AzTrials
AzTrials

Alcohol or Other Drugs UsePhase 1/2NCT01464554

Brief Substance Use Intervention for Youth in Teen Court

A Phase 1/2 study testing Project Free Talk in people with Alcohol or Other Drugs Use, run by RAND at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Youth involved in the juvenile justice system have multiple problems, including an earlier onset of alcohol and drug use and higher rates of alcohol and drug use than their peers in the general population. Read more about this study

Who is it for?
Ages 14 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol or Other Drugs Use
What is being tested?
Project Free Talk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
193 participants
Where
1 siteUnited States
Study dates
Jan 2009to Aug 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 14-18 years old;
  • English speaking

Who cannot join

  • has medical marijuana card;
  • is older or younger than 14-18 years old,
  • does not speak English

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Council on Drug and Alcohol Abuse

    Santa Barbara, California, 93101

Other trials in United States

About this study

Youth involved in the juvenile justice system have multiple problems, including an earlier onset of alcohol and drug use and higher rates of alcohol and drug use than their peers in the general population. This 4.5 year study will develop and evaluate a new group intervention for youth who have committed a first time alcohol or drug offense. Teens will be randomized to receive either usual care or the new group intervention. Teens will complete a baseline, post-test (when they complete the intervention, which could vary for each teen but is typically around 6-8 weeks), and a 3-month follow-up survey upon completion of the intervention. The investigators will examine outcomes for a variety of behaviors, including alcohol and drug use and assess whether there are differences between the teens who received usual care and the teens who received the new group intervention.

Read the detailed description

It is well known that youth involved in the juvenile justice system have multiple problems, including an earlier onset of alcohol and drug use and higher rates of alcohol and drug use than their peers in the general population. Several recent innovative treatment approaches have been developed to address substance use and the multiple problems that these at-risk youth experience. What is less well documented, however, are innovative approaches to treat youth who are first time alcohol or drug offenders and who may just be beginning to experience problems due to their substance use. The investigators propose a 4.5 year study to adapt and test an efficacious group intervention among teens who have committed a first time alcohol or other drug misdemeanor offense. These teens have been referred by the juvenile Probation Department to a Teen Court program because they have not been found to need more serious intervention such as treatment or detention. The objectives of the proposed research are to: Aim 1. Design a developmentally sensitive intervention curriculum in which the investigators (a) utilize our previous work and components from relevant existing approaches targeting at-risk adolescents, (b) establish participant acceptance, and (c) establish feasibility of intervention delivery with the participants, providers and the proposed setting; Aim 2. Implement a pilot test of the revised intervention with an adolescent population of first time offenders in which the investigators (a) demonstrate our ability to retain sufficient numbers of this population; (b) ensure intervention fidelity throughout the course of the study and (c) evaluate participant satisfaction, group engagement, and group climate; Aim 3. Examine the impact of the intervention on cognitive and behavioral outcomes to determine (a) whether clinically significant changes in expectancies, perceived prevalence of peer use, self-change efforts, alcohol consumption, marijuana and other drug use, and related consequences occur; (b) if reductions occur, estimate the likely effect sizes, and (c) explore the mechanism of change for decreases in substance use and consequences through mediation analyses. Our study seeks to narrow the gap between research and practice and builds upon recommendations by NIDA's Blue Ribbon Task Force by conducting research in a nonacademic setting with a population at high risk for alcohol and drug abuse. This study will extend selective intervention research for at-risk youth, as it will be one of the first to examine the impact of a theoretically based selective intervention for first time juvenile Alcohol or Other Drug (AOD) offenders.

Being tested
Usual care, Project Free Talk
Keywords
adolescents, alcohol, drugs, delinquency, intervention
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual careBehavioural

    Also called ADAG

    alcohol and drug education

  • Project Free TalkBehavioural

    motivational interviewing alcohol and drug program

Study groups in NCT01464554
Study groupRoleWhat they receive
Usual CareActive comparatorTeens will receive six sessions of an alcohol and drug education group
Receives: Behavioral: Usual care
Project Free TalkExperimentalTeens will receive six sessions of and evidenced based motivational interviewing alcohol and drug program
Receives: Behavioral: Project Free Talk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. frequency of alcohol and drug use

    this will include the frequency of drinking and the frequency of marijuana use

    Measured: three month follow up

Secondary outcomes (1)
  1. frequency of other risk behaviors

    this will include sexual behavior and delinquent behavior

    Measured: 3 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2011 (estimated)
  2. Study startJan 2009
  3. Primary completionNov 2011
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01464554
Sponsor's protocol ID
R01DA019938-01
Status last verified
May 2015
First submitted
20 Jul 2011
Last updated
8 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Project Free Talk in people with Alcohol or Other Drugs Use, run by RAND at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

frequency of alcohol and drug use (time frame: three month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in