Alcohol DrinkingNCT03583515
Evaluating Within-Person and Between-Person Effects Of A Personalized Normative Feedback Intervention On Drinking As They Are Moderated By Self-Determination
A study testing Alcohol-Specific Personalized Normative Feedback and Social Media Personalized Normative Feedback in people with Alcohol Drinking, run by University of Houston at 1 site in United States.
Trial summary
This study evaluates within-person and between-person effects of a personalized normative feedback intervention and injunctive norms as they are altered by self-determination in heavy drinkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Alcohol-Specific Personalized Normative Feedback and Social Media Personalized Normative Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to 31 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Student at the University of Houston
- Above 18 years of age
- Heavy drinker (more than 4 drinks [women] or 5 drinks [men] on a single occasion in the last 2.5 weeks and drinks, on average, at least once per week.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Determination Theory as A Framework For Evaluating Within-Person Effects Of Personalized Normative Feedback On Drinking
This study evaluates within-person and between-person effects of a personalized normative feedback intervention and injunctive norms as they are altered by self-determination in heavy drinkers. Half of participants will receive personalized normative feedback and the other half will receive control feedback about media use habits.
- Conditions
- Alcohol Drinking
- Being tested
- Alcohol-Specific Personalized Normative Feedback, Social Media Personalized Normative Feedback
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-Specific Personalized Normative FeedbackBehavioural
Participants will receive personalized normative feedback about drinking.
Social Media Personalized Normative FeedbackBehavioural
Participants will receive personalized normative feedback about social media use.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-Specific Personalized Normative Feedback | Experimental | Participants will receive feedback about their average number of days on which alcohol was consumed, average drinks per occasion, and average number of drinks per week. This feedback will include the participant's averages reported at baseline, the participant's descriptive norm of others' averages (what they think others drank), and actual others' drinking. Feedback will be about other students at their university of the same sex. Receives: Behavioral: Alcohol-Specific Personalized Normative Feedback |
| Social Media Personalized Normative Feedback | Placebo comparator | Participants will receive feedback about their number of hours texting, on social media websites, and playing video games. This feedback will include the participant's averages reported at baseline, the participant's descriptive norm of others' averages (what they think others did), and actual others' behavior. Feedback will be about other students at their university of the same sex. Receives: Behavioral: Social Media Personalized Normative Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-Person Self-Determination by PNF Interaction Predicting Consumption
A structural equation model will be fit with baseline consumption, self-determination, intervention condition, and the interaction between self-determination and condition predicting follow-up alcohol consumption. Consumption will be measured with the Alcohol Consumption Index, Quantity-Frequency-Peak Alcohol Use Index, and the Daily Drinking Questionnaire. These scales will be used as indicators of a single latent consumption variable. That latent consumption measure will be the outcome of interest.
Measured: 2-4 Weeks
Within-Person Self-Determination by PNF Interaction Predicting Consumption
A multilevel model will be fit with baseline consumption, daily self determination, intervention condition, and the interaction between condition and daily self-determination predicting daily alcohol consumption. Consumption will be measured as the number of drinks consumed the previous evening.
Measured: 17 Days
Secondary outcomes (2)
Between-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
A structural equation model will be fit with baseline consumption, alcohol-related problems, self-determination, intervention condition, and the interaction between self-determination and condition predicting follow-up alcohol-related problems. Alcohol-related problems will be measured with the Rutgers Alcohol Problems Index and the Young Adult Alcohol Consequences Questionnaire. Each of these problems measures will be split to form two indicators (for a total of four problems indicators) for an overall problems latent variable. This problems latent variable will then be used as the outcome of interest.
Measured: 2-4 Weeks
Within-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
A multilevel model will be fit with baseline consumption, daily self determination, intervention condition, and the interaction between condition and daily self-determination predicting daily alcohol alcohol-related problems. Alcohol-related problems will be measured with a checklist of non-overlapping items from the Rutgers Alcohol Problems Index and the Young Adult Alcohol Consequences Questionnaire. This combined checklist will be used to create the overall problems outcome of interest.
