NCT01751672

Brief Summary

The purposes of this study are to: 1) implement a high fidelity Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol with computerized screening technology into three primary care clinics in urban Philadelphia; 2) conduct a randomized controlled trial to determine if an expanded SBIRT (SBIRT+) will help patients attend more specialty substance abuse treatment sessions and reduce substance use compared to SBIRT; 3) conduct a process evaluation of SBIRT+ at the three collaborating clinics consisting of focus groups and structured interviews to assess implementation barriers and workforce attitudinal shifts; and 4) provide an excellent clinical research training environment for undergraduate and graduate students from Lincoln University.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

December 5, 2012

Last Update Submit

March 27, 2023

Conditions

Keywords

SBIRTSubstance UseScreeningBrief InterventionPrimary Care

Outcome Measures

Primary Outcomes (1)

  • Change in Treatment Session Attendance from Baseline

    Treatment sessions attended for alcohol or drug use issues over time.

    0, 3, 6, 9, 12 months

Secondary Outcomes (2)

  • Change in Urinalysis from Baseline

    0, 3, 6, 9, 12 months

  • Change in Cost-Effectiveness from Baseline

    0, 3, 6, 9, 12 months

Study Arms (2)

SBIRT

ACTIVE COMPARATOR

Screening, Brief Intervention, and Referral to Treatment

Behavioral: SBIRT

SBIRT+

EXPERIMENTAL

Expanded Screening, Brief Intervention, and Referral to Treatment

Behavioral: SBIRT+

Interventions

SBIRT+BEHAVIORAL

Expanded Screening, Brief Intervention, and Referral to Treatment. One Standard SBIRT session, plus 2-6 additional Brief Intervention sessions as needed.

SBIRT+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient is 18 years or older
  • Alcohol and/or Drug screening score that indicates at least mild problem severity.

You may not qualify if:

  • medical or psychiatric complications
  • substance use is mild enough that further intervention is not warranted
  • patient reports plans to leave the area within the next 12 months
  • patient is unable to provide valid informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Eleventh Street Family Health Services of Drexel University

Philadelphia, Pennsylvania, 19123, United States

Location

Public Health Management Corporation's Care Clinic

Philadelphia, Pennsylvania, 19123, United States

Location

Abbottsford-Falls Family Practice, Resources for Human Development, Inc.

Philadelphia, Pennsylvania, 19144, United States

Location

Related Publications (1)

  • Chambers JE, Brooks AC, Medvin R, Metzger DS, Lauby J, Carpenedo CM, Favor KE, Kirby KC. Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial. Addict Sci Clin Pract. 2016 Apr 18;11(1):8. doi: 10.1186/s13722-016-0057-6.

MeSH Terms

Conditions

Alcohol DrinkingSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Adam C Brooks, PhD

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2012

First Posted

December 18, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations