Alcohol Abuse Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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