Alcohol Use, Unspecified, Insomnia, Marijuana Use
Conditions
Keywords
Insomnia, Alcohol Use, Marijuana Use, Young Adults
Brief summary
This study is designed to develop an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.
Detailed description
This study is designed to develop an integrated intervention to reduce alcohol and MJ use and consequences and improve sleep among young adults (YA) with comorbid heavy episodic drinking (HED), MJ use, and sleep impairment. HED in YA is an important public health problem, with consequences including accidental injury and death, academic or work problems, unsafe and unwanted sex, and development of alcohol use disorders. Many YA with HED also use MJ, often simultaneously, and experience increased harm as a result. Sleep impairment is common and problematic among YA, identified as the 3rd leading barrier to academic success for students and an important risk factor for mental health problems and suicide in YA. Alcohol use has been linked to impaired sleep in adolescent, YA, college, and older adult populations, with bidirectional causal links between alcohol use and impaired sleep, including negative physiological effects of alcohol on the sleep cycle (e.g., suppression of REM sleep), use of alcohol to promote sleep onset which can both increase alcohol use and resultant sleep impairment, and poor sleep hygiene including delayed and variable sleep-wake timing associated with cyclical patterns of alcohol use during evening and/or weekend social events. Comorbidity of HED and sleep impairment is associated with increased consequences of alcohol use, and exacerbates risk of accidents (including automobile accidents), impaired decision-making, and work and academic difficulties. Similar bidirectional relations exist with MJ use and sleep. Despite risks and consequences, alcohol and MJ prevention programs rarely target sleep directly, and the majority of YA interventions for sleep either focus on sleep hygiene broadly in the absence of specific strategies shown to improve sleep or reduce alcohol or MJ use, or have been relatively intensive interventions with insufficient sample size to truly evaluate impacts on sleep or related comorbid alcohol or MJ use. The current study addresses these gaps through developing and evaluating feasibility and preliminary efficacy of a brief, integrated intervention combining efficacious brief motivational feedback and skills for reducing HED and MJ use and consequences (BASICS) with Brief Behavioral Therapy for Insomnia (SLEEP) shown to improve sleep in other populations. Feasibility and efficacy will be evaluated over a 3-month period, using surveys and daily diaries to assess alcohol, MJ, and sleep at post-intervention and 3- months. Specific aims are: 1) Assess feasibility, acceptability, and preliminary efficacy BASICS + SLEEP in reducing alcohol use and consequences, improving sleep, and weakening daily and lagged (next day) relationships between alcohol and MJ use and sleep impairment; and 2) Use diary data to explore daily and lagged relationships between alcohol use, MJ, sleep impairment, and unique YA contextual factor to further inform prevention of comorbid alcohol use, MJ, and sleep impairment.
Interventions
Brief Behavioral Therapy for Insomnia (BBTI) focuses primarily on stimulus control and sleep restriction as well as sleep hygiene recommendations delivered over 2 in-person sessions and 2 brief telephone boosters and is designed to be implemented by nonspecialists in primary care or other non-clinical settings. The intervention is manualized, and clients utilize sleep diaries and workbook assignments to consolidate recommendations.
Brief Alcohol Screening and Intervention for College Students (BASICS) is a manualized brief intervention targeting alcohol use and consequences among high risk drinkers and includes both personalized feedback regarding drinking norms, consequences, and motives for drinking, as well as protective behavioral skills for reducing heavy episodic drinking and related consequences. BASICS is delivered in a motivational interviewing (MI) style (Miller & Rollnick, 2002) to enhance intrinsic motivation to change drinking and implement protective behavioral strategies. BASICS has been adapted to target marijuana use and has been adapted for use with a variety of populations.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-24, score on the ISI of 10 or higher, reporting at least one heavy drinking episode in the past two weeks, use of marijuana at least once in the past month
Exclusion criteria
* Not meeting the Inclusion Criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rutgers Alcohol Problems Index | Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline) | The Rutgers Alcohol Problem Index (23 items) assessed negative consequences related to drinking. Two items were added to assess driving after drinking 2 or more drinks and 4 or more drinks. Response options range from 0=Never to 4=More than 10 times. Responses were summed to create a total score of problems experienced in the previous 3 months. Possible scores ranged from 0 to 100. |
| Quantity/Frequency/Peak Alcohol Use Index (QFP) Frequency Item | Baseline, 3 Month Follow-up (3 months post-Baseline) | The Quantity Frequency Peak Alcohol Use Index was used to assess the frequency of drinking over a typical week over the previous month. Response options range from 0=I do not drink at all to 7=Every day. |
| Daily Drinking Questionnaire (DDQ) | Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline) | The Daily Drinking Questionnaire assesses the typical number of drinks consumed on each day of a typical week over the previous month. Responses were summed to create a total score of overall number of standard drinks consumed over a typical week. |
| Insomnia Severity Index (ISI) | Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline) | The Insomnia Severity Index is a 7-item measure that assesses the severity of both nighttime and daytime aspects of insomnia. Response options utilized a 5-point Likert scale ranging from 0-4 where 0 reflected low symptom endorsement and 4 reflected high symptom endorsement. Responses across the 7 items are summed to create a Total Score. Total Scores range from 0 to 28. Total scores of 0-7=No clinically significant insomnia, 8-14=subthreshold insomnia, 15-21=clinical insomnia (moderate severity), and 22-28=clinical insomnia (severe). |
| Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI) | Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline) | The Patient-Reported Outcomes Information System Short Form v1.0 Sleep Related Impairment 8a (8-items) assesses self-reported perceptions of impairment due to sleep problems. Response options range from 1=Not at all to 5=Very much and are summed to create a raw score (range 8-40). Raw scores are transformed to T-scores with a population mean of 50 and a standard deviation (SD) of 10, where higher scores indicate greater impairment due to sleep problems. For example, a T-score of 60 is one SD worse than average, whereas a T-score of 40 is one SD better than average. |
| Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item | Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline) | The Quantity Frequency Peak Alcohol Use Index was used to assess the peak number of standard drinks consumed on their heaviest drinking occasion over the previous month. |
| Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item | Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline) | The Quantity Frequency Peak Alcohol Use Index was used to assess typical drinking quantity using the number of drinks consumed during a typical drinking occasion over the previous month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marijuana-Related Consequences | Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline) | Marijuana Consequences were assessed with a 29-item measure assessing consequences related to marijuana use. Response options range from 0=Never to 4=More than 10 times. Scores are summed to create a total score of problems experienced in the previous 3 months. Possible scores ranged from 0 to 116. |
| Daily Marijuana Questionnaire | Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline) | The Daily Marijuana Questionnaire was used to assess hours high from cannabis use on each day over a typical week in the past month. Items were summed to create a total score of overall number of hours spent high during a typical week. |
Countries
United States
Participant flow
Recruitment details
Participants (N=150, aged 18-24) were recruited in spring 2021 - spring 2022 via online advertising (e.g., Instagram/Facebook, Reddit, TikTok, Craigslist) and from young adults responding to advertising or invitations for other studies in the investigators' lab for which they did not meet criteria, who met initial screening criteria for the study and agreed to future contact. Participants recruited from either source completed additional screening and identity verification prior to enrollment.
Participants by arm
| Arm | Count |
|---|---|
| BASICS + SLEEP The BASICS + SLEEP intervention integrated BASICS feedback and Motivational Interviewing (MI) for alcohol and marijuana use as described in the BASICS arm with Brief Behavioral Therapy for Insomnia (BBTI). The BASICS + SLEEP intervention was implemented in 2 telehealth sessions of 45-75 minutes and 2 telehealth booster sessions (20-30 mins). Sessions provided rationale for insomnia and importance of behavioral strategies to regulate sleep; introduction of sleep hygiene; discussion of factors (including alcohol and cannabis use) that impede duration and quality of sleep; introduction of sleep restriction and stimulus control strategies and negotiation of an initial sleep restriction schedule and alcohol/cannabis goals; and follow-up evaluation of success and continued refinement to achieve sleep efficiency goals. Booster contacts serve as opportunities to adjust the sleep restriction schedule, problem-solve challenges, and further build motivation. The intervention included personalized feedback depicting both alcohol and cannabis use and perceived norms as well as insomnia symptoms. Feedback also addressed personal maintaining factors for insomnia, sleep hygiene factors, and protective behavioral strategies for both alcohol and cannabis use. | 49 |
| BASICS The BASICS condition was conducted via telehealth for 2 sessions of 45-75 minutes and 2 telehealth booster sessions (20-30 minutes). Brief Alcohol Screening and Intervention for College Students (BASICS) is a manualized brief intervention targeting alcohol use and consequences among high-risk drinkers and includes both personalized feedback regarding drinking norms, consequences, and motives for drinking, as well as protective behavioral skills for reducing heavy episodic drinking and related consequences. BASICS is delivered in a motivational interviewing (MI) style (Miller & Rollnick, 2002) to enhance intrinsic motivation to change drinking and implement protective behavioral strategies. BASICS has been adapted to target marijuana use and has been adapted for use with a variety of populations. Both alcohol and cannabis content were integrated in this condition but without specific content to address insomnia symptoms. | 51 |
| Assessment Only Control Participants in Assessment Only Control (AOC) condition completed all assessments (including survey, daily, actigraphy) at the same time as participants in the 2 active interventions. AOC also attended an in-person meeting to verify identity, provide rationale for daily monitoring, control for time/attention, and participants in all conditions including AOC received referrals for community services to address alcohol and MJ use, sleep, and other mental health concerns. No participants were deprived of services. AOC condition was offered BASICS + SLEEP after the 3-month follow-up. | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 7 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 7 | 3 |
Baseline characteristics
| Characteristic | BASICS + SLEEP | BASICS | Assessment Only Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 51 Participants | 50 Participants | 150 Participants |
| Age, Continuous | 21.37 years STANDARD_DEVIATION 1.68 | 21.16 years STANDARD_DEVIATION 1.78 | 20.74 years STANDARD_DEVIATION 1.6 | 21.09 years STANDARD_DEVIATION 1.7 |
| Daily Drinking Questionnaire (DDQ) | 10.18 Standard drinks per week STANDARD_DEVIATION 7.41 | 11.29 Standard drinks per week STANDARD_DEVIATION 8.41 | 13.5 Standard drinks per week STANDARD_DEVIATION 14.25 | 11.67 Standard drinks per week STANDARD_DEVIATION 10.49 |
| Daily Marijuana Questionnaire | 16.06 Hours high per week STANDARD_DEVIATION 17.95 | 16.47 Hours high per week STANDARD_DEVIATION 16.74 | 15.26 Hours high per week STANDARD_DEVIATION 19.22 | 15.93 Hours high per week STANDARD_DEVIATION 17.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 6 Participants | 5 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 45 Participants | 45 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Insomnia Severity Index (ISI) | 15.04 Score on a scale STANDARD_DEVIATION 3.78 | 15.22 Score on a scale STANDARD_DEVIATION 3.55 | 15.20 Score on a scale STANDARD_DEVIATION 3.53 | 15.15 Score on a scale STANDARD_DEVIATION 3.59 |
| Marijuana-Related Consequences | 31.57 Score on a scale STANDARD_DEVIATION 18.88 | 32.78 Score on a scale STANDARD_DEVIATION 20.71 | 30.80 Score on a scale STANDARD_DEVIATION 15.75 | 31.73 Score on a scale STANDARD_DEVIATION 18.47 |
| Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a | 63.72 T-Score STANDARD_DEVIATION 5.66 | 63.70 T-Score STANDARD_DEVIATION 5.3 | 63.76 T-Score STANDARD_DEVIATION 6.76 | 63.73 T-Score STANDARD_DEVIATION 5.89 |
| Quantity/Frequency/Peak Alcohol Use Index (QFP) frequency item | 14.16 Days per week STANDARD_DEVIATION 5.94 | 13.62 Days per week STANDARD_DEVIATION 5.88 | 13.73 Days per week STANDARD_DEVIATION 7.12 | 13.84 Days per week STANDARD_DEVIATION 6.27 |
| Quantity/Frequency/Peak Alcohol Use Index (QFP) peak item | 7.80 Peak number of standard drinks STANDARD_DEVIATION 3.03 | 7.69 Peak number of standard drinks STANDARD_DEVIATION 2.89 | 8.18 Peak number of standard drinks STANDARD_DEVIATION 4.21 | 7.89 Peak number of standard drinks STANDARD_DEVIATION 3.41 |
| Quantity/Frequency/Peak Alcohol Use Index (QFP) quantity item | 3.53 Standard drinks per occasion STANDARD_DEVIATION 1.46 | 4.12 Standard drinks per occasion STANDARD_DEVIATION 2.96 | 4.16 Standard drinks per occasion STANDARD_DEVIATION 2.71 | 3.94 Standard drinks per occasion STANDARD_DEVIATION 2.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 8 Participants | 7 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 5 Participants | 9 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 31 Participants | 34 Participants | 29 Participants | 94 Participants |
| Region of Enrollment United States | 49 participants | 51 participants | 50 participants | 150 participants |
| Rutgers Alcohol Problems Index | 10.82 Score on a scale STANDARD_DEVIATION 9.09 | 12.33 Score on a scale STANDARD_DEVIATION 14.94 | 8.88 Score on a scale STANDARD_DEVIATION 11.45 | 10.69 Score on a scale STANDARD_DEVIATION 12.11 |
| Sex: Female, Male Female | 13 Participants | 18 Participants | 14 Participants | 45 Participants |
| Sex: Female, Male Male | 36 Participants | 33 Participants | 36 Participants | 105 Participants |
| Sex/Gender, Customized Men | 12 Participants | 19 Participants | 13 Participants | 44 Participants |
| Sex/Gender, Customized Non-binary/Gender Diverse | 6 Participants | 4 Participants | 6 Participants | 16 Participants |
| Sex/Gender, Customized Women | 31 Participants | 28 Participants | 31 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 0 / 49 | 0 / 51 | 0 / 50 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 | 0 / 50 |
Outcome results
Primary
Daily Drinking Questionnaire (DDQ)
The Daily Drinking Questionnaire assesses the typical number of drinks consumed on each day of a typical week over the previous month. Responses were summed to create a total score of overall number of standard drinks consumed over a typical week.
Time frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASICS + SLEEP | Daily Drinking Questionnaire (DDQ) | Post Assessment | 6.43 Standard drinks per week | Standard Deviation 6.77 |
| BASICS + SLEEP | Daily Drinking Questionnaire (DDQ) | 3 Month Follow-up | 6.09 Standard drinks per week | Standard Deviation 6.12 |
| BASICS | Daily Drinking Questionnaire (DDQ) | Post Assessment | 6.50 Standard drinks per week | Standard Deviation 6.67 |
| BASICS | Daily Drinking Questionnaire (DDQ) | 3 Month Follow-up | 4.48 Standard drinks per week | Standard Deviation 4.24 |
| Assessment Only Control | Daily Drinking Questionnaire (DDQ) | Post Assessment | 11.05 Standard drinks per week | Standard Deviation 9.81 |
| Assessment Only Control | Daily Drinking Questionnaire (DDQ) | 3 Month Follow-up | 10.63 Standard drinks per week | Standard Deviation 9.86 |
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.00995% CI: [0.535, 0.914]Generalized linear mixed model
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.p-value: 0.00595% CI: [0.512, 0.888]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.01395% CI: [0.526, 0.928]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.p-value: <0.00195% CI: [0.385, 0.715]Generalized linear mixed model
Primary
Insomnia Severity Index (ISI)
The Insomnia Severity Index is a 7-item measure that assesses the severity of both nighttime and daytime aspects of insomnia. Response options utilized a 5-point Likert scale ranging from 0-4 where 0 reflected low symptom endorsement and 4 reflected high symptom endorsement. Responses across the 7 items are summed to create a Total Score. Total Scores range from 0 to 28. Total scores of 0-7=No clinically significant insomnia, 8-14=subthreshold insomnia, 15-21=clinical insomnia (moderate severity), and 22-28=clinical insomnia (severe).
