- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01523444
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
March 27, 2023 updated by: Treatment Research Institute
This proposed study tests the effectiveness and examines the implementation of screening and brief intervention techniques to delay initiation and reduce substance use among adolescents accessing medical care in Federally Qualified Health Care settings with a computer-facilitated intervention.
The primary hypothesis is that participants in the intervention groups will be more likely to cease or reduce substance use at follow-up compared to clients in the treatment as usual condition.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
The aims of the proposed 5-year study are threefold: (1) To examine the effectiveness of a computer-facilitated Screening and Brief Advice (cSBA) to reduce initiation and substance abuse among adolescents in a novel setting; (2) To examine the comparative effectiveness of adding a Brief Intervention and Referral to Treatment component to the cSBA intervention among adolescents in these centers; (3) To examine factors facilitating and inhibiting the implementation of SBIRT-type procedures with adolescents in FQHCs.
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- Treatment Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 12-18 year old patients seeking care at the primary care participating sites
Exclusion Criteria:
- Unable to read and understand English
- Medically unstable
- Unavailable for follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as Usual
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|
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Active Comparator: computer Screening & Brief Advice
All participants receiving care at the site assigned to the computer-facilitated screening and brief advice (cSBA) condition will receive the cSBA intervention as part of their care at that clinic.
|
The computer-facilitated screening and brief advice (cSBA) intervention is a self-administered, computer-facilitated screening that asks about lifetime and past-12-month use of substances followed by scientific information about how substance use affects health and true-life stories illustrating the health risks of substance use.
The cSBA program prints out a Report Form with the screening results, risk level, and "talking points" designed to prompt a 2 to 3-minute provider/teen conversation about the health effects of substance use, which recommends abstinence.
|
|
Experimental: computer Screening & Brief Advice Plus
All participants receiving care at the site assigned to the cSBA+ condition will receive the cSBA intervention elements plus the delivery of a brief, two-session motivational enhancement therapy (MET) intervention to be delivered a Behavioral Health Counselor (BHC) at the clinic immediately after meeting with the primary care provider as part of care at that clinic.
|
The cSBA+ intervention contains cSBA intervention elements plus the delivery of a brief, two-session motivational enhancement therapy (MET) intervention to be delivered a Behavioral Health Counselor (BHC) at the clinic immediately after meeting with the primary care provider.
In the first session of this intervention, youth should be encouraged to think about: (1) The role alcohol and drugs play in his/her life; (2) His/her personal goals for changing alcohol and drug use; (3) Strategies for reaching and maintaining goals.
The goal at the end of the session is positive movement in the direction of abstinence or change.
The aim of the second session is reinforcement of goals set forth in the prior meeting with the BHC.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduced substance use
Time Frame: 3 and 12 months
|
3 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Initiation of substance use
Time Frame: 3 and 12 Months
|
3 and 12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy Mericle, Ph.D., Treatment Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Anticipated)
February 1, 2016
Study Completion (Anticipated)
November 1, 2017
Study Registration Dates
First Submitted
January 27, 2012
First Submitted That Met QC Criteria
January 27, 2012
First Posted (Estimate)
February 1, 2012
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASBIRT-PA-11-311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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