NCT01523444

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

January 27, 2012

Last Update Submit

March 27, 2023

Conditions

Keywords

AdolescentsScreeningAdviceReferral

Outcome Measures

Primary Outcomes (1)

  • Reduced substance use

    3 and 12 months

Secondary Outcomes (1)

  • Initiation of substance use

    3 and 12 Months

Study Arms (3)

Treatment as Usual

NO INTERVENTION

computer Screening & Brief Advice

ACTIVE COMPARATOR

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.

Behavioral: computer-assisted Screening & Brief Advice

computer Screening & Brief Advice Plus

EXPERIMENTAL

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.

Behavioral: computer-assisted Screening & Brief Advice Plus

Interventions

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.

computer Screening & Brief Advice

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.

computer Screening & Brief Advice Plus

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • year old patients seeking care at the primary care participating sites

You may not qualify if:

  • Unable to read and understand English
  • Medically unstable
  • Unavailable for follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment Research Institute

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Amy Mericle, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2012

First Posted

February 1, 2012

Study Start

September 1, 2013

Primary Completion

February 1, 2016

Study Completion

November 1, 2017

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations