Alcohol Use, Unspecified
Conditions
Brief summary
Successful treatment of alcohol associated liver disease (AALD) depends primarily on abstinence from alcohol. The investigators propose a randomized clinical trial of alcohol biosensor monitoring for patients with alcohol associated liver disease to determine if monitoring with feedback on alcohol use patterns reduces alcohol consumption and improves outcomes.
Detailed description
The investigators propose a 3 month randomized controlled trial (RCT) pilot of alcohol biosensor monitoring (ABM)(WrisTAS) for patients with Alcohol Associated Liver Disease (AALD) who intend to stop drinking. All participants will wear the ABM device but participants will be randomized to receive either personalized feedback on the data recorded on the device (n=30) or enhanced usual care without feedback on device data (n=30). The investigators will determine whether ABM plus feedback improves outcomes for AALD patients compared to enhanced usual care and hypothesize ABM feedback will reduce alcohol consumption, improve motivation and self-efficacy for abstinence and improve engagement in treatment. The investigators will also conduct research including qualitative data collected from participants who will provide opinions on ABM feasibility, acceptability, and usability. Qualitative methods are especially useful for understanding the perceived needs, barriers, and preferences for monitoring alcohol use and are especially required for future translation of this technology into clinical practice.
Interventions
Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources
Sponsors
Study design
Intervention model description
RCT feedback vs. enhanced usual care
Eligibility
Inclusion criteria
* Patients with AALD followed at our liver disease clinic, * 18 years or older, * willing to accept randomization, * and agree to wear device for 3 months, * SOCRATES problem recognition subscale score \>26 (scores \<26 indicate very low recognition of an alcohol problem).
Exclusion criteria
* Non-English speaking, * Montreal Cognitive Assessment (MOCA) scores \<21 (moderate cognitive impairment) or neurologic diseases (e.g. Parkinson's), * patients with unresponsive acute alcoholic hepatitis, multi-organ failure, fulminant hepatic failure, * cancer/terminal illness; * those unable to wear a wrist monitor (e.g., edema); * lacking a residence, or unable to identify a contact person (if lost to follow-up).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Days Drinking Per Interval of Device Wear | 3 months | Percent of days drinking per interval of device wear: We analyzed the data by number of drinking episodes per individual per days of device wear and present the mean percent days drinking per assessment interval |
| Alcohol Use | continuous for up to 3 months | Average number of drinks per drinking episode per interval (month) of device wear. We analyzed the number of drinks per drinking episode and present the group average per month interval of assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved Readiness for Alcohol Abstinence and Initiation of Change | Scores determined at initiation, 6 weeks and 3 months of participation | Stages of Change Readiness & Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness for change assessing three areas; ambivalence, recognition, and taking steps with change scores assessing the impact of an intervention on these areas. Three subscale scores are produced with total scores ranging 19-95 and higher score indicating greater readiness: * 7 items for recognition of an alcohol problem (scores range from low of 7 to highest of 35) * 4 items for ambivalence (range from low of 4 to highest of 20) * 8 items for taking steps to make a positive change in drinking (range from low of 8 to highest of 40) |
| Self Efficacy to Remain Abstinent | Scores determined at initiation, 6 weeks and 3 months of participation | Alcohol Abstinence Self-efficacy (AASE) evaluates confidence in ability to abstain from drinking in situations that represent typical drinking cues. Four subscales with 5 specific situations each are rated on confidence not to drink in each situations on a 5-point Likert scale from 1=not at all confident to 5=extremely confident. Total scores range from 20-100 with higher scores reflecting greater self confidence not to drink. * negative affect situations (range from low confidence of 5 to highest confidence of 25) * social/positive situations (range from low confidence of 5 to highest confidence of 25) * physical and other concerns situations (range from low confidence of 5 to highest confidence of 25) * cravings and urges situations (range from low confidence of 5 to highest confidence of 25) |
| Medical Outcomes | Counts determined at initiation, 6 weeks and 3 months of participation | AALD related hospitalizations and ER visits - total count of participants in each arm who experienced these outcomes |
| Qualitative Interviews | measured at three months (completion of the participants use of ABM) | Qualitative interviews of participants will use a semi-structured script of open-ended stem questions with prompts. The qualitative assessment will cover such topics as patients' perceived need/psychologic barriers (e.g., beliefs in value of ABM in their clinical care and for their relationship with clinicians) and experience with ABM (e.g., wearability, satisfaction, and barriers to monitoring). Transcribed interviews will be thematically coded. The constant comparison method will be used, and subsequent interviews may be modified/informed by findings from previous interviews to explore emerging themes as the analysis proceeds. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Feedback Participant will receive a brief feedback on data downloaded from the ABM and information about treatment resources
Feedback: Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources | 14 |
| Enhanced Usual Care Participant will receive information about remaining abstinent and about treatment resources
Enhanced Usual Care: Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Death | 2 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | Feedback |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 10 | 45 years STANDARD_DEVIATION 10 | 43 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 26 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 25 Participants | 14 Participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 11 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 14 | 2 / 13 |
| other Total, other adverse events | 7 / 14 | 7 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Alcohol Use
Average number of drinks per drinking episode per interval (month) of device wear. We analyzed the number of drinks per drinking episode and present the group average per month interval of assessment.