Time frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASICS + SLEEP | Insomnia Severity Index (ISI) | Post Assessment | 8.48 Score on a scale | Standard Deviation 4.73 |
| BASICS + SLEEP | Insomnia Severity Index (ISI) | 3 Month Follow-up | 7.14 Score on a scale | Standard Deviation 4.61 |
| BASICS | Insomnia Severity Index (ISI) | Post Assessment | 9.69 Score on a scale | Standard Deviation 3.24 |
| BASICS | Insomnia Severity Index (ISI) | 3 Month Follow-up | 8.97 Score on a scale | Standard Deviation 5.55 |
| Assessment Only Control | Insomnia Severity Index (ISI) | Post Assessment | 11.31 Score on a scale | Standard Deviation 3.38 |
| Assessment Only Control | Insomnia Severity Index (ISI) | 3 Month Follow-up | 9.71 Score on a scale | Standard Deviation 4 |
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.00495% CI: [-0.65, -0.127]Regression, Linear
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.p-value: 0.11895% CI: [-0.482, 0.054]Regression, Linear
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.00395% CI: [-0.674, -0.142]Regression, Linear
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.p-value: 0.2495% CI: [-0.428, 0.107]Regression, Linear
Primary
Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)
The Patient-Reported Outcomes Information System Short Form v1.0 Sleep Related Impairment 8a (8-items) assesses self-reported perceptions of impairment due to sleep problems. Response options range from 1=Not at all to 5=Very much and are summed to create a raw score (range 8-40). Raw scores are transformed to T-scores with a population mean of 50 and a standard deviation (SD) of 10, where higher scores indicate greater impairment due to sleep problems. For example, a T-score of 60 is one SD worse than average, whereas a T-score of 40 is one SD better than average.
Time frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASICS + SLEEP | Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI) | Post Assessment | 54.06 T-Score | Standard Deviation 7.85 |
| BASICS + SLEEP | Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI) | 3 Month Follow-up | 52.66 T-Score | Standard Deviation 7.93 |
| BASICS | Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI) | Post Assessment | 57.31 T-Score | Standard Deviation 6.97 |
| BASICS | Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI) | 3 Month Follow-up | 56.57 T-Score | Standard Deviation 7.27 |
| Assessment Only Control | Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI) | Post Assessment | 58.72 T-Score | Standard Deviation 6.38 |
| Assessment Only Control | Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI) | 3 Month Follow-up | 57.11 T-Score | Standard Deviation 7.71 |
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.00395% CI: [-8.1, -1.65]Regression, Linear
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)p-value: 0.30895% CI: [-4.98, 1.57]Regression, Linear
Comparison: Changes from Baseline to 3 Month for BASICS+SLEEP vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)p-value: 0.00795% CI: [-7.8, -1.25]Regression, Linear
Comparison: Changes from Baseline to 3 Month for BASICS vs. AOC reported in this section. Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/ )p-value: 0.62195% CI: [-4.12, 2.46]Regression, Linear
Primary
Quantity/Frequency/Peak Alcohol Use Index (QFP) Frequency Item
The Quantity Frequency Peak Alcohol Use Index was used to assess the frequency of drinking over a typical week over the previous month. Response options range from 0=I do not drink at all to 7=Every day.
