Alcohol AbusePhase 1/2PARTNERNCT00735956
PARTNER Recruitment and Brief Intervention Pilot Study
A Phase 1/2 study testing Counseling in people with Alcohol Abuse, run by Duke University at 1 site in United States.
Trial summary
Purpose of the study: This is a pilot randomized controlled trial to identify methods of involving underage youth in interventions to reduce alcohol use through the primary health care system. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2009
- Phase
- Phase 1/2
- 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 12 through 20.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PARTNER: The Underage Drinking: Building Health Care System Research
Purpose of the study:
This is a pilot randomized controlled trial to identify methods of involving underage youth in interventions to reduce alcohol use through the primary health care system. The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices.
Read the detailed description
There will be approximately 3-5 sites who will participate in this study. These sites may include two private practices in Roxboro and Creedmoor, North Carolina, the Duke Hospital and two practices in the Five County region of NC who are implementing Integrated, Collaborative, Accessible, Respectful, and Evidence-based (ICARE). In each clinic one day of the week (or 2 half days) will be chosen randomly from the days the clinic identifies as appropriate. During this time a behavioral health specialist (BHS) will be on site to recruit potential participants. All patients will be asked to speak to the specialist. On two other randomly selected days printed material will be given to all parents of underage patients and the underage patients. This material will describe the study and give the specialist's contact information. If the patients are 18 to 21 years old the material will be given directly to the patient.
The BHS will ask all interested participants to sign the informed consent/minor consent and one parent/legal guardian will be asked to counter sign the informed consent if subject is not 18 years of age yet. All participants signing informed consent will be given the CRAFFT and the PARTNER basic information questions in an interview with the specialist.
The primary outcome measure will be the number of participants recruited per day by the on site BHS versus appointment recruitment method. In addition, the total number of clinic visits for patients' ages 14 to 21 years old on each day of the week will be totaled by age, gender and ethnicity to determine the penetration rates for the recruitment procedures. And lastly, medical records at the treatment referral sites will be checked to identify the number of participants referred.
The study will recruit subjects at each site for approximately last six months.
- Conditions
- Alcohol Abuse
- Being tested
- Counseling
- Keywords
- Screening, Brief Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Also called CRAFFT, Other Shared Items Proposal
Handouts, referrals and brief counseling sessions are given after determination of early alcohol abuse has been assessed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices.
Measured: Same day
Secondary outcomes (1)
Assessments and early intervention of identifying alcohol abuse in minors.
Measured: Same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionAug 2009
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Investigators
- Robert L Hubbard, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735956
- Sponsor's protocol ID
- Pro00006998
- Acronym
- PARTNER
- Status last verified
- Aug 2010
- First submitted
- 13 Aug 2008
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARTNER: The Underage Drinking: Building Health Care System Research
- ClinicalTrials.gov ID
- NCT00735956
- Acronym / sponsor ID
- PARTNER / Pro00006998
- Conditions
- Alcohol Abuse
- Keywords
- Screening, Brief Intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Aug 2008 (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.
Purpose of the study:
This is a pilot randomized controlled trial to identify methods of involving underage youth in interventions to reduce alcohol use through the primary health care system. The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices.
Detailed description
There will be approximately 3-5 sites who will participate in this study. These sites may include two private practices in Roxboro and Creedmoor, North Carolina, the Duke Hospital and two practices in the Five County region of NC who are implementing Integrated, Collaborative, Accessible, Respectful, and Evidence-based (ICARE). In each clinic one day of the week (or 2 half days) will be chosen randomly from the days the clinic identifies as appropriate. During this time a behavioral health specialist (BHS) will be on site to recruit potential participants. All patients will be asked to speak to the specialist. On two other randomly selected days printed material will be given to all parents of underage patients and the underage patients. This material will describe the study and give the specialist's contact information. If the patients are 18 to 21 years old the material will be given directly to the patient.
The BHS will ask all interested participants to sign the informed consent/minor consent and one parent/legal guardian will be asked to counter sign the informed consent if subject is not 18 years of age yet. All participants signing informed consent will be given the CRAFFT and the PARTNER basic information questions in an interview with the specialist.
The primary outcome measure will be the number of participants recruited per day by the on site BHS versus appointment recruitment method. In addition, the total number of clinic visits for patients' ages 14 to 21 years old on each day of the week will be totaled by age, gender and ethnicity to determine the penetration rates for the recruitment procedures. And lastly, medical records at the treatment referral sites will be checked to identify the number of participants referred.
The study will recruit subjects at each site for approximately last six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Ages 12 through 20.
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 |
|---|---|---|
| CounselingAlso: CRAFFT, Other Shared Items ProposalHandouts, referrals and brief counseling sessions are given after determination of early alcohol abuse has been assessed. | Behavioural | – |
Primary outcome
The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices.
Time frame: Same day
1 secondary outcome
Assessments and early intervention of identifying alcohol abuse in minors.
Time frame: Same day
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 23 Aug 2010.
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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 L Hubbard, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Counseling in people with Alcohol Abuse, run by Duke 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 23 Aug 2010. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices. (time frame: Same day). 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 23 Aug 2010.