Time frame: continuous for up to 3 months
Population: We analyzed data for all 27 participants. Only 6 participants drank alcohol and their data is shown below. The remaining 21 participants had no alcohol use data to present.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Alcohol Use | Average drinks per drinking episode for first interval (month) of device wear | 7.4 drinks per episode | Standard Deviation 3.7 |
| Enhanced Usual Care | Alcohol Use | Average drinks per drinking episode for second interval (one month) of device wear | 5.3 drinks per episode | Standard Deviation 3.9 |
| Enhanced Usual Care | Alcohol Use | Average drinks per drinking episode for third interval (one month) of device wear | 4.4 drinks per episode | Standard Deviation 3.5 |
Percent of Days Drinking Per Interval of Device Wear
Percent of days drinking per interval of device wear: We analyzed the data by number of drinking episodes per individual per days of device wear and present the mean percent days drinking per assessment interval
Time frame: 3 months
Population: We analyzed all 27 participants but only 6 participants were found to be drinking. Thus only participants who drank (n=6) were analyzed for drinking outcomes. The numbers at follow up assessments are different than initially enrolled due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care | Percent of Days Drinking Per Interval of Device Wear | % Days of drinking per first interval of device wear | 0.48 percentage of days drinking | Standard Deviation 0.48 |
| Enhanced Usual Care | Percent of Days Drinking Per Interval of Device Wear | % Days of drinking per second interval of device wear | 0.74 percentage of days drinking | Standard Deviation 0.16 |
| Enhanced Usual Care | Percent of Days Drinking Per Interval of Device Wear | % Days of drinking per third interval of device wear | 0.42 percentage of days drinking | Standard Deviation 0.34 |
Improved Readiness for Alcohol Abstinence and Initiation of Change
Stages of Change Readiness & Treatment Eagerness Scale (SOCRATES) is a 19-item instrument that measures readiness for change assessing three areas; ambivalence, recognition, and taking steps with change scores assessing the impact of an intervention on these areas. Three subscale scores are produced with total scores ranging 19-95 and higher score indicating greater readiness: * 7 items for recognition of an alcohol problem (scores range from low of 7 to highest of 35) * 4 items for ambivalence (range from low of 4 to highest of 20) * 8 items for taking steps to make a positive change in drinking (range from low of 8 to highest of 40)
Time frame: Scores determined at initiation, 6 weeks and 3 months of participation
Population: numbers at follow up assessments are different than initially enrolled due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | SOCRATES Total Score: Intake assessment | 82 score on a scale | Standard Deviation 7 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Recognition: intake | 32 score on a scale | Standard Deviation 3 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Ambivalence: intake | 14 score on a scale | Standard Deviation 5 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Taking Steps: intake | 35 score on a scale | Standard Deviation 3 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | SOCRATES Total Score: 6 week assessment | 72 score on a scale | Standard Deviation 9 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Recognition: 6 weeks | 27 score on a scale | Standard Deviation 5 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Ambivalence: 6 weeks | 9 score on a scale | Standard Deviation 4 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Taking Steps: 6 weeks | 28 score on a scale | Standard Deviation 5 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | SOCRATES Total Score: 3 Month assessment | 70 score on a scale | Standard Deviation 6 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Recognition: 3 months | 24 score on a scale | Standard Deviation 5 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Ambivalence: 3 months | 9 score on a scale | Standard Deviation 4 |
| Feedback | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Taking Steps: 3 months | 28 score on a scale | Standard Deviation 4 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Ambivalence: 3 months | 13 score on a scale | Standard Deviation 5 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | SOCRATES Total Score: Intake assessment | 79 score on a scale | Standard Deviation 14 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Ambivalence: 6 weeks | 13 score on a scale | Standard Deviation 4 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Recognition: intake | 31 score on a scale | Standard Deviation 6 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Recognition: 3 months | 28 score on a scale | Standard Deviation 7 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Ambivalence: intake | 13 score on a scale | Standard Deviation 4 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Taking Steps: 6 weeks | 33 score on a scale | Standard Deviation 4 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Taking Steps: intake | 34 score on a scale | Standard Deviation 5 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Taking Steps: 3 months | 31 score on a scale | Standard Deviation 5 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | SOCRATES Total Score: 6 week assessment | 77 score on a scale | Standard Deviation 13 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | SOCRATES Total Score: 3 Month assessment | 73 score on a scale | Standard Deviation 15 |
| Enhanced Usual Care | Improved Readiness for Alcohol Abstinence and Initiation of Change | Subscale Recognition: 6 weeks | 31 score on a scale | Standard Deviation 6 |
Medical Outcomes
AALD related hospitalizations and ER visits - total count of participants in each arm who experienced these outcomes
Time frame: Counts determined at initiation, 6 weeks and 3 months of participation
Population: Two participants in the EUC arm had died by the 3 month assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Feedback | Medical Outcomes | Intake assessment: Count of participants in emergency room in prior 90 days | 5 Participants |
| Feedback | Medical Outcomes | 6 week assessment: Count of participants in emergency room between intake and 6 week assessment | 4 Participants |
| Feedback | Medical Outcomes | Intake assessment: Count of participants hospitalized in prior 90 days | 14 Participants |
| Feedback | Medical Outcomes | 6 week assessment: Count of participants hospitalized between intake and 6 week assessment | 6 Participants |
| Feedback | Medical Outcomes | 3 month assessment: Count of participants in emergency room between 6 week and 3 month assessment | 2 Participants |
| Feedback | Medical Outcomes | 3 month assessment: Count of participants hospitalized between 6 week and 3 month assessment | 2 Participants |
| Enhanced Usual Care | Medical Outcomes | 3 month assessment: Count of participants in emergency room between 6 week and 3 month assessment | 3 Participants |
| Enhanced Usual Care | Medical Outcomes | Intake assessment: Count of participants hospitalized in prior 90 days | 12 Participants |
| Enhanced Usual Care | Medical Outcomes | Intake assessment: Count of participants in emergency room in prior 90 days | 2 Participants |
| Enhanced Usual Care | Medical Outcomes | 6 week assessment: Count of participants hospitalized between intake and 6 week assessment | 6 Participants |
| Enhanced Usual Care | Medical Outcomes | 6 week assessment: Count of participants in emergency room between intake and 6 week assessment | 5 Participants |
| Enhanced Usual Care | Medical Outcomes | 3 month assessment: Count of participants hospitalized between 6 week and 3 month assessment | 2 Participants |
Qualitative Interviews
Qualitative interviews of participants will use a semi-structured script of open-ended stem questions with prompts. The qualitative assessment will cover such topics as patients' perceived need/psychologic barriers (e.g., beliefs in value of ABM in their clinical care and for their relationship with clinicians) and experience with ABM (e.g., wearability, satisfaction, and barriers to monitoring). Transcribed interviews will be thematically coded. The constant comparison method will be used, and subsequent interviews may be modified/informed by findings from previous interviews to explore emerging themes as the analysis proceeds.
Time frame: measured at three months (completion of the participants use of ABM)
Population: Includes 21 participants who completed the study and 2 additional participants who had to withdraw prior to completing the full study but were able to complete the qualitative interview. The purpose of qualitative interviews was to determine themes across both groups not between groups. We assigned qualitative data its own separate purpose within the larger project. We did not plan to quantitatively analyze the qualitative data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Feedback | Qualitative Interviews | Positive Usability examples: comfortable, no interference activities/lifestyle/sleep, easy to wear | 6 Themes |
| Feedback | Qualitative Interviews | Positive Acceptability example: looks didn't bother, didn't feel self-conscious, didn't hide purpose | 8 Themes |
| Feedback | Qualitative Interviews | Positive Feasibility examples: willing to wear, didn't take off, wouldn't change dr relationship | 7 Themes |
| Feedback | Qualitative Interviews | Positive Efficiency examples: benefit if prescribed, improve honesty, more data/ better/ accurate | 6 Themes |
| Feedback | Qualitative Interviews | Positive Impact of device on behavior examples: visual deterrent, accountability, therapeutic value | 10 Themes |
| Feedback | Qualitative Interviews | Positive Preferences, Facilitators, or Barriers: helpful if dr prescribed, gives proof not drinking | 9 Themes |
| Feedback | Qualitative Interviews | Negative Usability examples: uncomfortable/cumbersome/annoying, interfered with sleep | 7 Themes |
| Feedback | Qualitative Interviews | Negative Acceptability examples: conspicuous, felt self-conscious, appearance not optimal | 4 Themes |
| Feedback | Qualitative Interviews | Negative Feasibility examples: had to take off for a lot of activities/ to avoid damaging | 6 Themes |
| Feedback | Qualitative Interviews | Negative Efficiency examples: Wouldn't improve medical care, already honest about alcohol use | 2 Themes |
| Feedback | Qualitative Interviews | Negative Impact of device on behavior examples: can't prevent drinking, have to buy into concept | 5 Themes |
| Feedback | Qualitative Interviews | Negative Preferences, Facilitators, or Barriers: potential negative feelings/stigma/reminder | 8 Themes |
Self Efficacy to Remain Abstinent
Alcohol Abstinence Self-efficacy (AASE) evaluates confidence in ability to abstain from drinking in situations that represent typical drinking cues. Four subscales with 5 specific situations each are rated on confidence not to drink in each situations on a 5-point Likert scale from 1=not at all confident to 5=extremely confident. Total scores range from 20-100 with higher scores reflecting greater self confidence not to drink. * negative affect situations (range from low confidence of 5 to highest confidence of 25) * social/positive situations (range from low confidence of 5 to highest confidence of 25) * physical and other concerns situations (range from low confidence of 5 to highest confidence of 25) * cravings and urges situations (range from low confidence of 5 to highest confidence of 25)
Time frame: Scores determined at initiation, 6 weeks and 3 months of participation
Population: numbers at follow up assessments are different than initially enrolled due to drop out
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Feedback | Self Efficacy to Remain Abstinent | Subscale Withdrawal Urges: intake | 19 score on a scale | Standard Deviation 5 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Physical Concern: 6 weeks | 23 score on a scale | Standard Deviation 2 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Negative Affect: intake | 20 score on a scale | Standard Deviation 5 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Withdrawal Urges: 6 weeks | 21 score on a scale | Standard Deviation 3 |
| Feedback | Self Efficacy to Remain Abstinent | Alcohol Self Efficacy Scale: 6 week assessment | 88 score on a scale | Standard Deviation 10 |
| Feedback | Self Efficacy to Remain Abstinent | Alcohol Self Efficacy Scale: 3 month assessment | 91 score on a scale | Standard Deviation 11 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Physical Concern: intake | 22 score on a scale | Standard Deviation 3 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Negative Affect: 3 months | 22 score on a scale | Standard Deviation 4 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Negative Affect: 6 weeks | 21 score on a scale | Standard Deviation 3 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Social Positive: 3 months | 23 score on a scale | Standard Deviation 3 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Social Positive: intake | 21 score on a scale | Standard Deviation 4 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Physical Concern: 3 months | 24 score on a scale | Standard Deviation 2 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Social Positive: 6 weeks | 23 score on a scale | Standard Deviation 3 |
| Feedback | Self Efficacy to Remain Abstinent | Subscale Withdrawal Urges: 3 months | 23 score on a scale | Standard Deviation 3 |
| Feedback | Self Efficacy to Remain Abstinent | Alcohol Self Efficacy Scale: Intake assessment | 82 score on a scale | Standard Deviation 15 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Withdrawal Urges: 3 months | 19 score on a scale | Standard Deviation 8 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Alcohol Self Efficacy Scale: Intake assessment | 85 score on a scale | Standard Deviation 25 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Negative Affect: intake | 21 score on a scale | Standard Deviation 7 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Social Positive: intake | 21 score on a scale | Standard Deviation 7 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Physical Concern: intake | 22 score on a scale | Standard Deviation 6 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Withdrawal Urges: intake | 22 score on a scale | Standard Deviation 6 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Alcohol Self Efficacy Scale: 6 week assessment | 83 score on a scale | Standard Deviation 26 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Negative Affect: 6 weeks | 20 score on a scale | Standard Deviation 7 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Social Positive: 6 weeks | 20 score on a scale | Standard Deviation 7 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Physical Concern: 6 weeks | 21 score on a scale | Standard Deviation 6 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Withdrawal Urges: 6 weeks | 21 score on a scale | Standard Deviation 6 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Alcohol Self Efficacy Scale: 3 month assessment | 77 score on a scale | Standard Deviation 30 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Negative Affect: 3 months | 20 score on a scale | Standard Deviation 7 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Social Positive: 3 months | 18 score on a scale | Standard Deviation 9 |
| Enhanced Usual Care | Self Efficacy to Remain Abstinent | Subscale Physical Concern: 3 months | 20 score on a scale | Standard Deviation 6 |