Alcohol AbuseTransitionsNCT00852033
Alcohol Early Intervention for Freshmen
A study testing Brief Motivational Intervention (BMI), Parent Based Intervention plus booster and Combined brief motivational intervention and parent based intervention plus boosters for both interventions in people with Alcohol Abuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Alcohol abuse among college students is a significant and long-standing public health issue. The transition into college is marked by substantial increases in alcohol abuse and problems, suggesting the importance of interventions that take place prior to and immediately following matriculation. Read more about this study
- Who is it for?
- Ages 17 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Brief Motivational Intervention (BMI), Parent Based Intervention plus booster and Combined brief motivational intervention and parent based intervention plus boosters for both interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,014 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jul 2009
- 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 17 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All incoming students who paid their university attendance deposit by May 1st of the recruitment years were eligible for participation.
Who cannot join
- transfer students,
- married,
- not living with a parent/guardian,
- returning students older than 20 years
- reached the alcohol use cut-off criteria (40 or more drinks per week and two symptoms of alcohol dependence)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rhode Island, Department of Psychology
Kingston, Rhode Island, 02881
About this study
Alcohol abuse among college students is a significant and long-standing public health issue. The transition into college is marked by substantial increases in alcohol abuse and problems, suggesting the importance of interventions that take place prior to and immediately following matriculation. To date, early interventions with this population have yielded modest results with very little evidence identifying either the factors that are responsible for observed effects or specific individual or situational factors that qualify intervention efficacy. There is preliminary evidence for the efficacy of individualized feedback (IF) in reducing college student alcohol abuse. Additionally, a sizeable body of research with early adolescents and emerging work with college students point to the utility of parent-based interventions (PBI). The major aim of this research is to provide the first test of the unique and combined efficacy of these two successful interventions in reducing alcohol abuse among matriculating college students.
Read the detailed description
Using a 2 X 2 IF (yes; no) X PBI (yes; no) factorial design, this study will determine whether IF and PBI with "boosters" are effective in reducing alcohol abuse among incoming college students. It is hypothesized that groups receiving IF and PBI will demonstrate lower levels of alcohol abuse over the first two years of college than those not receiving these interventions and that the effects of combining these interventions will be additive (Specific Aim 1). Structural equation modeling techniques will be used to conduct mediational analyses investigating theoretically derived hypotheses about the processes by which intervention factors influence alcohol use and problems (Specific Aim 2). Hierarchical multiple regression analyses will examine hypothesized individual and situational moderators of intervention efficacy (Specific Aim 3). The use of a factorial design and explicit mediational analyses will allow for very strong inferences regarding the "active ingredients" of intervention efficacy. The long-term objectives of this research are to improve the efficacy of early interventions and to inform research and theory on the etiology of alcoholism. More effective interventions, particularly those that target students during a developmental transition of enhanced risk, will result in fewer injuries from acute intoxication, enhance retention and learning, and lessen the development of alcoholism as a result of chronic alcohol abuse.
- Conditions
- Alcohol Abuse
- Being tested
- Brief Motivational Intervention (BMI), Parent Based Intervention plus booster, Combined brief motivational intervention and parent based intervention plus boosters for both interventions, Assessment only
- Keywords
- alcoholism, alcohol abuse, prevention, behavior modification, parent offspring interaction, university student, substance abuse related behavior, adolescence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational Intervention (BMI)Behavioural
Also called BMI
Students met with trained interventionists. The initial BMI took place during the fall semester of the freshmen year for approximately 45 minutes. Individualized feedback was used to guide the BMI sessions. The feedback data were gathered through an online survey completed within two weeks of the scheduled appointment to ensure the use of proximal feedback reflecting current drinking. Feedback was tailored so that drinkers received information on their personal drinking patterns, heavy episodic drinking, and alcohol-related consequences, and abstainers received feedback on their perceived barriers for maintaining abstinence, the safety and health benefits of their choice not to drink, and their experience with second-hand effects of alcohol use. In the spring of the freshmen year, students received a BMI 'booster' session. Individualized feedback was created from the original online survey and the 10 month follow-up assessment.
Parent Based Intervention plus boosterBehavioural
Also called PBI
The PBI is a handbook-based intervention modified from Turrisi and colleagues (2001). It was designed to raise parental awareness of alcohol abuse and consequences among college students and increase parental effort to address this issue with their teen.
Combined brief motivational intervention and parent based intervention plus boosters for both interventionsBehavioural
A combination of Intervention 1 and 2.
Assessment onlyOther
No intervention, assessment only.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Assessment Group (no intervention) Receives: Other: Assessment only |
| 2 | Active comparator | Brief Motivational Intervention (BMI) Receives: Behavioral: Brief Motivational Intervention (BMI) |
| 3 | Active comparator | Parent Based Intervention (PBI) Receives: Behavioral: Parent Based Intervention plus booster |
| 4 | Active comparator | BMI and TBI Receives: Behavioral: Brief Motivational Intervention (BMI); Behavioral: Parent Based Intervention plus booster; Behavioral: Combined brief motivational intervention and parent based intervention plus boosters for both interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Drinking Questionnaire
Measured: Baseline, 10 months, 22months, 46 months
Young Adult Problems Screening Test "YAAPST"
Measured: Baseline, 10 months, 22months, 46months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJan 2004
- Primary completionJun 2007
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Mark D Wood, PhD, Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852033
- Sponsor's protocol ID
- NIAAA-Wood-AA013919
- Other IDs
- NIH Grant 5R01AA013919-04
- Acronym
- Transitions
- Status last verified
- Feb 2009
- First submitted
- 24 Feb 2009
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Early Intervention for Freshmen
- ClinicalTrials.gov ID
- NCT00852033
- Acronym / sponsor ID
- Transitions / NIAAA-Wood-AA013919
- Conditions
- Alcohol Abuse
- Keywords
- alcoholism, alcohol abuse, prevention, behavior modification, parent offspring interaction, university student, substance abuse related behavior, adolescence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,014 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Jan 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2009 (estimated)
- First posted
- 26 Feb 2009 (estimated)
- 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.
