PARTNER Recruitment and Brief Intervention Pilot Study

This study has been completed.
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00735956
First received: August 13, 2008
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Alcohol Abuse
Behavioral: Counseling
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PARTNER: The Underage Drinking: Building Health Care System Research

Further study details as provided by Duke University:

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. [ Time Frame: Same day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessments and early intervention of identifying alcohol abuse in minors. [ Time Frame: Same day ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Ages 12 through 20.

Exclusion Criteria:

None

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Robert L Hubbard, Ph.D., Duke University / NDRI
ClinicalTrials.gov Identifier: NCT00735956     History of Changes
Other Study ID Numbers: Pro00006998
Study First Received: August 13, 2008
Last Updated: August 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Screening
Brief Intervention

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

ClinicalTrials.gov processed this record on August 27, 2014