Measured: 17 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start25 Apr 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half of participants will be randomly assigned to receive personalized normative feedback about their drinking. The other half will be randomly assigned to receive control feedback about social media use.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, C. Raymond Knee, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583515
- Sponsor's protocol ID
- 1F31AA026195-01A1
- Other IDs
- 1F31AA026195-01A1
- Status last verified
- Apr 2020
- First submitted
- 1 Jun 2018
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Informed Consent Form Analytic Code De-Identified Data
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Determination Theory as A Framework For Evaluating Within-Person Effects Of Personalized Normative Feedback On Drinking
- ClinicalTrials.gov ID
- NCT03583515
- Acronym / sponsor ID
- 1F31AA026195-01A1
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 11 Jul 2018 (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.
This study evaluates within-person and between-person effects of a personalized normative feedback intervention and injunctive norms as they are altered by self-determination in heavy drinkers. Half of participants will receive personalized normative feedback and the other half will receive control feedback about media use habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Half of participants will be randomly assigned to receive personalized normative feedback about their drinking. The other half will be randomly assigned to receive control feedback about social media use.
| Arm | Type | Receives |
|---|---|---|
| Alcohol-Specific Personalized Normative Feedback | Experimental | Behavioral: Alcohol-Specific Personalized Normative FeedbackParticipants will receive feedback about their average number of days on which alcohol was consumed, average drinks per occasion, and average number of drinks per week. This feedback will include the participant's averages reported at baseline, the participant's descriptive norm of others' averages (what they think others drank), and actual others' drinking. Feedback will be about other students at their university of the same sex. |
| Social Media Personalized Normative Feedback | Placebo comparator | Behavioral: Social Media Personalized Normative FeedbackParticipants will receive feedback about their number of hours texting, on social media websites, and playing video games. This feedback will include the participant's averages reported at baseline, the participant's descriptive norm of others' averages (what they think others did), and actual others' behavior. Feedback will be about other students at their university of the same sex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Student at the University of Houston
- Above 18 years of age
- Heavy drinker (more than 4 drinks [women] or 5 drinks [men] on a single occasion in the last 2.5 weeks and drinks, on average, at least once per week.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Alcohol-Specific Personalized Normative FeedbackParticipants will receive personalized normative feedback about drinking. | Behavioural | Alcohol-Specific Personalized Normative Feedback |
| Social Media Personalized Normative FeedbackParticipants will receive personalized normative feedback about social media use. | Behavioural | Social Media Personalized Normative Feedback |
Primary outcome
Between-Person Self-Determination by PNF Interaction Predicting Consumption
Time frame: 2-4 Weeks
A structural equation model will be fit with baseline consumption, self-determination, intervention condition, and the interaction between self-determination and condition predicting follow-up alcohol consumption. Consumption will be measured with the Alcohol Consumption Index, Quantity-Frequency-Peak Alcohol Use Index, and the Daily Drinking Questionnaire. These scales will be used as indicators of a single latent consumption variable. That latent consumption measure will be the outcome of interest.
Within-Person Self-Determination by PNF Interaction Predicting Consumption
Time frame: 17 Days
A multilevel model will be fit with baseline consumption, daily self determination, intervention condition, and the interaction between condition and daily self-determination predicting daily alcohol consumption. Consumption will be measured as the number of drinks consumed the previous evening.
2 secondary outcomes
Between-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
Time frame: 2-4 Weeks
Within-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
Time frame: 17 Days
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 2 Apr 2020.
- Individual participant dataSharing planned: Yes. Study Protocol Informed Consent Form Analytic Code De-Identified Data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol-Specific Personalized Normative Feedback and Social Media Personalized Normative Feedback in people with Alcohol Drinking, run by University of Houston 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 3 inclusion and 0 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 2 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
Between-Person Self-Determination by PNF Interaction Predicting Consumption (time frame: 2-4 Weeks). The study lists 2 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 2 Apr 2020.