Substance UseJDCNCT01668303
Family-Based Juvenile Drug Court Services
A study testing Miami Juvenile Drug Court-MDFT and Miami Juvenile Drug Court -TAU in people with Substance Use and Delinquency, run by University of Miami at 4 sites in United States.
Trial summary
The objective of the proposed study is to adapt and implement an efficacious adolescent substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug court service system. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Delinquency
- What is being tested?
- Miami Juvenile Drug Court-MDFT and Miami Juvenile Drug Court -TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2004to Nov 2009
- Phase
- Interventional
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Substance abuse or dependence disorder requiring outpatient treatment, and (b)after consulting with his or her attorney, the youth and family voluntarily agrees to enter juvenile drug court.
Who cannot join
- Their current offense is the sale of drugs, a gun offense, a violent offense, or sexual battery,(b) their current offense is likely to merit commitment to a secure or locked juvenile justice facility or (c) they have severe mental illness or retardation according to their intake MJDC evaluation.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Here's Help Inc.
Miami, Florida, 33054
Jackson Memorial Hospital
Miami, Florida, 33136
University of Miami Miller School of Medicine
Miami, Florida, 33136
Juvenile Drug Court
Miami, Florida, 33142
About this study
The objective of the proposed study is to adapt and implement an efficacious adolescent substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug court service system. Additionally, the investigators will also examine the extent to which MDFT can enhance the effectiveness of existing juvenile drug court services in terms of decreasing drug use, delinquent behavior and arrests and improving school and vocational outcomes. The study design is a fully randomized controlled trial.
Read the detailed description
Many questions remain regarding optimal treatments for juvenile drug court. To address this gap, the investigators will compare two treatments delivered in a drug court setting: Multidimensional Family Therapy (MDFT) and adolescent group therapy (AGT). This 5-year study will employ a fully randomized (2 conditions) by 5 assessment points (baseline, 6, 12, 18, and 24 months following baseline), repeated measures intent-to-treat design with multiple dependent variables. Adolescents who have been accepted into the Miami Juvenile Drug Court (MJDC) will be randomized to receive one of two treatments: MDFT (n = 57) or AGT (n = 55). The substance abuse treatments will be equivalent in terms of therapeutic dosage, and all youth with receive the same drug court program with wtreatment received being the only difference (family vs non-family treatment). In order to maximize the ecological validity of the study, both treatments will be delivered by community-based drug abuse counselors. MDFT will be delivered by providers at Jackson Memorial Hospital's Adolescent Substance Abuse Program and AGT by providers at a separate facility, Here's Help.
Aim 1. Acceptability and Effectiveness. The study will address the comparative acceptability and effectiveness of the two drug court programs in ways that are consistent with recommendations from the juvenile drug court literature to consider multi-domain and multiple perspectives of program goals and outcomes. First, effectiveness will be assessed in terms of the differential rates at which youth in MDFT and AGT graduate from drug court, a primary goal of the drug court program. Juvenile offending substance abusers and their families are notoriously difficult to engage and retain in any type of treatment program, yet family-based interventions have demonstrated impressive retention rates with these populations. Thus an important aspect of the proposed effectiveness evaluation will be the extent to which the MDFT intervention improves drug court program completion rates. Our second perspective on effectiveness involves an examination of the rates of change in a number of critical domains, including reductions in substance use, arrests, and delinquent behaviors, as well as improvements in school/vocational performance over a 2-year period. With these multidimensional outcome assessments the investigators will be able to explore different dimensions and trajectories of recovery following drug court participation. This is consistent with the aims of juvenile drug courts not only to reduce drug use and delinquency but also to increase adolescents' prosocial skills and behaviors. The investigators are also interested in examining multiple perspectives on the relative acceptability of MDFT to drug court staff, teens, and families, as recommended by drug court researchers.