Time frame: Baseline, 3 Month Follow-up (3 months post-Baseline)
Population: Analyses are using 3 Month Follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BASICS + SLEEP | Quantity/Frequency/Peak Alcohol Use Index (QFP) Frequency Item | 8.49 Days per week | Standard Deviation 6.75 |
| BASICS | Quantity/Frequency/Peak Alcohol Use Index (QFP) Frequency Item | 6.79 Days per week | Standard Deviation 4.97 |
| Assessment Only Control | Quantity/Frequency/Peak Alcohol Use Index (QFP) Frequency Item | 9.66 Days per week | Standard Deviation 6.19 |
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.03295% CI: [0.54, 0.973]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.p-value: <0.00195% CI: [0.432, 0.8]Generalized linear mixed model
Primary
Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item
The Quantity Frequency Peak Alcohol Use Index was used to assess the peak number of standard drinks consumed on their heaviest drinking occasion over the previous month.
Time frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASICS + SLEEP | Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item | Post Assessment | 6.45 Peak number of standard drinks | Standard Deviation 3.15 |
| BASICS + SLEEP | Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item | 3 Month Follow-up | 5.06 Peak number of standard drinks | Standard Deviation 2.94 |
| BASICS | Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item | Post Assessment | 5.92 Peak number of standard drinks | Standard Deviation 2.86 |
| BASICS | Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item | 3 Month Follow-up | 4.44 Peak number of standard drinks | Standard Deviation 2.71 |
| Assessment Only Control | Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item | Post Assessment | 8.18 Peak number of standard drinks | Standard Deviation 4.77 |
| Assessment Only Control | Quantity/Frequency/Peak Alcohol Use Index (QFP) Peak Item | 3 Month Follow-up | 7.24 Peak number of standard drinks | Standard Deviation 5.08 |
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.05495% CI: [0.641, 1.003]Mixed Models Analysis
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.p-value: 0.01595% CI: [0.6, 0.946]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.01395% CI: [0.578, 0.937]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.p-value: 0.00195% CI: [0.513, 0.844]Generalized linear mixed model
Primary
Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item
The Quantity Frequency Peak Alcohol Use Index was used to assess typical drinking quantity using the number of drinks consumed during a typical drinking occasion over the previous month.
Time frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASICS + SLEEP | Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item | Post Assessment | 2.93 Drinks per occasion | Standard Deviation 1.75 |
| BASICS + SLEEP | Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item | 3 Month Follow-up | 2.63 Drinks per occasion | Standard Deviation 1.48 |
| BASICS | Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item | Post Assessment | 2.58 Drinks per occasion | Standard Deviation 1.61 |
| BASICS | Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item | 3 Month Follow-up | 2.41 Drinks per occasion | Standard Deviation 1.79 |
| Assessment Only Control | Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item | Post Assessment | 3.36 Drinks per occasion | Standard Deviation 2.05 |
| Assessment Only Control | Quantity/Frequency/Peak Alcohol Use Index (QFP) Quantity Item | 3 Month Follow-up | 3.61 Drinks per occasion | Standard Deviation 2.61 |
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.9695% CI: [0.716, 1.374]Generalized linear mixed model
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.p-value: 0.15295% CI: [0.506, 1.094]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.48295% CI: [0.634, 1.24]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.p-value: 0.0295% CI: [0.634, 1.24]Generalized linear mixed model
Primary
Rutgers Alcohol Problems Index
The Rutgers Alcohol Problem Index (23 items) assessed negative consequences related to drinking. Two items were added to assess driving after drinking 2 or more drinks and 4 or more drinks. Response options range from 0=Never to 4=More than 10 times. Responses were summed to create a total score of problems experienced in the previous 3 months. Possible scores ranged from 0 to 100.
