Alcohol ConsumptionGOALSNCT01126164
Parent Intervention to Reduce Binge Drinking
A study testing Parent Handbook and Peer Basics in people with Alcohol Consumption, run by Penn State University at 1 site in United States.
Trial summary
Parent and peer interventions to reduce student drinking Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Parent Handbook and Peer Basics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- varsity athlete in high school
Who cannot join
- not a varsity athlete in high school
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Parent and peer interventions to reduce student drinking
Read the detailed description
Parent and peer interventions to reduce student drinking:
Efficacy;
Mediation:
Moderation
- Conditions
- Alcohol Consumption
- Being tested
- Parent Handbook and Peer Basics
- Keywords
- parents, peer, basics, college student drinking
- Medical subject headings
- Alcohol Drinking, Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Handbook and Peer BasicsBehavioural
Also called Parent Handbook, Peer Delivered BASICS
Parent and Peer delivered interventions
| Study group | Role | What they receive |
|---|---|---|
| parent handbook | Experimental | parent handbook Receives: Behavioral: Parent Handbook and Peer Basics |
| peer basics | Experimental | peer delivered basics Receives: Behavioral: Parent Handbook and Peer Basics |
| parent handbook and peer basics | Experimental | parent handbook and peer basics Receives: Behavioral: Parent Handbook and Peer Basics |
What is being measured
The primary outcome is the main question the study is designed to answer.
heavy episodic drinking
typical daily drinking
Measured: 6 months post baseline
heavy episodic drinking
typical daily drinking
Measured: 9 months post baseline
heavy episodic peak drinking
peak number of drinks in one night
Measured: 6 months post baseline
heavy episodic peak drinking
peak number of drinks in one night
Measured: 9 months post baseline
Secondary outcomes (1)
drinking consequences
frequency of blackouts, hangovers, vomiting, fights, unplanned sex, trouble with police, poor academic performance as measured by the rapi; yaapst (standard instruments used in all college alcohol prevention trials)
Measured: 9 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startSep 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Turrisi, Penn State University
- Investigators
- Robert Turrisi, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126164
- Sponsor's protocol ID
- R01AA012529
- Acronym
- GOALS
- Status last verified
- Mar 2021
- First submitted
- 17 May 2010
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Turrisi R, Larimer ME, Mallett KA, Kilmer JR, Ray AE, Mastroleo NR, Geisner IM, Grossbard J, Tollison S, Lostutter TW, Montoya H. A randomized clinical trial evaluating a combined alcohol intervention for high-risk college students. J Stud Alcohol Drugs. 2009 Jul;70(4):555-67. doi: 10.15288/jsad.2009.70.555.
PubMed 19515296
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Intervention to Reduce Binge Drinking
- ClinicalTrials.gov ID
- NCT01126164
- Acronym / sponsor ID
- GOALS / R01AA012529
- Conditions
- Alcohol Consumption
- Keywords
- parents, peer, basics, college student drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 May 2010 (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.
Parent and peer interventions to reduce student drinking
Detailed description
Parent and peer interventions to reduce student drinking:
Efficacy;
Mediation:
Moderation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| parent handbook | Experimental | Behavioral: Parent Handbook and Peer Basicsparent handbook |
| peer basics | Experimental | Behavioral: Parent Handbook and Peer Basicspeer delivered basics |
| parent handbook and peer basics | Experimental | Behavioral: Parent Handbook and Peer Basicsparent handbook and peer basics |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- varsity athlete in high school
Key exclusion criteria (1 listed)
- not a varsity athlete in high school
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 |
|---|---|---|
| Parent Handbook and Peer BasicsAlso: Parent Handbook, Peer Delivered BASICSParent and Peer delivered interventions | Behavioural | parent handbook, parent handbook and peer basics, peer basics |
Primary outcome
heavy episodic drinking
Time frame: 6 months post baseline
typical daily drinking
heavy episodic drinking
Time frame: 9 months post baseline
typical daily drinking
heavy episodic peak drinking
Time frame: 6 months post baseline
peak number of drinks in one night
heavy episodic peak drinking
Time frame: 9 months post baseline
peak number of drinks in one night
1 secondary outcome
drinking consequences
Time frame: 9 months post baseline
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 16 Mar 2021.
- Results publication: PubMed 19515296Turrisi R, Larimer ME, Mallett KA, Kilmer JR, Ray AE, Mastroleo NR, Geisner IM, Grossbard J, Tollison S, Lostutter TW, Montoya H. A randomized clinical trial evaluating a combined alcohol intervention for high-risk college students. J Stud Alcohol Drugs. 2009 Jul;70(4):555-67. doi: 10.15288/jsad.2009.70.555.
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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.
Robert Turrisi, Ph.D. principal investigator
Penn State 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 Parent Handbook and Peer Basics in people with Alcohol Consumption, run by Penn State 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 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 16 Mar 2021. 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?
heavy episodic drinking (time frame: 6 months post baseline). 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?
On the ClinicalTrials.gov record for NCT01126164, which also lists 1 linked publication.
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 16 Mar 2021.