Alcohol ConsumptionTRAMNCT05864235
Texting to Reduce Alcohol Misuse Pilot Trial
A study testing Goal Support (GS) and Coaching for Context-specific Peer Support (CCPS) in people with Alcohol Consumption, run by Stanford University at 1 site in United States.
Trial summary
The primary aims of this project are to determine the feasibility and acceptability of recruiting and retaining young adult binge drinkers online and using text messaging to provide weekly Goal Support (GS) or weekly GS + Coaching for Context-specific Peer Support (CCPS) on alcohol consumption. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Goal Support (GS) and Coaching for Context-specific Peer Support (CCPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- English reader
- Owns a mobile phone with SMS
- Hazardous alcohol consumption as measured by: "How many times in the past year have you had X or more drinks in a day?", where X is 5 for men and 4 for women, and a response of 1 or greater is considered at-risk
- At least in contemplative stage of change for reducing alcohol consumption
Who cannot join
- Currently enrolled or past enrollment in a 4-year college
- Pregnant or pregnancy plans in the next 3-months
- Current or planned treatment for alcohol or substance use disorder in next 3-months
Trial locations and contacts
1 site in 1 country.
About this study
The primary aims of this project are to determine the feasibility and acceptability of recruiting and retaining young adult binge drinkers online and using text messaging to provide weekly Goal Support (GS) or weekly GS + Coaching for Context-specific Peer Support (CCPS) on alcohol consumption. The secondary aims will determine effect sizes for GS and GS+CCPS groups relative to controls on alcohol consumption at 6- and 12-weeks to inform design of an adequately-powered trial.
- Conditions
- Alcohol Consumption
- Being tested
- Control, Goal Support (GS), Coaching for Context-specific Peer Support (CCPS)
- Keywords
- young adults, binge drinking, text message
- Medical subject headings
- Alcohol Drinking, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Each week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink.
Goal Support (GS)Behavioural
Each week for 6-weeks, GS group participants will receive prompts and tailored feedback and support focused on weekly drinking limit goal commitment \& confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure.
Coaching for Context-specific Peer Support (CCPS)Behavioural
Each week for 6-weeks, CCPS group participants will receive weekly motivation and strategies to enlist peer support during drinking episodes.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Each week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink. Receives: Behavioral: Control |
| Goal Support (GS) | Experimental | Each week for 6-weeks, GS group participants will compete identical weekly text message assessments to the control group and receive further prompts and tailored feedback and support focused on weekly drinking limit goal commitment \& confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure. Receives: Behavioral: Control; Behavioral: Goal Support (GS) |
| GS + Coaching for Context-specific Peer Support (CCPS) | Experimental | Each week for 6-weeks, CCPS group participants will compete identical weekly text message assessments and feedback to GS plus additionally will receive weekly motivation and strategies to enlist peer support during drinking episodes. Receives: Behavioral: Control; Behavioral: Goal Support (GS); Behavioral: Coaching for Context-specific Peer Support (CCPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The % of people screened to participants enrolled
Online recruitment efficiency
Measured: 2 months
The % of participants who complete both 6- and 12-week web-based assessments
Follow-up completion
Measured: 12 weeks
The % of SMS queries with valid responses
Response rates to SMS queries
Measured: 6 weeks
The % of participants who at least agree that the SMS program helped them reduce their drinking
A single question with response options: completely disagree to completely agree
Measured: 12 weeks
Secondary outcomes (6)
# Binge drinking days
Count of binge drinking days using TLFB 30-day calendar
Measured: 6-weeks
Binge drinking days
Count of binge drinking days using TLFB 30-day calendar
Measured: 12-weeks
Drinks per drinking day
Mean drinks per drinking day using TLFB 30-day calendar
Measured: 6-weeks
Drinks per drinking day
Mean drinks per drinking day using TLFB 30-day calendar
Measured: 12-weeks
# Alcohol negative consequences
B-YAACQ: 24 yes/no questions
Measured: 6-weeks
Alcohol negative consequences
B-YAACQ: 24 yes/no questions
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start4 May 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Suffoletto, Stanford University
