Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00292240 |
Other study ID # |
R21DA018854 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2004 |
Est. completion date |
April 2007 |
Study information
Verified date |
April 2024 |
Source |
RAND |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Over the past decade, many new programs intended to prevent substance use among adolescents
have been developed and evaluated. There has been a recent shift towards brief interventions
for youth in school (Brown, 2001; D'Amico and Fromme, 2002) and health care settings, such as
emergency rooms and inpatient clinics (Barnett et al., 2001; Colby et al., 1998; Monti et
al., 1999). Although the primary care setting presents a unique opportunity to intervene with
youth concerning drug use, such as marijuana or inhalants, many youth are not screened for
use (Friedman et al., 1990; Johnson and Millstein, 2003; Middleman et al., 1995) and
preventive services in this setting are significantly below recommended levels
(Halpern-Felsher et al., 2000; Klein et al., 2001; Ozer et al., 2001). The objectives of the
proposed research are to: 1) explore the feasibility of adapting a brief intervention from
our previous work for use in the primary care (PC) setting, and 2) assess the short-term
efficacy of the intervention in the PC setting. During year 1, focus groups of high-risk
youth (n=16), parents (n=8), and providers (n=8) will provide feedback on barriers to
implementing a substance use brief intervention in a PC setting. We define high-risk youth as
those who may have already developed regular patterns of use or have experienced some
problems due to their use. In addition, the intervention will be pilot tested with 10
high-risk youth who will provide feedback on intervention content. Revisions will be made to
the intervention curriculum based on this feedback and in year 2, the short-term efficacy of
the intervention will be tested with a small sample of high-risk youth (n=30). This study
will extend brief intervention research for youth, as it will be one of the first to examine
the feasibility of implementing a brief substance use intervention to PC with high-risk youth
and to determine the impact of this intervention on short-term outcomes.
Description:
Over the past decade, many new programs intended to motivate adolescents to decrease
substance use have been developed and evaluated. There has been a recent shift towards brief
interventions for youth in school (Brown, 2001; D'Amico and Fromme, 2002) and health care
settings, such as emergency rooms and inpatient clinics (Barnett et al., 2001; Colby et al.,
1998; Monti et al., 1999). Many youth who use drugs and alcohol are at risk for consequences
(Johnston et al., 2003). The primary care setting presents a unique opportunity to intervene
with substance abusing adolescents as 70% of youth age 10-18 visit a physician approximately
3 times a year (Gans and Newacheck, 1991; Monheit and Cunningham, 1992). However, many youth
are not screened for use in this setting (Friedman et al., 1990; Johnson and Millstein, 2003;
Middleman et al., 1995) and preventive services are significantly below recommended levels
(Halpern-Felsher et al., 2000; Klein et al., 2001; Ozer et al., 2001). This may be due to
clinician time constraints and insufficient training on substance abuse, adolescent fear that
parents may see the record, and clinician discomfort in asking questions about substance use
(Blum, 1987; Blum et al., 1996; Lustig et al., 2001; Marcell et al., 2002; Middleman et al.,
1995).
The present proposal is designed to meet the objectives of the Exploratory/Developmental
Grants program (R21) for studies that will contribute to the development of future, more
intensive and larger research programs. The objectives of the proposed research are to: 1)
explore the feasibility of adapting a brief intervention from our previous work in schools
and emergency rooms for use in the primary care setting, and 2) assess the short-term
efficacy of the intervention in the primary care setting. This project serves as our first
step in an innovative line of research designed to examine the viability of utilizing brief
interventions targeting adolescent drug use in primary care settings. Our objectives will be
accomplished through the following aims:
1. Explore the feasibility of adapting a brief intervention for high-risk youth in a
primary care (PC) setting. We will determine barriers and facilitative factors
associated with implementing a brief intervention in a PC setting through focus groups
with high-risk youth (n=16), parents (n=8), and clinicians (n=8). Intervention content
will be established through modifications of our previous brief intervention work in
school and hospital settings and from focus group feedback from adolescents, clinicians,
and parents. We anticipate the intervention will take 15 minutes and will be implemented
by a clinician (e.g., nurse) in the PC setting. The intervention will emphasize
motivational techniques and will address a variety of substances, including marijuana,
inhalants, alcohol, and cigarettes. We will pilot test the intervention with a small
sample of high-risk youth (n=10) to obtain feedback to discern whether the intervention
was difficult to implement (e.g., time constraints, comfort level) and how youth felt
about receiving feedback from their clinicians on their substance use (e.g., was it
helpful? What other topics would they have liked to discuss?). We will modify content
based on this feedback.
2. Implement and assess short-term efficacy of a brief intervention for high-risk youth in
a PC setting. We will implement the intervention in the PC setting with a small sample
of high-risk youth (n=30) and assess its potential impact on short-term outcomes (e.g.,
perceived prevalence of peer use, self-change efforts) at a 3-month follow up. These
youth will be compared to an assessment only control group (n=30).
This research will culminate with the development of a longer-term plan for implementing and
evaluating the intervention more intensively with a larger sample. Products will include: 1)
intervention materials adapted for use with high-risk youth in primary care settings, 2)
pilot data on intervention feasibility and implementation, and 3) an R01 application to
examine the generalizability and long-term impact of the intervention.