Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229983
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2005-09-29
Brief Title:
Medical Office Intervention for Adolescent Drug Use
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Medical Office Intervention for Adolescent Drug Use
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to assess the efficacy of a new intervention based on motivational enhancement therapy among adolescents with a history of substance use
Detailed Description:
In many parts of the US adolescent substance abuse treatment is scarce Several studies have shown that brief interventions increase the likelihood of patients completion of referrals to alcohol counseling or treatment Other studies have shown a direct effect of brief interventions on patients alcohol consumption Although brief interventions have been widely recommended for adolescents fewer studies have been conducted in this age group If the current study confirms the effectiveness of the Motivational Enhancement Therapy approach this will add another outpatient treatment option for adolescent patients with drug problems
The specific aims of the project are to
1 Test the effect of the brief intervention on drug use We hypothesize that among 12-18 year old medical patients who use drugs the experimental intervention two 60-minute motivational interviewing sessions administered by a trained clinician will be at least 25 more effective than standard care assessmentreferral only in decreasing drug use as measured by a 90-day Timeline Followback 6 TLFB calendar
2 Test the effect of the brief intervention in increasing engagement in substance abuse treatment We hypothesize that among 12-18 year old patients who are referred to drug counseling or other treatments the experimental intervention administered by a trained clinician will result in at least 25 more patients entering treatment compared to standard care as measured by the numbers of patients who complete referrals to treatment providers
3 Test the effect of the intervention on other substance-related outcomes We hypothesize that the intervention will result in similar reductions in alcohol use as measured by the TLFB and in drivingriding while impaired DRWI risks as measured by the score of a 4-item self-reported scale Other outcomes of interest include readiness to change school performance and experience of other harmful consequences of substance use and associated risk behaviors
4 Identify factors that moderate andor mediate the effect of the experimental intervention on our outcomes of interest drug use engagement in treatment and estimate their effect sizes Identifying moderating variables will help us to identify subgroups of optimal responders to the brief intervention Based on our previous experience we theorize that girls may respond more strongly to the intervention than boys and that those who participate in other treatments outpatient counseling andor a laboratory drug testing program will also have greater response
The specific aims of the project are to
1 Test the effect of the brief intervention on drug use We hypothesize that among 12-18 year old medical patients who use drugs the experimental intervention two 60-minute motivational interviewing sessions administered by a trained clinician will be at least 25 more effective than standard care assessmentreferral only in decreasing drug use as measured by a 90-day Timeline Followback 6 TLFB calendar
2 Test the effect of the brief intervention in increasing engagement in substance abuse treatment We hypothesize that among 12-18 year old patients who are referred to drug counseling or other treatments the experimental intervention administered by a trained clinician will result in at least 25 more patients entering treatment compared to standard care as measured by the numbers of patients who complete referrals to treatment providers
3 Test the effect of the intervention on other substance-related outcomes We hypothesize that the intervention will result in similar reductions in alcohol use as measured by the TLFB and in drivingriding while impaired DRWI risks as measured by the score of a 4-item self-reported scale Other outcomes of interest include readiness to change school performance and experience of other harmful consequences of substance use and associated risk behaviors
4 Identify factors that moderate andor mediate the effect of the experimental intervention on our outcomes of interest drug use engagement in treatment and estimate their effect sizes Identifying moderating variables will help us to identify subgroups of optimal responders to the brief intervention Based on our previous experience we theorize that girls may respond more strongly to the intervention than boys and that those who participate in other treatments outpatient counseling andor a laboratory drug testing program will also have greater response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None