Alcohol ConsumptionACTNCT01126151
Parent Interventions to Prevent Student Drinking
A study testing parent handbook in people with Alcohol Consumption, run by Penn State University at 1 site in United States.
Trial summary
Examine the efficacy of parent interventions to prevent college student drinking in first year students. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Sep 2012
- 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
- first year students
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Examine the efficacy of parent interventions to prevent college student drinking in first year students.
Read the detailed description
The aims of the study are to:
- efficacy of parent interventions to prevent college student drinking in first year students;
- examine mediators of efficacy; and
- examine moderators of efficacy.
- Conditions
- Alcohol Consumption
- Being tested
- parent handbook
- Keywords
- drinking, alcohol consequences
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent handbookBehavioural
Also called Parent Communication Materials
parent handbook
| Study group | Role | What they receive |
|---|---|---|
| parent handbook | Experimental | parent handbook to increase the quantity and quality of communications about alcohol Receives: Behavioral: parent handbook |
| parent handbook with boosters | Experimental | boosters are given to parents at three times (move in, visit weekend; student visits home) Receives: Behavioral: parent handbook |
| parent handbook delay | Experimental | parent handbook is delayed and given after semester has begun Receives: Behavioral: parent handbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
heavy episodic drinking
frequency of heavy episodic events
Measured: 12 months post baseline
Secondary outcomes (1)
drinking related consequences
Assess blackouts, hangovers, vomiting, fights, unplanned sex, academic problems and trouble with the police using the RAPI; YAAPST (standard assessment instruments for college alcohol prevention trials)
Measured: 12 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 startJul 2006
- Primary completionOct 2010
- Study completionSep 2012
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.
- 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
- 1,900 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
- NCT01126151
- Sponsor's protocol ID
- R01AA015737
- Acronym
- ACT
- Status last verified
- Dec 2017
- First submitted
- 17 May 2010
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Interventions to Prevent Student Drinking
- ClinicalTrials.gov ID
- NCT01126151
- Acronym / sponsor ID
- ACT / R01AA015737
- Conditions
- Alcohol Consumption
- Keywords
- drinking, alcohol consequences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Sep 2012 (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.
Examine the efficacy of parent interventions to prevent college student drinking in first year students.
Detailed description
The aims of the study are to:
- efficacy of parent interventions to prevent college student drinking in first year students;
- examine mediators of efficacy; and
- examine moderators of efficacy.
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 handbookparent handbook to increase the quantity and quality of communications about alcohol |
| parent handbook with boosters | Experimental | Behavioral: parent handbookboosters are given to parents at three times (move in, visit weekend; student visits home) |
| parent handbook delay | Experimental | Behavioral: parent handbookparent handbook is delayed and given after semester has begun |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first year students
Key exclusion criteria (1 listed)
- none
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 handbookAlso: Parent Communication Materialsparent handbook | Behavioural | parent handbook, parent handbook delay, parent handbook with boosters |
Primary outcome
heavy episodic drinking
Time frame: 12 months post baseline
frequency of heavy episodic events
1 secondary outcome
drinking related consequences
Time frame: 12 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 15 Dec 2017.
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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 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 15 Dec 2017. 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: 12 months post baseline). 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 15 Dec 2017.