Aim 2. Drug Court Program Mechanisms. While the few existing studies of key drug court factors have focused mainly on the structural and judicial aspects of drug court programs, almost nothing is known about the treatment processes affecting drug court outcomes, or the mechanisms of clinical and judicial component impact. Clearly, an important next step in this specialty is to delineate the treatment processes and ingredients that maximize outcomes in drug court, particularly in relation to the application of evidence-based therapy models within drug court programs. Examination of change mechanisms is now recognized as an essential feature of state-of-the-art drug abuse intervention research. Among those process variables considered important in mediating drug treatment outcomes are the therapeutic alliance that is formed between provider and client , and the extent to which a positive collaborative relationship develops among all drug court team members, including the judge. Research on family-based interventions supports the contention that family-based treatments exert their effects through the reduction of family risk and the facilitation of protective processes, and family functioning has been found to play a primary role in helping teens achieve and maintain recovery after substance abuse treatment. In sum, given that the quest to improve drug court program development, implementation, and outcomes rests in large part on the clarification of the programs' mechanisms of action, drug court researchers have turned their attention to analyses linking within-program processes to outcomes. The proposed study will do likewise.
- Conditions
- Substance Use, Delinquency
- Being tested
- Miami Juvenile Drug Court-MDFT, Miami Juvenile Drug Court -TAU
- Keywords
- juvenile drug court, adolescents, substance abuse, delinquency, family therapy, multidimensional family therapy
- 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.
Miami Juvenile Drug Court-MDFTBehavioural
MDFT assesses and intervenes in five domains: 1) Interventions with the adolescent, 2) interventions with the parent, 3) interventions to improve the parent-adolescent relationship, 4) interventions with other family members, and 5) interventions with external systems.
Miami Juvenile Drug Court -TAUBehavioural
Each client is provided with a primary outpatient counselor who develops a treatment plan to address long-range goals. Family members are included in an assessment and treatment planning session at the beginning of treatment, but no formal family therapy is provided. Group therapy topics include self-esteem enhancement, decision-making skills, stress/anger management, communication skills, health education, teen pregnancy prevention, and occupational/career planning.
| Study group | Role | What they receive |
|---|---|---|
| Miami Juvenile Drug Court-MDFT | Experimental | Multidimensional family therapy (MDFT) is primarily a family-based approach (Liddle, 2002)which conducts individual sessions with the teen and parent[s] but not peer-group sessions. Receives: Behavioral: Miami Juvenile Drug Court-MDFT |
| Miami Juvenile Drug Court -TAU | Other | The Treatment as Usual (TAU) condition is primarily a peer group-based and individual approach that uses cognitive-behavioral principles and interventions. Receives: Behavioral: Miami Juvenile Drug Court -TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graduation from juvenile drug court
Status of drug court graduation (graduated from drug court or did not graduate from drug court)
Measured: Collected once at 12 months from intake/baseline.
Change in substance use
Personal Experiences with Chemicals Inventory
Measured: Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline
Change in delinquency
Self-report, parent report, and juvenile justice records: Self-report delinquency scale, Youth Self Report, Child Behavior Checklist; arrests and disposition from juvenile justice records.
Measured: Baseline, and then at 6, 12, 18, and 24 months after baseline
Change in Mental health symptoms
Youth and parent report: Child Behavior Checklist, Youth Self Report
Measured: Baseline, 6, 12, 18 and 24 months after baseline
Change in Family functioning
Youth and Parent Report: Family Environment Scales, Parental Stress Index, Behavior Affect Relationship Scales
Measured: Baseline, 6, 14, 18, and 24 months after baseline
Length of treatment
How many weeks of treatment received
Measured: Collected once, at 12 months after baseline
Change in arrests
Arrests will be extracted from juvenile justice records.
Measured: 12 months before intake through 24 months after intake
Change in substance use
Measured by the Timeline Follow Back Method
Measured: Intake, 6, 12, 18, 24 months after intake
Change in substance use
Urinanalysis to detect drugs
Measured: Intake, 6, 12, 18 and 24 months after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startJun 2004
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gayle Dakof, University of Miami
- Investigators
- Gayle A. Dakof, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668303
- Sponsor's protocol ID
- R01DA017478
- Acronym
- JDC
- Status last verified
- Aug 2012
- First submitted
- 6 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dakof GA, Henderson CE, Rowe CL, Boustani M, Greenbaum PE, Wang W, Hawes S, Linares C, Liddle HA. A randomized clinical trial of family therapy in juvenile drug court. J Fam Psychol. 2015 Apr;29(2):232-41. doi: 10.1037/fam0000053. Epub 2015 Jan 26.