- Investigators
- Brian Suffoletto, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864235
- Sponsor's protocol ID
- 67584
- Acronym
- TRAM
- Status last verified
- Nov 2024
- First submitted
- 28 Apr 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texting to Reduce Alcohol Misuse Pilot Trial
- ClinicalTrials.gov ID
- NCT05864235
- Acronym / sponsor ID
- TRAM / 67584
- Conditions
- Alcohol Consumption
- Keywords
- young adults, binge drinking, text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aims of this project are to determine the feasibility and acceptability of recruiting and retaining young adult binge drinkers online and using text messaging to provide weekly Goal Support (GS) or weekly GS + Coaching for Context-specific Peer Support (CCPS) on alcohol consumption. The secondary aims will determine effect sizes for GS and GS+CCPS groups relative to controls on alcohol consumption at 6- and 12-weeks to inform design of an adequately-powered trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlEach week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink. |
| Goal Support (GS) | Experimental | Behavioral: Control, Behavioral: Goal Support (GS)Each week for 6-weeks, GS group participants will compete identical weekly text message assessments to the control group and receive further prompts and tailored feedback and support focused on weekly drinking limit goal commitment \& confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure. |
| GS + Coaching for Context-specific Peer Support (CCPS) | Experimental | Behavioral: Control, Behavioral: Goal Support (GS), Behavioral: Coaching for Context-specific Peer Support (CCPS)Each week for 6-weeks, CCPS group participants will compete identical weekly text message assessments and feedback to GS plus additionally will receive weekly motivation and strategies to enlist peer support during drinking episodes. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English reader
- Owns a mobile phone with SMS
- Hazardous alcohol consumption as measured by: "How many times in the past year have you had X or more drinks in a day?", where X is 5 for men and 4 for women, and a response of 1 or greater is considered at-risk
- At least in contemplative stage of change for reducing alcohol consumption
Key exclusion criteria (3 listed)
- Currently enrolled or past enrollment in a 4-year college
- Pregnant or pregnancy plans in the next 3-months
- Current or planned treatment for alcohol or substance use disorder in next 3-months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlEach week for 6-weeks, control group participants will receive the following weekly text message assessments (without receiving any feedback or support): (1) Thursdays (3pm): weekend plans to drink and desire to get drunk; (2) Sundays (12pm): most drinks consumed on any weekend day and peer pressure to drink. | Behavioural | Control, GS + Coaching for Context-specific Peer Support (CCPS), Goal Support (GS) |
| Goal Support (GS)Each week for 6-weeks, GS group participants will receive prompts and tailored feedback and support focused on weekly drinking limit goal commitment \& confidence assessments and subsequently receive tailored feedback on goal success to either bolster future goal striving or reframe goal failure. | Behavioural | GS + Coaching for Context-specific Peer Support (CCPS), Goal Support (GS) |
| Coaching for Context-specific Peer Support (CCPS)Each week for 6-weeks, CCPS group participants will receive weekly motivation and strategies to enlist peer support during drinking episodes. | Behavioural | GS + Coaching for Context-specific Peer Support (CCPS) |
Primary outcome
The % of people screened to participants enrolled
Time frame: 2 months
Online recruitment efficiency
The % of participants who complete both 6- and 12-week web-based assessments
Time frame: 12 weeks
Follow-up completion
The % of SMS queries with valid responses
Time frame: 6 weeks
Response rates to SMS queries
The % of participants who at least agree that the SMS program helped them reduce their drinking
Time frame: 12 weeks
A single question with response options: completely disagree to completely agree
6 secondary outcomes
# Binge drinking days
Time frame: 6-weeks
Binge drinking days
Time frame: 12-weeks
Drinks per drinking day
Time frame: 6-weeks
Drinks per drinking day
Time frame: 12-weeks
# Alcohol negative consequences
Time frame: 6-weeks
Alcohol negative consequences
Time frame: 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Suffoletto principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Support (GS) and Coaching for Context-specific Peer Support (CCPS) in people with Alcohol Consumption, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The % of people screened to participants enrolled (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.