Adolescent Substance UsePhase 2NCT01266109
Enhancing Juvenile Drug Court Outcomes With Evidence-Based Practices
A Phase 2 study testing Contingency Management-Family Engagement (CM-FAM) and Usual Services (US) in people with Adolescent Substance Use, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Juvenile drug courts were developed in response to a perceived need to intervene more effectively with youth with substance abuse problems. Close collaboration between the court and substance abuse treatment provider is a defining component of the drug court model and is critical to helping youth achieve positive… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent Substance Use
- What is being tested?
- Contingency Management-Family Engagement (CM-FAM) and Usual Services (US)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2012
- Phase
- Phase 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Juvenile Drug Court-involved youth
- Fluency in English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Juvenile drug courts were developed in response to a perceived need to intervene more effectively with youth with substance abuse problems. Close collaboration between the court and substance abuse treatment provider is a defining component of the drug court model and is critical to helping youth achieve positive outcomes. Despite the proliferation of juvenile drug courts in recent years, however, evaluation of their capacity to reduce offender substance use and criminal activity has lagged. Moreover, the Institute of Medicine (IOM, 1998) and leading experts (McLellan, Carise, \& Kleber, 2003) have presented a bleak picture of the nation's capacity to meet the treatment needs of substance abusing individuals. Although community-based programs provide the backbone of substance abuse treatment in the nation, their capabilities have not kept up with major scientific advances in the development and validation of evidence-based substance abuse interventions.
Building on our research findings and experience regarding juvenile drug court outcomes as well as the transport of evidence-based practices to community treatment settings, the purpose of this study is to develop and test a relatively flexible and low cost strategy for enhancing the outcomes of juvenile drug courts by integrating components of evidence-based treatments into existing substance abuse services.
Read more
Specifically, this project aims to:
Aim 1: Adapt existing intervention and training protocols from evidence-based practices (i.e., Contingency Management for adolescent substance abuse; family engagement strategies from evidence-based treatments of juvenile offenders) for integration into juvenile drug court sites.
Aim 2: Conduct a study to examine youth (e.g., substance use and criminal behavior) and system level (e.g., intervention adherence, feasibility, retention and completion rates, consumer satisfaction, cost estimates) effects of implementing the intervention protocols in juvenile drug courts.
Aim 3: Revise the intervention and training protocols in preparation for a Stage II study if findings are supportive.
- Conditions
- Adolescent Substance Use
- Being tested
- Contingency Management-Family Engagement (CM-FAM), Usual Services (US)
- Keywords
- Substance Use, Delinquency, Juvenile Drug Court, Contingency Management, Family Engagement
- 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.
Contingency Management-Family Engagement (CM-FAM)Behavioural
Evidence-based outpatient intervention for adolescent substance use
Usual Services (US)Other
Typical community-based substance abuse treatment services
| Study group | Role | What they receive |
|---|---|---|
| CM-FAM | Experimental | Not described Receives: Behavioral: Contingency Management-Family Engagement (CM-FAM) |
| US | Active comparator | Not described Receives: Other: Usual Services (US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance Use
Measured: Quarterly for up to 1 year post-baseline
Secondary outcomes (4)
Delinquency
Measured: Quarterly for up to 1 year post-baseline
Intervention Fidelity
Measured: Monthly for up to 1 year post-baseline
Cost Estimates
Measured: Annually for 4 years
Consumer Satisfaction
Measured: Bi-annually for 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startSep 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adolescent Substance UseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Scott W Henggeler, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266109
- Sponsor's protocol ID
- 019892
- Other IDs
- R01DA019892
- Status last verified
- May 2013
- First submitted
- 18 Nov 2010
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tuerk EH, McCart MR, Henggeler SW. Collaboration in family therapy. J Clin Psychol. 2012 Feb;68(2):168-78. doi: 10.1002/jclp.21833.
PubMed 23616297Henggeler SW, McCart MR, Cunningham PB, Chapman JE. Enhancing the effectiveness of juvenile drug courts by integrating evidence-based practices. J Consult Clin Psychol. 2012 Apr;80(2):264-75. doi: 10.1037/a0027147. Epub 2012 Feb 6.
PubMed 22309470McCart MR, Henggeler SW, Chapman JE, Cunningham PB. System-level effects of integrating a promising treatment into juvenile drug courts. J Subst Abuse Treat. 2012 Sep;43(2):231-43. doi: 10.1016/j.jsat.2011.10.030. Epub 2011 Dec 5.
PubMed 22154039
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Juvenile Drug Court Outcomes With Evidence-Based Practices
- ClinicalTrials.gov ID
- NCT01266109
- Acronym / sponsor ID
- 019892
- Conditions
- Adolescent Substance Use
- Keywords
- Substance Use, Delinquency, Juvenile Drug Court, Contingency Management, Family Engagement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Dec 2010 (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.
Juvenile drug courts were developed in response to a perceived need to intervene more effectively with youth with substance abuse problems. Close collaboration between the court and substance abuse treatment provider is a defining component of the drug court model and is critical to helping youth achieve positive outcomes. Despite the proliferation of juvenile drug courts in recent years, however, evaluation of their capacity to reduce offender substance use and criminal activity has lagged. Moreover, the Institute of Medicine (IOM, 1998) and leading experts (McLellan, Carise, \& Kleber, 2003) have presented a bleak picture of the nation's capacity to meet the treatment needs of substance abusing individuals. Although community-based programs provide the backbone of substance abuse treatment in the nation, their capabilities have not kept up with major scientific advances in the development and validation of evidence-based substance abuse interventions.
Building on our research findings and experience regarding juvenile drug court outcomes as well as the transport of evidence-based practices to community treatment settings, the purpose of this study is to develop and test a relatively flexible and low cost strategy for enhancing the outcomes of juvenile drug courts by integrating components of evidence-based treatments into existing substance abuse services.
Specifically, this project aims to:
Aim 1: Adapt existing intervention and training protocols from evidence-based practices (i.e., Contingency Management for adolescent substance abuse; family engagement strategies from evidence-based treatments of juvenile offenders) for integration into juvenile drug court sites.
Aim 2: Conduct a study to examine youth (e.g., substance use and criminal behavior) and system level (e.g., intervention adherence, feasibility, retention and completion rates, consumer satisfaction, cost estimates) effects of implementing the intervention protocols in juvenile drug courts.
Aim 3: Revise the intervention and training protocols in preparation for a Stage II study if findings are supportive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM-FAM | Experimental | Behavioral: Contingency Management-Family Engagement (CM-FAM) |
| US | Active comparator | Other: Usual Services (US) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Juvenile Drug Court-involved youth
- Fluency in English
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Contingency Management-Family Engagement (CM-FAM)Evidence-based outpatient intervention for adolescent substance use | Behavioural | CM-FAM |
| Usual Services (US)Typical community-based substance abuse treatment services | Other | US |
Primary outcome
Substance Use
Time frame: Quarterly for up to 1 year post-baseline
4 secondary outcomes
Delinquency
Time frame: Quarterly for up to 1 year post-baseline
Intervention Fidelity
Time frame: Monthly for up to 1 year post-baseline
Cost Estimates
Time frame: Annually for 4 years
Consumer Satisfaction
Time frame: Bi-annually for 4 years
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 18 Jun 2013.
- Background: PubMed 23616297Tuerk EH, McCart MR, Henggeler SW. Collaboration in family therapy. J Clin Psychol. 2012 Feb;68(2):168-78. doi: 10.1002/jclp.21833.
- Results publication: PubMed 22309470Henggeler SW, McCart MR, Cunningham PB, Chapman JE. Enhancing the effectiveness of juvenile drug courts by integrating evidence-based practices. J Consult Clin Psychol. 2012 Apr;80(2):264-75. doi: 10.1037/a0027147. Epub 2012 Feb 6.
- Results publication: PubMed 22154039McCart MR, Henggeler SW, Chapman JE, Cunningham PB. System-level effects of integrating a promising treatment into juvenile drug courts. J Subst Abuse Treat. 2012 Sep;43(2):231-43. doi: 10.1016/j.jsat.2011.10.030. Epub 2011 Dec 5.
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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.
Scott W Henggeler, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contingency Management-Family Engagement (CM-FAM) and Usual Services (US) in people with Adolescent Substance Use, run by Medical University of South Carolina 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 1 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 18 Jun 2013. 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 phase mean?
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?
Substance Use (time frame: Quarterly for up to 1 year post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01266109, which also lists 3 linked publications.
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 18 Jun 2013.