or 67% of weekly CampusGANDR rounds through a backend manipulation of chance elements. Students not meeting study eligibility criteria and those not electing to take part in the evaluation study will still take part in CampusGANDR. The dosage of alcohol feedback among these non-RCT players receive will be determined at random and their app usage data will be employed to assess app engagement and sustainability of play in the absence of study incentives. This project aims to culminate in a highly engaging, scalable, cutting-edge native smartphone app (IOS, Android) able to dynamically tailor the dosage of alcohol feedback delivered based on students' alcohol experience at the point of matriculation.
To play CampusGANDR individuals must:
Additional RCT Inclusion Criteria
To take part in the evaluation study participants must:
Exclusion criteria for both:
Personalized Normative Feedback on non-alcohol/health related topics delivered in all weekly rounds (active control)
Behavioral: Gamified Personalized Normative Feedback
Personalized Normative Feedback on Alcohol Use delivered in 33% of weekly rounds
Behavioral: Gamified Personalized Normative Feedback
Personalized Normative Feedback on Alcohol Use delivered in 67% of weekly rounds
Behavioral: Gamified Personalized Normative Feedback
Each week, all players will answer 3 questions of interest about first-year students' attitudes and behaviors (e.g., drinking, partying, exercising, studying, dorm life, etc.) generated by the student players. They will also guess how the typical same-sex student at their University answered the same questions and wager points on how close to the correct answer (group norm) each of their guesses is. Further, they will rate (e.g., thumbs up/thumbs down) the reported behaviors of other players and, then, submit and vote on questions for subsequent rounds. At the end of each week, players will receive enhanced personalized normative feedback feedback on two of the three questions, and receive feedback on how other students rated the answer they reported (preferred-sex injunctive norms).
Also known as: GANDR
Change From Baseline Daily Drinking at 4 Months
The Daily Drinking Questionnaire assessess the number of drinks consumed per week in a typical week over the past three months.
Time frame: baseline, 4 months
Change From Baseline Daily Drinking at 9 Months
The Daily Drinking Questionnaire assesses the number of drinks consumed per week in a typical week over the past three months.
Time frame: baseline, 9 months
Change From Baseline Daily Drinking at 12 Months
Assesses number of drinks consumed during an average week over the past month
Time frame: baseline, 12 months
Change From Baseline Alcohol Consequences at 4 Months
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
Time frame: baseline, 4 months
Change From Baseline Alcohol Consequences at 9 Months
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
Time frame: baseline, 9 months
Change From Baseline Alcohol Consequences at 12 Months
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
Time frame: baseline, 12 months
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months
We used the Quantity/Frequency/Peak Alcohol measure to assess peak drinks. Participants reported the largest number of drinks they consumed on one occasion in the past 30 days.
Time frame: baseline, 4 months
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 9 Months
Assesses frequency and quantity of alcohol consumption over the past month
Time frame: baseline, 9 months
Change From Baseline Quantity/Frequency/Peak Alcohol Use at 12 Months
Assesses frequency and quantity of alcohol consumption over the past month
Time frame: baseline, 12 months
Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 4 Months
Assesses perceptions of weekly alcohol consumption among peers over the past month
Time frame: baseline, 4 months
Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 9 Months
Assesses perceptions of weekly alcohol consumption among peers over the past month
Time frame: baseline, 9 months
Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 12 Months
Assesses perceptions of weekly alcohol consumption among peers over the past month
Time frame: baseline, 12 months
Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 4 Months
Assesses perceptions of peers' frequency and quantity of drinking over the past month
Time frame: baseline, 4 months
Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 9 Months
Assesses perceptions of peers' frequency and quantity of drinking over the past month
Time frame: baseline, 9 months
Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 12 Months
Assesses perceptions of peers' frequency and quantity of drinking over the past month
Time frame: baseline, 12 months
Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 4 Months
Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors.
Time frame: baseline, 4 months
Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 9 Months
Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors.
Time frame: baseline, 9 months
Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 12 Months
Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors; group-level data are summarized using the Mean (Measure Type) and SD (Dispersion Type).
