Alcohol DrinkingNCT03381391
Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers
A study testing Personalized Feedback Intervention in people with Alcohol Drinking, run by Old Dominion University.
Trial summary
Emerging adulthood is a period of heightened vulnerability for problematic alcohol use. Considerable research has been devoted to reducing alcohol risks in college student populations, though far less effort has focused on their noncollege-attending peers. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Personalized Feedback Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2013to 2 Dec 2015
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study eligibility included being 18 to 25 years old, having no prior or current college attendance (e.g., technical/vocational programs, associate's degree programs, or four year college programs), and not being currently enrolled in high school. High school completion was not a required eligibility criteria. They also had to report engaging in a minimum of two heavy drinking episodes (i.e., 4/5+ standard drinks for women/men on one occasion) in the past month
Who cannot join
- Exclusion criteria included consumption above 40 drinks weekly and/or a history of substance use treatment
About this study
Emerging adulthood is a period of heightened vulnerability for problematic alcohol use. Considerable research has been devoted to reducing alcohol risks in college student populations, though far less effort has focused on their noncollege-attending peers. Research targeting nonstudent emerging adults is critical as this group is at risk for experiencing alcohol-related harms. Consequently, the main objective of the present study was to examine the preliminary efficacy of a brief personalized feedback intervention (PFI) tailored for nonstudent at-risk drinkers.
- Conditions
- Alcohol Drinking
- Being tested
- Personalized Feedback Intervention
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Feedback InterventionBehavioural
The current intervention included personalized feedback regarding their alcohol consumption, alcohol-related consequences, gender-specific normative drinking comparisons, personal risk factors (e.g., dependence symptoms, family history of alcoholism), and alcohol expectancies. The intervention also included didactic material related to alcohol (e.g., effects at different BAC levels, tolerance) and drinking moderation strategies. The feedback was presented graphically in a feedback report with the individual's information.
| Study group | Role | What they receive |
|---|---|---|
| Feedback intervention condition | Experimental | Not described Receives: Behavioral: Personalized Feedback Intervention |
| Assessment-only control condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use quantity
Alcohol consumption was assessed using the Daily Drinking Questionnaire (DDQ; Collins et al., 1985). Participants reported the number of standard drinks (e.g., 12-ounce beer, 5-ounce wine, or 1.5 ounce liquor) consumed and duration each day during a typical week in the past 3 months. Indices of weekly drinking derived from the DDQ were: total quantity, frequency of drinking days, number of heavy drinking days (days where 4/5+ drinks for women/men were consumed), proportion of heavy drinking days out of total drinking days, maximum number of drinks on the heaviest drinking day, and typical blood alcohol concentration (BAC; see Matthews \& Miller, 1979).
Measured: 9 months
Alcohol-related harms
Alcohol-related problems were measured by the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ; Kahler et al., 2005). The B-YAACQ is a 24-item, yes-no format questionnaire assessing negative drinking-related consequences experienced during the past month. Items were summed to create an overall score (ranging from 0 to 24), with higher scores indicating greater severity.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start10 Jul 2013
- Primary completion2 Dec 2015
- Study completion2 Dec 2015
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Barraco, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381391
- Sponsor's protocol ID
- 14-065; 15-091
- Status last verified
- Jan 2018
- First submitted
- 18 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers
- ClinicalTrials.gov ID
- NCT03381391
- Acronym / sponsor ID
- 14-065; 15-091
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 10 Jul 2013 (actual)
- Primary completion
- 2 Dec 2015 (actual)
- Study completion
- 2 Dec 2015 (actual)
- First posted
- 22 Dec 2017 (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.
Emerging adulthood is a period of heightened vulnerability for problematic alcohol use. Considerable research has been devoted to reducing alcohol risks in college student populations, though far less effort has focused on their noncollege-attending peers. Research targeting nonstudent emerging adults is critical as this group is at risk for experiencing alcohol-related harms. Consequently, the main objective of the present study was to examine the preliminary efficacy of a brief personalized feedback intervention (PFI) tailored for nonstudent at-risk drinkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback intervention condition | Experimental | Behavioral: Personalized Feedback Intervention |
| Assessment-only control condition | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Study eligibility included being 18 to 25 years old, having no prior or current college attendance (e.g., technical/vocational programs, associate's degree programs, or four year college programs), and not being currently enrolled in high school. High school completion was not a required eligibility criteria. They also had to report engaging in a minimum of two heavy drinking episodes (i.e., 4/5+ standard drinks for women/men on one occasion) in the past month
Key exclusion criteria (1 listed)
- Exclusion criteria included consumption above 40 drinks weekly and/or a history of substance use treatment
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 |
|---|---|---|
| Personalized Feedback InterventionThe current intervention included personalized feedback regarding their alcohol consumption, alcohol-related consequences, gender-specific normative drinking comparisons, personal risk factors (e.g., dependence symptoms, family history of alcoholism), and alcohol expectancies. The intervention also included didactic material related to alcohol (e.g., effects at different BAC levels, tolerance) and drinking moderation strategies. The feedback was presented graphically in a feedback report with the individual's information. | Behavioural | Feedback intervention condition |
Primary outcome
Alcohol use quantity
Time frame: 9 months
Alcohol consumption was assessed using the Daily Drinking Questionnaire (DDQ; Collins et al., 1985). Participants reported the number of standard drinks (e.g., 12-ounce beer, 5-ounce wine, or 1.5 ounce liquor) consumed and duration each day during a typical week in the past 3 months. Indices of weekly drinking derived from the DDQ were: total quantity, frequency of drinking days, number of heavy drinking days (days where 4/5+ drinks for women/men were consumed), proportion of heavy drinking days out of total drinking days, maximum number of drinks on the heaviest drinking day, and typical blood alcohol concentration (BAC; see Matthews \& Miller, 1979).
Alcohol-related harms
Time frame: 9 months
Alcohol-related problems were measured by the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ; Kahler et al., 2005). The B-YAACQ is a 24-item, yes-no format questionnaire assessing negative drinking-related consequences experienced during the past month. Items were summed to create an overall score (ranging from 0 to 24), with higher scores indicating greater severity.
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 4 Jan 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Feedback Intervention in people with Alcohol Drinking, run by Old Dominion University.
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 1 inclusion and 1 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Alcohol use quantity (time frame: 9 months). 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 4 Jan 2018.