Substance UseDTCNCT01910324
Juvenile Detention to Community Life
A study testing Multidimensional Family Therapy Cross-Systems and Enhanced Services as Usual in people with Substance Use and Delinquency, run by University of Miami at 5 sites in United States.
Trial summary
The fundamental objective of the proposed study is to develop and test an innovative two-stage, cross-systems family-based intervention for substance abusing juvenile offenders. The first stage of the experimental treatment is provided for youths in juvenile detention settings. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Delinquency, Risk for HIV Infection
- What is being tested?
- Multidimensional Family Therapy Cross-Systems and Enhanced Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2006to Dec 2011
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be between the ages of 13 and 17
- Be incarcerated in a juvenile detention facility at intake
- Endorse substance abuse problems on the MAYSI or other intake forms
- Have at least one parent figure willing/able to participate in the intervention and research assessments
- Provide informed consent to participate in the study
Who cannot join
- Mental retardation or pervasive developmental disorders
- Psychotic features
- Current suicidality defined as Ideation + Plan + High intention to carry out plan
- High risk to receive long-term residential placement directly from detention
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pinellas Juvenile Detention Center
Clearwater, Florida, 33760
Operation PAR Inc.
Largo, Florida, 33771
Here's Help, Inc.
Miami, Florida, 33054
University of Miami Miller School of Medicine
Miami, Florida, 33136
Miami-Dade Juvenile Detention Center
Miami, Florida, 33142
About this study
Official title: Facilitating Adolescent Offenders' Reintegration From Juvenile Detention to Community Life (DTC)
The fundamental objective of the proposed study is to develop and test an innovative two-stage, cross-systems family-based intervention for substance abusing juvenile offenders. The first stage of the experimental treatment is provided for youths in juvenile detention settings. Stage two of the intervention occurs after the offender is released to the community. Participants are randomized to one of two study conditions: the cross-systems family-based intervention (Multidimensional Family Therapy-Cross Systems (MDFT-CS), or 2) Enhanced Services as Usual (ESAU). Both conditions incorporate HIV prevention in detention and we will also examine the effects of a family-based HIV/STD prevention module beyond the impact of a standard HIV/STD education intervention delivered in detention by including ongoing HIV/STD intervention in MDFT-CS following release from detention. There are five aims of the proposed study. These aims relate to: 1) Intervention development and implementation; 2) Clinical effectiveness; 3) Impact of HIV/AIDS/STD prevention; 4) Comparative benefit-costs; and 5) Systems-level impact
Read the detailed description
This study will employ a fully randomized (2 conditions) by 9 assessment points (baseline, discharge from detention, and 3, 6, 9, 18, 24, 36 and 42 months following detention discharge), repeated measures intent-to-treat design with multiple dependent variables. 154 males and females (85 participants from Miami Dade Regional Juvenile Detention Center and 85 from Pinellas Juvenile Detention Center) who meet the study eligibility criteria will be randomized to one of the two treatment conditions.
The study will also include a 6-month pilot phase. During this phase, the MDFT detention intervention and cross-systems collaboration protocols will be developed; the existing treatment manual will be revised; the MDFT-CS with family-based HIV prevention module and standard HIV education intervention will be developed; family therapists will be trained in the MDFT intervention (including HIV/STD module); the MDFT-CS intervention will be piloted; the assessment battery will be piloted; the protocols, manual, and training package will be revised and finalized; research staff will be trained on all procedures and protocols; and data management procedures will be developed.
During Stage 1, adolescents in all intervention conditions will receive standard detention services, which include education and health care. In addition, youth assigned to the ESAU condition will receive the standard mental health and substance abuse services offered in the detention (mainly psychoeducational in nature). Youth assigned to the MDFT-CS intervention will not receive standard mental health/substance abuse services provided by the detention center, as these youth will be assigned a MDFT therapist who will address their mental health and substance abuse issues needs.
Experimental Treatment: Multidimensional Family Therapy-Cross Systems (MDFT-CS). In Stage 1 (in detention) MDFT-CS, the experimental treatment, consists of two major components: standard initial/engagement work with parents in the home and with adolescents in detention (both conducted weekly for the duration of the adolescents stay in detention), plus a state-of-the-art HIV education prevention module based on CDC-endorsed strategies. The in-detention MDFT will be delivered by therapists employed by the University of Miami/ Center for Treatment Research on Adolescent Drug Abuse (CTRADA) who will continue to treat the youth and family after release from detention. In Stage 2, the experimental treatment includes the standard MDFT components (4 overall change units/targets: adolescent, parent, family interaction, and functioning of the family members vis a vis relevant extrafamilial social systems such as school and juvenile justice).
Enhanced Services as Usual (ESAU). In Stage 1 (in detention), ESAU includes two major components - standard drug treatment services that are delivered by detention staff, and state-of-the-art HIV education prevention intervention delivered to all participating youth.
In Stage 2, community drug treatment providers deliver high quality drug treatment on an outpatient basis. To minimize heterogeneity within the comparison condition, and in order to provide better service and treatment tracking opportunities, the study will only use one community based treatment agency to deliver ESAU per locale at each Research Center.
All measures selected are psychometrically strong, sensitive to change, and have been used widely in adolescent substance abuse treatment studies.
- Conditions
- Substance Use, Delinquency, Risk for HIV Infection
- Being tested
- Multidimensional Family Therapy Cross-Systems, Enhanced Services as Usual
- Keywords
- Juvenile Offenders, HIV/STD Prevention, Adolescent Substance Abuse, 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.
Multidimensional Family Therapy Cross-SystemsBehavioural
Also called MDFT-CS
Standard initial/engagement work in the home and detention, plus a state-of-the-art HIV education prevention module as well as standard MDFT which 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.
Enhanced Services as UsualBehavioural
Also called ESAU
Standard drug treatment services in detention and state-of-the-art HIV education prevention intervention, as well as outpatient drug treatment provided by community drug treatment providers
| Study group | Role | What they receive |
|---|---|---|
| Multidimensional Family Therapy Cross-Systems | Experimental | In Stage 1 (in detention) Multidimensional Family Therapy Cross-Systems (MDFT-CS) consists of two major components: standard initial/engagement work with parents in the home and with adolescents in detention, plus a state-of-the-art HIV education prevention module. In Stage 2, MDFT-CS includes the standard MDFT components: 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. Receives: Behavioral: Multidimensional Family Therapy Cross-Systems |
| Enhanced Services as Usual | Other | In Stage 1 (in detention) ESAU includes two major components: standard drug treatment services delivered by detention staff, and state-of-the-art HIV education prevention intervention. In Stage 2, community drug treatment providers deliver high quality drug treatment on an outpatient basis. Receives: Behavioral: Enhanced Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Timeline Follow-Back Method of Drug and Alcohol Use, Urine analyses for Drug Use, Personal Experiences Inventory and the Adolescent Diagnostic Interview-Light will be used to measure substance use.
Measured: Release from detention through the 42-month follow-up
Secondary outcomes (2)
Delinquency
National Youth Survey Self-Report Delinquency Scale and the Juvenile/Criminal Justice records will be used to measure delinquency
Measured: Release from detention through the 42-month follow-up
Sexual Risk Behaviors
Timeline Followback of Sexual Risk Behaviors, Urine Analyses for Sexually Transmitted Diseases (STDs) and HIV Testing.
Measured: Release from detention through the 42-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 posted29 Jul 2013 (estimated)
- Study startApr 2006
- Primary completionSep 2008
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Liddle, University of Miami
- Investigators
- Howard A Liddle, EdD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910324
- Sponsor's protocol ID
- 20043161
- Acronym
- DTC
- Status last verified
- May 2014
- First submitted
- 25 Jul 2013
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liddle HA, Dakof GA, Henderson C, Rowe C. Implementation outcomes of Multidimensional Family Therapy-Detention to Community: a reintegration program for drug-using juvenile detainees. Int J Offender Ther Comp Criminol. 2011 Jun;55(4):587-604. doi: 10.1177/0306624X10366960. Epub 2010 Apr 28.
PubMed 20427547Marvel F, Rowe CL, Colon-Perez L, DiClemente RJ, Liddle HA. Multidimensional family therapy HIV/STD risk-reduction intervention: an integrative family-based model for drug-involved juvenile offenders. Fam Process. 2009 Mar;48(1):69-84. doi: 10.1111/j.1545-5300.2009.01268.x.
PubMed 19378646Rowe CL, Wang W, Greenbaum P, Liddle HA. Predicting HIV/STD risk level and substance use disorders among incarcerated adolescents. J Psychoactive Drugs. 2008 Dec;40(4):503-12. doi: 10.1080/02791072.2008.10400656.
PubMed 19283954Rowe CL, Alberga L, Dakof GA, Henderson CE, Ungaro R, Liddle HA. Family-Based HIV and Sexually Transmitted Infection Risk Reduction for Drug-Involved Young Offenders: 42-Month Outcomes. Fam Process. 2016 Jun;55(2):305-20. doi: 10.1111/famp.12206. Epub 2016 Feb 16.
PubMed 26879671
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Adolescent Offenders' Reintegration From Juvenile Detention to Community Life (DTC)
- ClinicalTrials.gov ID
- NCT01910324
- Acronym / sponsor ID
- DTC / 20043161
- Conditions
- Substance Use, Delinquency, Risk for HIV Infection
- Keywords
- Juvenile Offenders, HIV/STD Prevention, Adolescent Substance Abuse, Multidimensional Family Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Jul 2013 (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 fundamental objective of the proposed study is to develop and test an innovative two-stage, cross-systems family-based intervention for substance abusing juvenile offenders. The first stage of the experimental treatment is provided for youths in juvenile detention settings. Stage two of the intervention occurs after the offender is released to the community. Participants are randomized to one of two study conditions: the cross-systems family-based intervention (Multidimensional Family Therapy-Cross Systems (MDFT-CS), or 2) Enhanced Services as Usual (ESAU). Both conditions incorporate HIV prevention in detention and we will also examine the effects of a family-based HIV/STD prevention module beyond the impact of a standard HIV/STD education intervention delivered in detention by including ongoing HIV/STD intervention in MDFT-CS following release from detention. There are five aims of the proposed study. These aims relate to: 1) Intervention development and implementation; 2) Clinical effectiveness; 3) Impact of HIV/AIDS/STD prevention; 4) Comparative benefit-costs; and 5) Systems-level impact
Detailed description
This study will employ a fully randomized (2 conditions) by 9 assessment points (baseline, discharge from detention, and 3, 6, 9, 18, 24, 36 and 42 months following detention discharge), repeated measures intent-to-treat design with multiple dependent variables. 154 males and females (85 participants from Miami Dade Regional Juvenile Detention Center and 85 from Pinellas Juvenile Detention Center) who meet the study eligibility criteria will be randomized to one of the two treatment conditions.
The study will also include a 6-month pilot phase. During this phase, the MDFT detention intervention and cross-systems collaboration protocols will be developed; the existing treatment manual will be revised; the MDFT-CS with family-based HIV prevention module and standard HIV education intervention will be developed; family therapists will be trained in the MDFT intervention (including HIV/STD module); the MDFT-CS intervention will be piloted; the assessment battery will be piloted; the protocols, manual, and training package will be revised and finalized; research staff will be trained on all procedures and protocols; and data management procedures will be developed.
During Stage 1, adolescents in all intervention conditions will receive standard detention services, which include education and health care. In addition, youth assigned to the ESAU condition will receive the standard mental health and substance abuse services offered in the detention (mainly psychoeducational in nature). Youth assigned to the MDFT-CS intervention will not receive standard mental health/substance abuse services provided by the detention center, as these youth will be assigned a MDFT therapist who will address their mental health and substance abuse issues needs.
Experimental Treatment: Multidimensional Family Therapy-Cross Systems (MDFT-CS). In Stage 1 (in detention) MDFT-CS, the experimental treatment, consists of two major components: standard initial/engagement work with parents in the home and with adolescents in detention (both conducted weekly for the duration of the adolescents stay in detention), plus a state-of-the-art HIV education prevention module based on CDC-endorsed strategies. The in-detention MDFT will be delivered by therapists employed by the University of Miami/ Center for Treatment Research on Adolescent Drug Abuse (CTRADA) who will continue to treat the youth and family after release from detention. In Stage 2, the experimental treatment includes the standard MDFT components (4 overall change units/targets: adolescent, parent, family interaction, and functioning of the family members vis a vis relevant extrafamilial social systems such as school and juvenile justice).
Enhanced Services as Usual (ESAU). In Stage 1 (in detention), ESAU includes two major components - standard drug treatment services that are delivered by detention staff, and state-of-the-art HIV education prevention intervention delivered to all participating youth.
In Stage 2, community drug treatment providers deliver high quality drug treatment on an outpatient basis. To minimize heterogeneity within the comparison condition, and in order to provide better service and treatment tracking opportunities, the study will only use one community based treatment agency to deliver ESAU per locale at each Research Center.
All measures selected are psychometrically strong, sensitive to change, and have been used widely in adolescent substance abuse treatment studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidimensional Family Therapy Cross-Systems | Experimental | Behavioral: Multidimensional Family Therapy Cross-SystemsIn Stage 1 (in detention) Multidimensional Family Therapy Cross-Systems (MDFT-CS) consists of two major components: standard initial/engagement work with parents in the home and with adolescents in detention, plus a state-of-the-art HIV education prevention module. In Stage 2, MDFT-CS includes the standard MDFT components: 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. |
| Enhanced Services as Usual | Other | Behavioral: Enhanced Services as UsualIn Stage 1 (in detention) ESAU includes two major components: standard drug treatment services delivered by detention staff, and state-of-the-art HIV education prevention intervention. In Stage 2, community drug treatment providers deliver high quality drug treatment on an outpatient basis. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Be between the ages of 13 and 17
- Be incarcerated in a juvenile detention facility at intake
- Endorse substance abuse problems on the MAYSI or other intake forms
- Have at least one parent figure willing/able to participate in the intervention and research assessments
- Provide informed consent to participate in the study
Key exclusion criteria (4 listed)
- Mental retardation or pervasive developmental disorders
- Psychotic features
- Current suicidality defined as Ideation + Plan + High intention to carry out plan
- High risk to receive long-term residential placement directly from detention
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 |
|---|---|---|
| Multidimensional Family Therapy Cross-SystemsAlso: MDFT-CSStandard initial/engagement work in the home and detention, plus a state-of-the-art HIV education prevention module as well as standard MDFT which 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 | Multidimensional Family Therapy Cross-Systems |
| Enhanced Services as UsualAlso: ESAUStandard drug treatment services in detention and state-of-the-art HIV education prevention intervention, as well as outpatient drug treatment provided by community drug treatment providers | Behavioural | Enhanced Services as Usual |
Primary outcome
Substance use
Time frame: Release from detention through the 42-month follow-up
Timeline Follow-Back Method of Drug and Alcohol Use, Urine analyses for Drug Use, Personal Experiences Inventory and the Adolescent Diagnostic Interview-Light will be used to measure substance use.
2 secondary outcomes
Delinquency
Time frame: Release from detention through the 42-month follow-up
Sexual Risk Behaviors
Time frame: Release from detention through the 42-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 22 May 2014.
- Background: PubMed 20427547Liddle HA, Dakof GA, Henderson C, Rowe C. Implementation outcomes of Multidimensional Family Therapy-Detention to Community: a reintegration program for drug-using juvenile detainees. Int J Offender Ther Comp Criminol. 2011 Jun;55(4):587-604. doi: 10.1177/0306624X10366960. Epub 2010 Apr 28.
- Background: PubMed 19378646Marvel F, Rowe CL, Colon-Perez L, DiClemente RJ, Liddle HA. Multidimensional family therapy HIV/STD risk-reduction intervention: an integrative family-based model for drug-involved juvenile offenders. Fam Process. 2009 Mar;48(1):69-84. doi: 10.1111/j.1545-5300.2009.01268.x.
- Background: PubMed 19283954Rowe CL, Wang W, Greenbaum P, Liddle HA. Predicting HIV/STD risk level and substance use disorders among incarcerated adolescents. J Psychoactive Drugs. 2008 Dec;40(4):503-12. doi: 10.1080/02791072.2008.10400656.
- Derived from this study: PubMed 26879671Rowe CL, Alberga L, Dakof GA, Henderson CE, Ungaro R, Liddle HA. Family-Based HIV and Sexually Transmitted Infection Risk Reduction for Drug-Involved Young Offenders: 42-Month Outcomes. Fam Process. 2016 Jun;55(2):305-20. doi: 10.1111/famp.12206. Epub 2016 Feb 16.
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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.
Howard A Liddle, EdD principal investigator
University of Miami
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional Family Therapy Cross-Systems and Enhanced Services as Usual in people with Substance Use and Delinquency, run by University of Miami at 5 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 5 inclusion and 4 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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Substance use (time frame: Release from detention through the 42-month follow-up). 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 NCT01910324, which also lists 4 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 22 May 2014.