Time frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASICS + SLEEP | Rutgers Alcohol Problems Index | Post Assessment | 6.85 Score on a scale | Standard Deviation 9.41 |
| BASICS + SLEEP | Rutgers Alcohol Problems Index | 3 Month Follow-up | 5.57 Score on a scale | Standard Deviation 7.05 |
| BASICS | Rutgers Alcohol Problems Index | Post Assessment | 5.25 Score on a scale | Standard Deviation 6.71 |
| BASICS | Rutgers Alcohol Problems Index | 3 Month Follow-up | 5.27 Score on a scale | Standard Deviation 9.1 |
| Assessment Only Control | Rutgers Alcohol Problems Index | Post Assessment | 7.64 Score on a scale | Standard Deviation 6.1 |
| Assessment Only Control | Rutgers Alcohol Problems Index | 3 Month Follow-up | 6.85 Score on a scale | Standard Deviation 6.52 |
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.0195% CI: [0.404, 0.885]Generalized linear mixed model
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.p-value: 0.00195% CI: [0.331, 0.76]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.00295% CI: [0.337, 0.79]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.p-value: 0.00295% CI: [0.33, 0.774]Generalized linear mixed model
Secondary
Daily Marijuana Questionnaire
The Daily Marijuana Questionnaire was used to assess hours high from cannabis use on each day over a typical week in the past month. Items were summed to create a total score of overall number of hours spent high during a typical week.
Time frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASICS + SLEEP | Daily Marijuana Questionnaire | Post Assessment | 7.95 Hours high per week | Standard Deviation 9.56 |
| BASICS + SLEEP | Daily Marijuana Questionnaire | 3 Month Follow-up | 9.18 Hours high per week | Standard Deviation 11.89 |
| BASICS | Daily Marijuana Questionnaire | Post Assessment | 8.34 Hours high per week | Standard Deviation 8.8 |
| BASICS | Daily Marijuana Questionnaire | 3 Month Follow-up | 8.26 Hours high per week | Standard Deviation 11.99 |
| Assessment Only Control | Daily Marijuana Questionnaire | Post Assessment | 11.21 Hours high per week | Standard Deviation 19.24 |
| Assessment Only Control | Daily Marijuana Questionnaire | 3 Month Follow-up | 11.6 Hours high per week | Standard Deviation 18.75 |
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.00395% CI: [0.462, 0.853]Generalized linear mixed model
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.p-value: 0.07395% CI: [0.538, 1.028]Generalized linear mixed model
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.0995% CI: [0.559, 1.043]Generalized linear mixed model
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.p-value: 0.01395% CI: [0.469, 0.916]Generalized linear mixed model
Secondary
Marijuana-Related Consequences
Marijuana Consequences were assessed with a 29-item measure assessing consequences related to marijuana use. Response options range from 0=Never to 4=More than 10 times. Scores are summed to create a total score of problems experienced in the previous 3 months. Possible scores ranged from 0 to 116.
Time frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline)
Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BASICS + SLEEP | Marijuana-Related Consequences | Post Assessment | 16.10 Score on a scale | Standard Deviation 15.86 |
| BASICS + SLEEP | Marijuana-Related Consequences | 3 Month Follow-up | 19.71 Score on a scale | Standard Deviation 15.02 |
| BASICS | Marijuana-Related Consequences | Post Assessment | 14.97 Score on a scale | Standard Deviation 14.91 |
| BASICS | Marijuana-Related Consequences | 3 Month Follow-up | 18.24 Score on a scale | Standard Deviation 17.19 |
| Assessment Only Control | Marijuana-Related Consequences | Post Assessment | 18.59 Score on a scale | Standard Deviation 13.78 |
| Assessment Only Control | Marijuana-Related Consequences | 3 Month Follow-up | 23.17 Score on a scale | Standard Deviation 12.69 |
Comparison: Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.08795% CI: [0.546, 1.041]Generalized linear mixed model
Comparison: Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.p-value: 0.07895% CI: [0.528, 1.034]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.p-value: 0.09995% CI: [0.569, 1.05]Generalized linear mixed model
Comparison: Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.p-value: 0.03195% CI: [0.512, 0.969]Generalized linear mixed model