PARTNER Recruitment and Brief Intervention Pilot Study (PARTNER)
Primary Purpose
Alcohol Abuse
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Abuse focused on measuring Screening, Brief Intervention
Eligibility Criteria
Inclusion Criteria:
Ages 12 through 20.
Exclusion Criteria:
None
Sites / Locations
- Duke University
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assessments and early intervention of identifying alcohol abuse in minors.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00735956
Brief Title
PARTNER Recruitment and Brief Intervention Pilot Study
Acronym
PARTNER
Official Title
PARTNER: The Underage Drinking: Building Health Care System Research
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Screening, Brief Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Other Intervention Name(s)
CRAFFT, Other Shared Items Proposal
Intervention Description
Handouts, referrals and brief counseling sessions are given after determination of early alcohol abuse has been assessed.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Assessments and early intervention of identifying alcohol abuse in minors.
Time Frame
Same day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 12 through 20.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Hubbard, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PARTNER Recruitment and Brief Intervention Pilot Study
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