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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AA028074 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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A total of 120 young adults who drink to cope with negative affect will be randomized to a 4-week, web-based intervention with interactive modules on cognitive-behavioral skills (n=60) or an assessment only control (n=60). Participants will complete 4 weekly assessments and a 1- and 3-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. |
|
| Assessment Control | No Intervention | A total of 60 young adults will be randomized to the assessment only control condition. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drinking to Cope CBT skills | Behavioral | Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use-Peak Drinks | Peak number of drinks; Item measuring peak alcohol consumption, "Think of the occasion you drank the most this past month. How much did you drink?", response options ranged from 0 (0 drinks) to 25 (25+ drinks); | past month |
| Alcohol Use-drinks Per Week | The DDQ (Collins, Parks, & Marlatt, 1985) was used to measure the quantity of alcohol consumed by asking participants to estimate the typical number of drinks consumed on each day of the week, on average during the past month. A sum score of weekly total drinks per week was then calculated as the sum of the total number of drinks per week reported. | past month |
| Alcohol Use-heavy Episodic Drinking | Heavy Episodic Drinking; NIAAA item assessing binge drinking, "During the past month, how often did you have [4 or more drinks (for women) /5 or more drinks (for men)] containing any kind of alcohol within a two-hour period?", response options ranged from 0 (Never) to 7 (Every day); | past month |
| Alcohol Negative Consequences | Alcohol Negative Consequences, Sum score (count) of negative consequences taken from Brief Young Adult Alcohol Consequences Questionnaire; Scores ranged from 0-24, with higher scores associated with more consequences. | Past Month |
| Alcohol Coping | The Drinking Motives Questionnaire-Revised (DMQR; Grant V.V., Stewart S.H., O'Connor R.M., Backwell E., & Conrod P.J. (2007). Psychometric evaluation of the five-factor Modified Drinking Motives Questionnaire-Revised in undergraduates. Addictive Behaviors, 32(11), 2611-2632. Doi: 10.1016/j.addbeh.2007.07.004 ) was used to assess reasons for drinking. Using a 5-point scale (ranging from 'almost never/never' to 'almost always/always' participants rate how frequently they use alcohol for various reasons. The alcohol coping motives subscale was used which takes the average of the 9 items on the coping-depression subscale. Average scores ranged from 1-5, with higher scores are associated with greater use of coping. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | depressive symptoms; The eight-item Patient Health Questionnaire depression scale (PHQ-8) was used to assess for symptoms of depression. A sum of the 8 items was used, with the summed score ranging from 0-24. Higher scores represent greater symptoms of depression. | Past month |
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Inclusion Criteria:
- Eligibility criteria at recruitment include: 1)18-25 years old; 2) Currently live in the state of WA, 3) Have a valid email address and phone number, 4) Drank alcohol at least once in the past month, 5) report at least 1 alcohol-related problem in the past month, 6) report using alcohol to cope with distress via negative reinforcement (i.e., to provide relief or reduction of stress or depressed mood) in the past month
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M Cadigan, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills |
| FG001 | Assessment Control | A total of 60 young adults will be randomized to the assessment only control condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills |
| BG001 | Assessment Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Use-Peak Drinks | Peak number of drinks; Item measuring peak alcohol consumption, "Think of the occasion you drank the most this past month. How much did you drink?", response options ranged from 0 (0 drinks) to 25 (25+ drinks); | Posted | Mean | Standard Deviation | number of drinks | past month |
|
Data was collected over a 4 month period.
The definition of adverse event and serious adverse event does not differ from the clinicialtrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | A total of 60 young adults will be randomized to the 4-week, web-based drinking to cope intervention. Drinking to Cope CBT skills: Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Cadigan | University of Washington | 206-543-5689 | cadiganj@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2022 | Mar 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2024 | Sep 8, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| Past Month |
A total of 60 young adults will be randomized to the assessment only control condition. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Alcohol Use-drinks Per Week | The DDQ (Collins, Parks, & Marlatt, 1985) was used to measure the quantity of alcohol consumed by asking participants to estimate the typical number of drinks consumed on each day of the week, on average during the past month. A sum score of weekly total drinks per week was then calculated as the sum of the total number of drinks per week reported. | Posted | Mean | Standard Deviation | drinks per week | past month |
|
|
|
|
| Primary | Alcohol Use-heavy Episodic Drinking | Heavy Episodic Drinking; NIAAA item assessing binge drinking, "During the past month, how often did you have [4 or more drinks (for women) /5 or more drinks (for men)] containing any kind of alcohol within a two-hour period?", response options ranged from 0 (Never) to 7 (Every day); | Posted | Mean | Standard Deviation | score on a scale | past month |
|
|
|
|
| Primary | Alcohol Negative Consequences | Alcohol Negative Consequences, Sum score (count) of negative consequences taken from Brief Young Adult Alcohol Consequences Questionnaire; Scores ranged from 0-24, with higher scores associated with more consequences. | Posted | Mean | Standard Deviation | number of consequences | Past Month |
|
|
|
|
| Primary | Alcohol Coping | The Drinking Motives Questionnaire-Revised (DMQR; Grant V.V., Stewart S.H., O'Connor R.M., Backwell E., & Conrod P.J. (2007). Psychometric evaluation of the five-factor Modified Drinking Motives Questionnaire-Revised in undergraduates. Addictive Behaviors, 32(11), 2611-2632. Doi: 10.1016/j.addbeh.2007.07.004 ) was used to assess reasons for drinking. Using a 5-point scale (ranging from 'almost never/never' to 'almost always/always' participants rate how frequently they use alcohol for various reasons. The alcohol coping motives subscale was used which takes the average of the 9 items on the coping-depression subscale. Average scores ranged from 1-5, with higher scores are associated with greater use of coping. | Posted | Mean | Standard Deviation | score on a scale | Past Month |
|
|
|
|
| Secondary | Depressive Symptoms | depressive symptoms; The eight-item Patient Health Questionnaire depression scale (PHQ-8) was used to assess for symptoms of depression. A sum of the 8 items was used, with the summed score ranging from 0-24. Higher scores represent greater symptoms of depression. | Posted | Mean | Standard Deviation | score on a scale | Past month |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Assessment Control | A total of 60 young adults will be randomized to the assessment only control condition. | 0 | 60 | 0 | 60 | 0 | 60 |
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