ClinicalTrials.gov
ClinicalTrials.gov Menu

PARTNER Recruitment and Brief Intervention Pilot Study (PARTNER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00735956
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : August 23, 2010
Sponsor:
Information provided by:
Duke University

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.


Condition or disease Intervention/treatment Phase
Alcohol Abuse Behavioral: Counseling Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PARTNER: The Underage Drinking: Building Health Care System Research
Study Start Date : September 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : August 2009

Intervention Details:
    Behavioral: Counseling
    Handouts, referrals and brief counseling sessions are given after determination of early alcohol abuse has been assessed.
    Other Names:
    • CRAFFT
    • Other Shared Items Proposal


Primary Outcome Measures :
  1. 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 Measures :
  1. Assessments and early intervention of identifying alcohol abuse in minors. [ Time Frame: Same day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Ages 12 through 20.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735956


Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Robert L Hubbard, PhD Duke University

Responsible Party: Robert L Hubbard, Ph.D., Duke University / NDRI
ClinicalTrials.gov Identifier: NCT00735956     History of Changes
Other Study ID Numbers: Pro00006998
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: August 23, 2010
Last Verified: August 2010

Keywords provided by Duke University:
Screening
Brief Intervention

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders