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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Alcohol or Other Drugs Use
- 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 group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Teens will receive six sessions of an alcohol and drug education group Receives: Behavioral: Usual care |
| Project Free Talk | Experimental | Teens 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.
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)
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.
- First posted3 Nov 2011 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol or Other Drugs UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth J. D'Amico, Ph.D., Principal investigator, RAND
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Substance Use Intervention for Youth in Teen Court
- ClinicalTrials.gov ID
- NCT01464554
- Acronym / sponsor ID
- R01DA019938-01
- Conditions
- Alcohol or Other Drugs Use
- Keywords
- adolescents, alcohol, drugs, delinquency, intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual careTeens will receive six sessions of an alcohol and drug education group |
| Project Free Talk | Experimental | Behavioral: Project Free TalkTeens will receive six sessions of and evidenced based motivational interviewing alcohol and drug program |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 14-18 years old;
- English speaking
Key exclusion criteria (3 listed)
- has medical marijuana card;
- is older or younger than 14-18 years old,
- does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careAlso: ADAGalcohol and drug education | Behavioural | Usual Care |
| Project Free Talkmotivational interviewing alcohol and drug program | Behavioural | Project Free Talk |
Primary outcome
frequency of alcohol and drug use
Time frame: three month follow up
this will include the frequency of drinking and the frequency of marijuana use
1 secondary outcome
frequency of other risk behaviors
Time frame: 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J. D'Amico, Ph.D. principal investigator
RAND
1 site in 1 country: see every site and its status.
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.