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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA023650 | 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 5-arm randomized trial to determine what components of a text message intervention are necessary to reduce hazardous drinking among young adults and mechanisms through which these changes occur.
Young adults ages 18-25 have high rates of hazardous alcohol use and alcohol-related consequences. The Emergency Department (ED) provides an important opportunity to identify young adult hazardous drinkers who could benefit from interventions. A Text Message (TM) intervention was shown to reduce alcohol consumption among young adult ED patients, showing durable effects over 9-months. The TM intervention uses behavior change techniques with the largest effect sizes in an alcohol intervention meta-analysis: "goal commitment" and "self-monitoring", along with real-time "feedback". However, the unique effect of these ingredients, and mechanisms (processes occurring within the individual) through which they operate to reduce drinking remain unclear, a critical gap addressed by this project. Young adult ED patients (ages 18-25) who screen positive for hazardous drinking will be recruited to participate in a randomized trial to determine how best to help individuals reduce hazardous drinking. All participants will be asked to complete web-based surveys at baseline, 12 and 24 weeks after enrollment, complete brief psychomotor tasks weekly for 14 weeks, and respond to text messages each Thursday and Sunday for the next 12 weeks. Those randomized to the TM interventions will additionally receive feedback on their text reports. The four TM intervention arms are: (1) Drinking Cognition Feedback (DCF), (2) Alcohol Risk Feedback (ARF), (3) Adaptive Goal Support (AGS) and (4) a combination of DCF, ARF, and AGS=COMBO). Study results have implications for designing efficient mobile interventions, and developing a dynamic theory of behavior change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drinking Cognition Feedback (DCF) | Experimental | 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). |
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| Alcohol Risk Feedback (ARF) | Experimental | 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). |
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| Adaptive Goal Support (AGS) | Experimental | 10 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed). |
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| COMBO | Experimental | 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. |
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| Control | No Intervention | 12 weeks of text message assessments without any feedback |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drinking Cognition Feedback (DCF) | Behavioral | 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Binge Drinking Days | Measured by the # days on the Timeline Followback Calendar that a male reported 5+ drinks or a female reported 4+ drinks | 12 weeks after starting intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Drinks Per Drinking Day | drinks per drinking day = mean drinks divided by the number of days with any alcohol consumption using the 30-day TLFB Calendar. | 12 weeks after starting intervention |
| Count of Participants With Any Binge Drinking Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Suffoletto, MD MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center Emergency Department | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39505110 | Derived | Chung T, Suffoletto B, Bhurosy T. Which intervention works for whom: Identifying pre-treatment characteristics that predict who will benefit from a specific alcohol text message intervention from a randomized trial. J Subst Use Addict Treat. 2025 Jan;168:209562. doi: 10.1016/j.josat.2024.209562. Epub 2024 Nov 4. | |
| 36809294 | Derived | Bae SW, Suffoletto B, Zhang T, Chung T, Ozolcer M, Islam MR, Dey AK. Leveraging Mobile Phone Sensors, Machine Learning, and Explainable Artificial Intelligence to Predict Imminent Same-Day Binge-drinking Events to Support Just-in-time Adaptive Interventions: Algorithm Development and Validation Study. JMIR Form Res. 2023 May 4;7:e39862. doi: 10.2196/39862. |
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De-identified dataset provided upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | COMBO | 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. COMBO: 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. |
| FG001 | Adaptive Goal Support (AGS) | 12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed). Adaptive Goal Support (AGS): 12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed). |
| FG002 | Alcohol Risk Feedback (ARF) | 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). Alcohol Risk Feedback (ARF): 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). |
| FG003 | Drinking Cognition Feedback (DCF) | 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). Drinking Cognition Feedback (DCF): 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). |
| FG004 | Control | 12 weeks of text message assessments without any feedback |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | COMBO | 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. COMBO: 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. |
| BG001 | Adaptive Goal Support (AGS) |
| 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, Continuous | Mean |
| 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 | Number of Binge Drinking Days | Measured by the # days on the Timeline Followback Calendar that a male reported 5+ drinks or a female reported 4+ drinks | CCA | Posted | Mean | Standard Deviation | days | 12 weeks after starting intervention |
