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Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings

Primary Purpose

Substance Abuse

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
computer-assisted Screening & Brief Advice
computer-assisted Screening & Brief Advice Plus
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Adolescents, Screening, Advice, Referral

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Treatment Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Treatment as Usual

computer Screening & Brief Advice

computer Screening & Brief Advice Plus

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduced substance use

Secondary Outcome Measures

Initiation of substance use

Full Information

First Posted
January 27, 2012
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01523444
Brief Title
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
Official Title
Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study not funded.
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
Adolescents, Screening, Advice, Referral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Title
computer Screening & Brief Advice
Arm Type
Active Comparator
Arm Description
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.
Arm Title
computer Screening & Brief Advice Plus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
computer-assisted Screening & Brief Advice
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
computer-assisted Screening & Brief Advice Plus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduced substance use
Time Frame
3 and 12 months
Secondary Outcome Measure Information:
Title
Initiation of substance use
Time Frame
3 and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Mericle, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Treatment Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States

12. IPD Sharing Statement

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Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings

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