Alcohol abuse among college students is a significant and long-standing public health issue. The transition into college is marked by substantial increases in alcohol abuse and problems, suggesting the importance of interventions that take place prior to and immediately following matriculation. To date, early interventions with this population have yielded modest results with very little evidence identifying either the factors that are responsible for observed effects or specific individual or situational factors that qualify intervention efficacy. There is preliminary evidence for the efficacy of individualized feedback (IF) in reducing college student alcohol abuse. Additionally, a sizeable body of research with early adolescents and emerging work with college students point to the utility of parent-based interventions (PBI). The major aim of this research is to provide the first test of the unique and combined efficacy of these two successful interventions in reducing alcohol abuse among matriculating college students.
Detailed description
Using a 2 X 2 IF (yes; no) X PBI (yes; no) factorial design, this study will determine whether IF and PBI with "boosters" are effective in reducing alcohol abuse among incoming college students. It is hypothesized that groups receiving IF and PBI will demonstrate lower levels of alcohol abuse over the first two years of college than those not receiving these interventions and that the effects of combining these interventions will be additive (Specific Aim 1). Structural equation modeling techniques will be used to conduct mediational analyses investigating theoretically derived hypotheses about the processes by which intervention factors influence alcohol use and problems (Specific Aim 2). Hierarchical multiple regression analyses will examine hypothesized individual and situational moderators of intervention efficacy (Specific Aim 3). The use of a factorial design and explicit mediational analyses will allow for very strong inferences regarding the "active ingredients" of intervention efficacy. The long-term objectives of this research are to improve the efficacy of early interventions and to inform research and theory on the etiology of alcoholism. More effective interventions, particularly those that target students during a developmental transition of enhanced risk, will result in fewer injuries from acute intoxication, enhance retention and learning, and lessen the development of alcoholism as a result of chronic alcohol abuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Other: Assessment onlyAssessment Group (no intervention) |
| 2 | Active comparator | Behavioral: Brief Motivational Intervention (BMI)Brief Motivational Intervention (BMI) |
| 3 | Active comparator | Behavioral: Parent Based Intervention plus boosterParent Based Intervention (PBI) |
| 4 | Active comparator | Behavioral: Brief Motivational Intervention (BMI), Behavioral: Parent Based Intervention plus booster, Behavioral: Combined brief motivational intervention and parent based intervention plus boosters for both interventionsBMI and TBI |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All incoming students who paid their university attendance deposit by May 1st of the recruitment years were eligible for participation.
Key exclusion criteria (5 listed)
- transfer students,
- married,
- not living with a parent/guardian,
- returning students older than 20 years
- reached the alcohol use cut-off criteria (40 or more drinks per week and two symptoms of alcohol dependence)
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 |
|---|---|---|
| Brief Motivational Intervention (BMI)Also: BMIStudents met with trained interventionists. The initial BMI took place during the fall semester of the freshmen year for approximately 45 minutes. Individualized feedback was used to guide the BMI sessions. The feedback data were gathered through an online survey completed within two weeks of the scheduled appointment to ensure the use of proximal feedback reflecting current drinking. Feedback was tailored so that drinkers received information on their personal drinking patterns, heavy episodic drinking, and alcohol-related consequences, and abstainers received feedback on their perceived barriers for maintaining abstinence, the safety and health benefits of their choice not to drink, and their experience with second-hand effects of alcohol use. In the spring of the freshmen year, students received a BMI 'booster' session. Individualized feedback was created from the original online survey and the 10 month follow-up assessment. | Behavioural | 2, 4 |
| Parent Based Intervention plus boosterAlso: PBIThe PBI is a handbook-based intervention modified from Turrisi and colleagues (2001). It was designed to raise parental awareness of alcohol abuse and consequences among college students and increase parental effort to address this issue with their teen. | Behavioural | 3, 4 |
| Combined brief motivational intervention and parent based intervention plus boosters for both interventionsA combination of Intervention 1 and 2. | Behavioural | 4 |
| Assessment onlyNo intervention, assessment only. | Other | 1 |
Primary outcome
Daily Drinking Questionnaire
Time frame: Baseline, 10 months, 22months, 46 months
Young Adult Problems Screening Test "YAAPST"
Time frame: Baseline, 10 months, 22months, 46months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
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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.
Mark D Wood, PhD principal investigator
University of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Intervention (BMI), Parent Based Intervention plus booster and Combined brief motivational intervention and parent based intervention plus boosters for both interventions in people with Alcohol Abuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Feb 2009. 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?
Results are not available in the source record.
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?
Daily Drinking Questionnaire (time frame: Baseline, 10 months, 22months, 46 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 26 Feb 2009.