Time frame: baseline, 12 months
| Milestone | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Started | 388 | 374 | 381 |
| Wave 2 | 311 | 290 | 294 |
| Wave 3 | 301 | 291 | 291 |
| Wave 4 | 295 | 283 | 290 |
| Completed | 388 | 374 | 381 |
| Not completed | 0 | 0 | 0 |
The Daily Drinking Questionnaire assessess the number of drinks consumed per week in a typical week over the past three months.
| Drinks per week | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Daily Drinking at 4 Months | 2.11 ± 4.97 | 1.79 ± 5.84 | 2.18 ± 4.81 |
The Daily Drinking Questionnaire assesses the number of drinks consumed per week in a typical week over the past three months.
| Drinks per week | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Daily Drinking at 9 Months | 1.85 ± 4.15 | 1.67 ± 3.59 | 2.05 ± 4.75 |
Assesses number of drinks consumed during an average week over the past month
| Drinks per week | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Daily Drinking at 12 Months | 2.16 ± 4.74 | 2.31 ± 4.76 | 2.00 ± 3.72 |
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
| scores on a scale | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Alcohol Consequences at 4 Months | 2.06 ± 3.65 | 2.02 ± 4.10 | 1.85 ± 3.49 |
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
| scores on a scale | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Alcohol Consequences at 9 Months | 1.95 ± 3.44 | 2.24 ± 4.01 | 2.29 ± 4.10 |
Young Adult Alcohol Consequences Questionnaire (YAACQ; Read et al., 2006) was used to assess alcohol-related negative consequences in the past month. Participants indicate whether or not they experienced each of 48 alcohol-related negative consequences in the past month (0 = no, 1 = yes). Items are summed to yield a total score reflecting the number of alcohol-related problems experienced. Scores range from 0 to 48, where higher scores indicate a greater number of alcohol-related negative consequences (worse outcome).
| scores on a scale | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Alcohol Consequences at 12 Months | 2.32 ± 4.08 | 2.32 ± 3.72 | 2.17 ± 3.97 |
We used the Quantity/Frequency/Peak Alcohol measure to assess peak drinks. Participants reported the largest number of drinks they consumed on one occasion in the past 30 days.
| Peak number of drinks | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Quantity/Frequency/Peak Alcohol Use at 4 Months | 1.86 ± 3.27 | 1.53 ± 2.86 | 1.95 ± 3.41 |
Assesses frequency and quantity of alcohol consumption over the past month
| Peak number of drinks | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Quantity/Frequency/Peak Alcohol Use at 9 Months | 1.98 ± 3.52 | 1.94 ± 3.31 | 2.09 ± 3.67 |
Assesses frequency and quantity of alcohol consumption over the past month
| Peak number of drinks | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Quantity/Frequency/Peak Alcohol Use at 12 Months | 1.88 ± 3.00 | 2.10 ± 3.35 | 1.90 ± 3.01 |
Assesses perceptions of weekly alcohol consumption among peers over the past month
| Drinks per week (descriptive norm) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 4 Months | 7.00 ± 8.25 | 5.75 ± 6.87 | 5.76 ± 6.32 |
Assesses perceptions of weekly alcohol consumption among peers over the past month
| Drinks per week (descriptive norm) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 9 Months | 5.47 ± 7.27 | 5.45 ± 6.67 | 5.36 ± 6.84 |
Assesses perceptions of weekly alcohol consumption among peers over the past month
| Drinks per week (descriptive norm) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Descriptive Peer Drinking Norms- Drinking Norms Rating Form at 12 Months | 6.91 ± 9.06 | 6.08 ± 6.58 | 5.65 ± 6.37 |
Assesses perceptions of peers' frequency and quantity of drinking over the past month
| Peak number of drinks (descriptive norm) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 4 Months | 5.12 ± 3.60 | 4.49 ± 3.14 | 4.86 ± 4.14 |
Assesses perceptions of peers' frequency and quantity of drinking over the past month
| Peak number of drinks (descriptive norm) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 9 Months | 4.86 ± 3.59 | 5.24 ± 3.63 | 4.52 ± 3.42 |
Assesses perceptions of peers' frequency and quantity of drinking over the past month
| Peak number of drinks (descriptive norm) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Descriptive Peer Drinking Norms- Modified Quantity, Frequency, Peak Index at 12 Months | 5.41 ± 3.52 | 4.92 ± 3.70 | 4.98 ± 3.69 |
Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors.