PubMed 25621927
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Juvenile Drug Court Services
- ClinicalTrials.gov ID
- NCT01668303
- Acronym / sponsor ID
- JDC / R01DA017478
- Conditions
- Substance Use, Delinquency
- Keywords
- juvenile drug court, adolescents, substance abuse, delinquency, family therapy, multidimensional family therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Aug 2012 (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.
The objective of the proposed study is to adapt and implement an efficacious adolescent substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug court service system. Additionally, the investigators will also examine the extent to which MDFT can enhance the effectiveness of existing juvenile drug court services in terms of decreasing drug use, delinquent behavior and arrests and improving school and vocational outcomes. The study design is a fully randomized controlled trial.
Detailed description
Many questions remain regarding optimal treatments for juvenile drug court. To address this gap, the investigators will compare two treatments delivered in a drug court setting: Multidimensional Family Therapy (MDFT) and adolescent group therapy (AGT). This 5-year study will employ a fully randomized (2 conditions) by 5 assessment points (baseline, 6, 12, 18, and 24 months following baseline), repeated measures intent-to-treat design with multiple dependent variables. Adolescents who have been accepted into the Miami Juvenile Drug Court (MJDC) will be randomized to receive one of two treatments: MDFT (n = 57) or AGT (n = 55). The substance abuse treatments will be equivalent in terms of therapeutic dosage, and all youth with receive the same drug court program with wtreatment received being the only difference (family vs non-family treatment). In order to maximize the ecological validity of the study, both treatments will be delivered by community-based drug abuse counselors. MDFT will be delivered by providers at Jackson Memorial Hospital's Adolescent Substance Abuse Program and AGT by providers at a separate facility, Here's Help.
Aim 1. Acceptability and Effectiveness. The study will address the comparative acceptability and effectiveness of the two drug court programs in ways that are consistent with recommendations from the juvenile drug court literature to consider multi-domain and multiple perspectives of program goals and outcomes. First, effectiveness will be assessed in terms of the differential rates at which youth in MDFT and AGT graduate from drug court, a primary goal of the drug court program. Juvenile offending substance abusers and their families are notoriously difficult to engage and retain in any type of treatment program, yet family-based interventions have demonstrated impressive retention rates with these populations. Thus an important aspect of the proposed effectiveness evaluation will be the extent to which the MDFT intervention improves drug court program completion rates. Our second perspective on effectiveness involves an examination of the rates of change in a number of critical domains, including reductions in substance use, arrests, and delinquent behaviors, as well as improvements in school/vocational performance over a 2-year period. With these multidimensional outcome assessments the investigators will be able to explore different dimensions and trajectories of recovery following drug court participation. This is consistent with the aims of juvenile drug courts not only to reduce drug use and delinquency but also to increase adolescents' prosocial skills and behaviors. The investigators are also interested in examining multiple perspectives on the relative acceptability of MDFT to drug court staff, teens, and families, as recommended by drug court researchers.
Aim 2. Drug Court Program Mechanisms. While the few existing studies of key drug court factors have focused mainly on the structural and judicial aspects of drug court programs, almost nothing is known about the treatment processes affecting drug court outcomes, or the mechanisms of clinical and judicial component impact. Clearly, an important next step in this specialty is to delineate the treatment processes and ingredients that maximize outcomes in drug court, particularly in relation to the application of evidence-based therapy models within drug court programs. Examination of change mechanisms is now recognized as an essential feature of state-of-the-art drug abuse intervention research. Among those process variables considered important in mediating drug treatment outcomes are the therapeutic alliance that is formed between provider and client , and the extent to which a positive collaborative relationship develops among all drug court team members, including the judge. Research on family-based interventions supports the contention that family-based treatments exert their effects through the reduction of family risk and the facilitation of protective processes, and family functioning has been found to play a primary role in helping teens achieve and maintain recovery after substance abuse treatment. In sum, given that the quest to improve drug court program development, implementation, and outcomes rests in large part on the clarification of the programs' mechanisms of action, drug court researchers have turned their attention to analyses linking within-program processes to outcomes. The proposed study will do likewise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miami Juvenile Drug Court-MDFT | Experimental | Behavioral: Miami Juvenile Drug Court-MDFTMultidimensional family therapy (MDFT) is primarily a family-based approach (Liddle, 2002)which conducts individual sessions with the teen and parent[s] but not peer-group sessions. |
| Miami Juvenile Drug Court -TAU | Other | Behavioral: Miami Juvenile Drug Court -TAUThe Treatment as Usual (TAU) condition is primarily a peer group-based and individual approach that uses cognitive-behavioral principles and interventions. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Substance abuse or dependence disorder requiring outpatient treatment, and (b)after consulting with his or her attorney, the youth and family voluntarily agrees to enter juvenile drug court.
Key exclusion criteria (1 listed)
- Their current offense is the sale of drugs, a gun offense, a violent offense, or sexual battery,(b) their current offense is likely to merit commitment to a secure or locked juvenile justice facility or (c) they have severe mental illness or retardation according to their intake MJDC evaluation.
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 |
|---|---|---|
| Miami Juvenile Drug Court-MDFTMDFT assesses and intervenes in five domains: 1) Interventions with the adolescent, 2) interventions with the parent, 3) interventions to improve the parent-adolescent relationship, 4) interventions with other family members, and 5) interventions with external systems. | Behavioural | Miami Juvenile Drug Court-MDFT |
| Miami Juvenile Drug Court -TAUEach client is provided with a primary outpatient counselor who develops a treatment plan to address long-range goals. Family members are included in an assessment and treatment planning session at the beginning of treatment, but no formal family therapy is provided. Group therapy topics include self-esteem enhancement, decision-making skills, stress/anger management, communication skills, health education, teen pregnancy prevention, and occupational/career planning. | Behavioural | Miami Juvenile Drug Court -TAU |
Primary outcome
Graduation from juvenile drug court
Time frame: Collected once at 12 months from intake/baseline.
Status of drug court graduation (graduated from drug court or did not graduate from drug court)
Change in substance use
Time frame: Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline
Personal Experiences with Chemicals Inventory
Change in delinquency
Time frame: Baseline, and then at 6, 12, 18, and 24 months after baseline
Self-report, parent report, and juvenile justice records: Self-report delinquency scale, Youth Self Report, Child Behavior Checklist; arrests and disposition from juvenile justice records.
Change in Mental health symptoms
Time frame: Baseline, 6, 12, 18 and 24 months after baseline
Youth and parent report: Child Behavior Checklist, Youth Self Report
Change in Family functioning
Time frame: Baseline, 6, 14, 18, and 24 months after baseline
Youth and Parent Report: Family Environment Scales, Parental Stress Index, Behavior Affect Relationship Scales
Length of treatment
Time frame: Collected once, at 12 months after baseline
How many weeks of treatment received
Change in arrests
Time frame: 12 months before intake through 24 months after intake
Arrests will be extracted from juvenile justice records.
Change in substance use
Time frame: Intake, 6, 12, 18, 24 months after intake
Measured by the Timeline Follow Back Method
Change in substance use
Time frame: Intake, 6, 12, 18 and 24 months after intake
Urinanalysis to detect drugs
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 20 Aug 2012.
- Derived from this study: PubMed 25621927Dakof GA, Henderson CE, Rowe CL, Boustani M, Greenbaum PE, Wang W, Hawes S, Linares C, Liddle HA. A randomized clinical trial of family therapy in juvenile drug court. J Fam Psychol. 2015 Apr;29(2):232-41. doi: 10.1037/fam0000053. Epub 2015 Jan 26.
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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.
Gayle A. Dakof, Ph.D. principal investigator
University of Miami
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miami Juvenile Drug Court-MDFT and Miami Juvenile Drug Court -TAU in people with Substance Use and Delinquency, run by University of Miami at 4 sites 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 1 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 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Graduation from juvenile drug court (time frame: Collected once at 12 months from intake/baseline.). The study lists 9 primary outcomes in all. 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 NCT01668303, which also lists 1 linked publication.
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 20 Aug 2012.