|
6-months
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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 | COMBO | 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. COMBO: 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Suffoletto | Stanford University | 4129016892 | suffbp@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2017 | Jun 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Alcohol Risk Feedback (ARF) | Behavioral | 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). |
|
| Adaptive Goal Support (AGS) | Behavioral | 12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed). |
|
| COMBO | Behavioral | 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. |
|
Using the Timeline Followback Calendar, any male participant reported one or more days with 5+ drinks or a female with one or more days with 4+ drinks are coded=1; otherwise participant is coded=0
| 12 weeks after starting intervention |
| Brief Young Adult Alcohol Consequences Questionnaire Score | Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ). The B-YAACQ is a 24-item measure of alcohol- related problems that utilizes a dichotomous (present or absent) scoring format. Sum of items 1-48. Higher scores (count of items marked as 'present') on the B-YAACQ not only indicate a wider variety but also reflect a more severe pattern of alcohol-related problems. | 12 weeks after starting intervention |
| 31886700 | Derived | Suffoletto B, Field M, Chung T. Attentional and approach biases to alcohol cues among young adult drinkers: An ecological momentary assessment study. Exp Clin Psychopharmacol. 2020 Dec;28(6):649-658. doi: 10.1037/pha0000343. Epub 2019 Dec 30. |
12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
Adaptive Goal Support (AGS): 12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
| BG002 | Alcohol Risk Feedback (ARF) | 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). Alcohol Risk Feedback (ARF): 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). |
| BG003 | Drinking Cognition Feedback (DCF) | 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). Drinking Cognition Feedback (DCF): 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). |
| BG004 | Control | 12 weeks of text message assessments without any feedback |
| BG005 | Total | Total of all reporting groups |
| 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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| Any tobacco use | Number | participants |
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| Impulsivity score | Participants completed the Short Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency (S-UPPS-P) scale. 20 items rated on a four-point Likert scale: (1) disagree strongly, (2) disagree some, (3) agree some, and (4) agree strongly. Five scales were computed by adding the 4 items corresponding to each scale: (1) negative urgency (NU), (2) positive urgency (PU), (3) sensation seeking (SS), (4) lack of perseveration (PE), and (5) lack of premeditation (PR). Range of total impulsivity (summary) score 20 to 80 with higher values representing more impulsivity. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Alcohol Risk Feedback (ARF) | 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). Alcohol Risk Feedback (ARF): 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). |
| OG003 | Drinking Cognition Feedback (DCF) | 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). Drinking Cognition Feedback (DCF): 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). |
| OG004 | Control | 12 weeks of text message assessments without any feedback |
|
|
| Secondary | Drinks Per Drinking Day | drinks per drinking day = mean drinks divided by the number of days with any alcohol consumption using the 30-day TLFB Calendar. | Posted | Mean | Standard Deviation | drinks/day | 12 weeks after starting intervention |
|
|
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| Secondary | Count of Participants With Any Binge Drinking Day | Using the Timeline Followback Calendar, any male participant reported one or more days with 5+ drinks or a female with one or more days with 4+ drinks are coded=1; otherwise participant is coded=0 | Posted | Count of Participants | Participants | 12 weeks after starting intervention |
|
|
|
| Secondary | Brief Young Adult Alcohol Consequences Questionnaire Score | Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ). The B-YAACQ is a 24-item measure of alcohol- related problems that utilizes a dichotomous (present or absent) scoring format. Sum of items 1-48. Higher scores (count of items marked as 'present') on the B-YAACQ not only indicate a wider variety but also reflect a more severe pattern of alcohol-related problems. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks after starting intervention |
|
|
|
| 0 |
| 220 |
| 0 |
| 220 |
| 0 |
| 220 |
| EG001 | Adaptive Goal Support (AGS) | 10 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed). Adaptive Goal Support (AGS): 12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed). | 0 | 213 | 0 | 213 | 0 | 213 |
| EG002 | Alcohol Risk Feedback (ARF) | 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). Alcohol Risk Feedback (ARF): 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). | 0 | 232 | 0 | 232 | 0 | 232 |
| EG003 | Drinking Cognition Feedback (DCF) | 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). Drinking Cognition Feedback (DCF): 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). | 0 | 224 | 0 | 224 | 0 | 224 |
| EG004 | Control | 12 weeks of text message assessments without any feedback | 0 | 242 | 0 | 242 | 0 | 242 |
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