| scores on a scale | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 4 Months | 4.18 ± 1.09 | 4.16 ± 1.01 | 4.01 ± 1.13 |
Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors.
| scores on a scale | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 9 Months | 4.25 ± 1.03 | 4.27 ± 0.93 | 4.07 ± 1.05 |
Perceived Injunctive Norms scale was used to assess participants' estimates of how acceptable other same-sex students at their university find each of 15 drinking behaviors (e.g., drinking to get drunk, drinking alone, driving after drinking). Participants rate the acceptability of each behavior on a scale from 1 (completely unacceptable) to 7 (completely acceptable). Ratings are averaged across all 15 items to yield a total score ranging from 1 to 7, where higher scores indicate greater perceived peer approval of drinking behaviors; group-level data are summarized using the Mean (Measure Type) and SD (Dispersion Type).
| scores on a scale | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF |
|---|---|---|---|
| Change From Baseline Injunctive Peer Drinking Norms (Adapted From Baer, 1994) at 12 Months | 4.31 ± 0.98 | 4.28 ± 0.94 | 4.12 ± 1.01 |
Collected over From enrollment until end of follow-up (13 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control PNF | 0/388 (0%) | 0/388 (0%) | 0/388 (0%) |
| Light Dose of Alcohol PNF | 0/374 (0%) | 0/374 (0%) | 0/374 (0%) |
| Heavy Dose of Alcohol PNF | 0/381 (0%) | 0/381 (0%) | 0/381 (0%) |
1143 Participants were assigned to condition.
| Age, Continuous(Years) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF | Total |
|---|---|---|---|---|
| Mean | 18.40 ± .62 | 18.41 ± .64 | 18.37 ± .59 | 18.39 ± .62 |
| Sex: Female, Male(Participants) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF | Total |
|---|---|---|---|---|
| Female | 248 | 243 | 247 | 738 |
| Male | 140 | 131 | 134 | 405 |
| Race (NIH/OMB)(Participants) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 8 | 6 | 7 | 21 |
| Asian | 105 | 109 | 104 | 318 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 47 | 44 | 46 | 137 |
| White | 181 | 165 | 168 | 514 |
| More than one race | 44 | 45 | 54 | 143 |
| Unknown or Not Reported | 3 | 4 | 2 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF | Total |
|---|---|---|---|---|
| Hispanic or Latino | 130 | 110 | 117 | 357 |
| Not Hispanic or Latino | 258 | 264 | 264 | 786 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Drinks per week(Number of alcoholic drinks per week) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF | Total |
|---|---|---|---|---|
| Mean | 1.97 ± 5.99 | 1.86 ± 4.45 | 1.64 ± 3.87 | 1.82 ± 4.86 |
| Peak drinks(number of alcoholic drinks) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF | Total |
|---|---|---|---|---|
| Mean | 1.50 ± 3.00 | 1.53 ± 3.01 | 1.43 ± 2.65 | 1.49 ± 2.89 |
| Alcohol Problems(scores on a scale) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF | Total |
|---|---|---|---|---|
| Mean | 2.09 ± 3.60 | 1.88 ± 3.55 | 1.58 ± 2.84 | 1.85 ± 3.35 |
| Perceived descriptive norm for peak drinks(drinks/occasion) | Control PNF | Light Dose of Alcohol PNF | Heavy Dose of Alcohol PNF | Total |
|---|---|---|---|---|
| Mean | 5.55 ± 4.85 | 5.46 ± 4.87 | 5.60 ± 5.13 | 5.54 ± 4.95 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Study results will be reported in aggregate, so that individual participants will not be identifiable in any research reports or presentations of the proposed study. A de-identified dataset will be made available to researchers 1 year after the initial publication of results. This dataset will include participant demographics and outcome measures assessed at baseline and the follow-up surveys. A data dictionary will be provided.
Supporting information: Study protocol, Icf
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Loyola Marymount University