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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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00292240
Study type Interventional
Source RAND
Contact
Status Completed
Phase N/A
Start date October 2004
Completion date April 2007

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