Substance UseARTNCT01737632
Family-based and Adolescent Residential Drug Treatment
A study testing Multidimensional Family Therapy (MDFT) and Adolescent Residential Treatment in people with Substance Use and Delinquency, run by University of Miami at 2 sites in United States.
Trial summary
The fundamental objective of this study is to compare the effectiveness of an intensive in-home family-based treatment, Multidimensional Family Therapy, with a multifaceted residential treatment, Adolescent Residential Treatment, over 4 years post-intake and to delineate the mechanisms of change for each treatment. 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
- What is being tested?
- Multidimensional Family Therapy (MDFT) and Adolescent Residential Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2000to Jun 2010
- 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
- Youth between the ages of 13 and 17
- Referred to ATP for residential substance abuse treatment in youth dual diagnosis program
- Dually diagnosed for substance abuse or dependence and at least one of the following co-morbid conditions: major depressive disorder, bipolar disorder, I conduct disorder, oppositional defiant disorder,
- At least one parent or parent-figure can be located at the time of referral.
- Obtain informed consent from a parent or formal guardian and assent from youth to participate in the study.
Who cannot join
- Have any of the following disorders: Mental Retardation, Eating Disorders, Schizophrenia, or Pervasive Developmental Disorders.
- Current suicidality.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Miller School of Medicine
Miami, Florida, 33136
The Village, Inc.
Miami, Florida, 33137
About this study
Official title: Family-Based Versus Adolescent Residential Drug Treatment
The fundamental objective of this study is to compare the effectiveness of an intensive in-home family-based treatment, Multidimensional Family Therapy, with a multifaceted residential treatment, Adolescent Residential Treatment, over 4 years post-intake and to delineate the mechanisms of change for each treatment. The study targets dually- diagnosed adolescent drug abusers recommended for residential treatment.
Read the detailed description
Aim 1: To compare the effectiveness of residential treatment with outpatient, family-based treatment multiple outcomes including substance use, mental health, school functioning, family function and delinquency among dually diagnosed adolescents.
Hypothesis 1. From intake to 2 months, residential treatment will show better outcomes than the family based treatment. Between 2 months and 18 months, family based treatment will show better outcomes than residential. Between 18 months and four years post intake, outpatient family based treatment will maintain its treatment gains, while the residential treatment condition will show an increase in these same symptoms and behaviors.
Aim 2: To examine the relationship between predictors (family, peer, educational/vocational functioning and involvement in post-treatment services), and outcomes (drug use, co-morbid symptoms, and criminal behavior) during the four-year post intake period.
Hypothesis 2a. Family functioning, educational/vocational functioning, and peer relationships measured at discharge will predict drug use, co-morbid symptoms, and criminal behaviors though the four year longer term follow up period.
Hypothesis 2b. Family functioning, educational/vocational functioning, peer relationships, and involvement in post-treatment services during the post treatment period will predict drug use, co-morbid symptoms, and criminal behavior through the longer term follow up period.
Research Question 1. Is the rate of change in family functioning, educational/vocational functioning, peer relationships, and involvement in post-treatment services related to the rate of change in drug use, co-morbid symptoms, and criminal behavior?
- Conditions
- Substance Use, Delinquency
- Being tested
- Multidimensional Family Therapy (MDFT), Adolescent Residential Treatment
- Keywords
- Adolescents, Residential Treatment, Outpatient Treatment, 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.
Multidimensional Family Therapy (MDFT)Behavioural
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.
Adolescent Residential TreatmentBehavioural
The Adolescent Treatment Program targets the adolescent's abuse or dependency on chemicals while simultaneously treating the comorbid symptomatology found in dual diagnosed patients. These goals are accomplished by using four primary forms of intervention: (1) Chemical Education; (2) Group, Individual and Family Counseling; (3) Twelve Step Work; and 4) Psychotropic Medication for Clinical Symptomatology Comorbid with Substance Abuse.
| Study group | Role | What they receive |
|---|---|---|
| Multidimensional Family Therapy (MDFT) | Experimental | MDFT is an intensive, in-home family-based drug abuse treatment for adolescent substance abusers. MDFT views family factors in their context -in terms of the network (individual, familial, peer, community) or multiplicity of influences on drug use and change. Receives: Behavioral: Multidimensional Family Therapy (MDFT) |
| Adolescent Residential Treatment | Other | The Adolescent Treatment Program (ATP) is a residential dual diagnosed substance abuse treatment program that is staff secure. It is based on a social learning approach which emphasizes positive reinforcement for appropriate coping behavior and social skills, and incorporates a "levels" system which allocates privileges and responsibilities according to the individual's behavioral capacities. Receives: Behavioral: Adolescent Residential Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Personal Involvement with Chemicals
Scale from the Personal Experience Inventory (PEI) developed by Ken Winter.
Measured: Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline
Change in substance use consumption
Measure of substance use consumption as measured by the Timeline Follow-back Method.
Measured: Baseline, 2, 4, 12,18,24,36,48 months after intake
Change in externalizing symptoms
Externalizing symptoms measured by the Youth Self Report
Measured: Baseline, 2, 4, 12, 18, 24, 36 and 48 months
Change in delinquency
Measured by youth report on the Self Report Delinquency Scale.
Measured: Intake, 2, 4, 12, 18, 24, 35, 48 months after intake
Change in internalzing symptoms
Measured by the Youth Self Report (YSR)
Measured: Intake, 2, 4, 12, 18, 24, 36, 48 months after baseline
Secondary outcomes (3)
Change in family conflict
Parent and youth report on their family conflict as measured by the Family Environment Scale.
Measured: Baseline, 2, 4, 12, 18, 24, 36, 48 months after baseline
Change in parenting practices
Measures the extent to which parents monitor, set limits, and provide affection to their teens.
Measured: Baseline, 2, 4, 12, 18, 24,36, 48 months after baseline
Change in family cohesion
Youth and parent reports of family closeness measured by the Family Environment Scale (FES)
Measured: Intake, 2, 4, 12, 18, 24, 26, 48 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 posted29 Nov 2012 (estimated)
- Study startAug 2000
- Primary completionJun 2008
- Study completionJun 2010
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
- 113 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
- NCT01737632
- Sponsor's protocol ID
- P50DA011328
- Acronym
- ART
- Status last verified
- Nov 2012
- First submitted
- 20 Nov 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zavala SK, French MT, Henderson CE, Alberga L, Rowe C, Liddle HA. Guidelines and challenges for estimating the economic costs and benefits of adolescent substance abuse treatments. J Subst Abuse Treat. 2005 Oct;29(3):191-205. doi: 10.1016/j.jsat.2005.06.004.
PubMed 16183468
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Versus Adolescent Residential Drug Treatment
- ClinicalTrials.gov ID
- NCT01737632
- Acronym / sponsor ID
- ART / P50DA011328
- Conditions
- Substance Use, Delinquency
- Keywords
- Adolescents, Residential Treatment, Outpatient Treatment, Substance Abuse, Delinquency, Family Therapy, Multidimensional Family therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Nov 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 fundamental objective of this study is to compare the effectiveness of an intensive in-home family-based treatment, Multidimensional Family Therapy, with a multifaceted residential treatment, Adolescent Residential Treatment, over 4 years post-intake and to delineate the mechanisms of change for each treatment. The study targets dually- diagnosed adolescent drug abusers recommended for residential treatment.
Detailed description
Aim 1: To compare the effectiveness of residential treatment with outpatient, family-based treatment multiple outcomes including substance use, mental health, school functioning, family function and delinquency among dually diagnosed adolescents.
Hypothesis 1. From intake to 2 months, residential treatment will show better outcomes than the family based treatment. Between 2 months and 18 months, family based treatment will show better outcomes than residential. Between 18 months and four years post intake, outpatient family based treatment will maintain its treatment gains, while the residential treatment condition will show an increase in these same symptoms and behaviors.
Aim 2: To examine the relationship between predictors (family, peer, educational/vocational functioning and involvement in post-treatment services), and outcomes (drug use, co-morbid symptoms, and criminal behavior) during the four-year post intake period.
Hypothesis 2a. Family functioning, educational/vocational functioning, and peer relationships measured at discharge will predict drug use, co-morbid symptoms, and criminal behaviors though the four year longer term follow up period.
Hypothesis 2b. Family functioning, educational/vocational functioning, peer relationships, and involvement in post-treatment services during the post treatment period will predict drug use, co-morbid symptoms, and criminal behavior through the longer term follow up period.
Research Question 1. Is the rate of change in family functioning, educational/vocational functioning, peer relationships, and involvement in post-treatment services related to the rate of change in drug use, co-morbid symptoms, and criminal behavior?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidimensional Family Therapy (MDFT) | Experimental | Behavioral: Multidimensional Family Therapy (MDFT)MDFT is an intensive, in-home family-based drug abuse treatment for adolescent substance abusers. MDFT views family factors in their context -in terms of the network (individual, familial, peer, community) or multiplicity of influences on drug use and change. |
| Adolescent Residential Treatment | Other | Behavioral: Adolescent Residential TreatmentThe Adolescent Treatment Program (ATP) is a residential dual diagnosed substance abuse treatment program that is staff secure. It is based on a social learning approach which emphasizes positive reinforcement for appropriate coping behavior and social skills, and incorporates a "levels" system which allocates privileges and responsibilities according to the individual's behavioral capacities. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Youth between the ages of 13 and 17
- Referred to ATP for residential substance abuse treatment in youth dual diagnosis program
- Dually diagnosed for substance abuse or dependence and at least one of the following co-morbid conditions: major depressive disorder, bipolar disorder, I conduct disorder, oppositional defiant disorder,
- At least one parent or parent-figure can be located at the time of referral.
- Obtain informed consent from a parent or formal guardian and assent from youth to participate in the study.
Key exclusion criteria (2 listed)
- Have any of the following disorders: Mental Retardation, Eating Disorders, Schizophrenia, or Pervasive Developmental Disorders.
- Current suicidality.
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 (MDFT)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. | Behavioural | Multidimensional Family Therapy (MDFT) |
| Adolescent Residential TreatmentThe Adolescent Treatment Program targets the adolescent's abuse or dependency on chemicals while simultaneously treating the comorbid symptomatology found in dual diagnosed patients. These goals are accomplished by using four primary forms of intervention: (1) Chemical Education; (2) Group, Individual and Family Counseling; (3) Twelve Step Work; and 4) Psychotropic Medication for Clinical Symptomatology Comorbid with Substance Abuse. | Behavioural | Adolescent Residential Treatment |
Primary outcome
Change in Personal Involvement with Chemicals
Time frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline
Scale from the Personal Experience Inventory (PEI) developed by Ken Winter.
Change in substance use consumption
Time frame: Baseline, 2, 4, 12,18,24,36,48 months after intake
Measure of substance use consumption as measured by the Timeline Follow-back Method.
Change in externalizing symptoms
Time frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months
Externalizing symptoms measured by the Youth Self Report
Change in delinquency
Time frame: Intake, 2, 4, 12, 18, 24, 35, 48 months after intake
Measured by youth report on the Self Report Delinquency Scale.
Change in internalzing symptoms
Time frame: Intake, 2, 4, 12, 18, 24, 36, 48 months after baseline
Measured by the Youth Self Report (YSR)
3 secondary outcomes
Change in family conflict
Time frame: Baseline, 2, 4, 12, 18, 24, 36, 48 months after baseline
Change in parenting practices
Time frame: Baseline, 2, 4, 12, 18, 24,36, 48 months after baseline
Change in family cohesion
Time frame: Intake, 2, 4, 12, 18, 24, 26, 48 months after intake
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 29 Nov 2012.
- Background: PubMed 16183468Zavala SK, French MT, Henderson CE, Alberga L, Rowe C, Liddle HA. Guidelines and challenges for estimating the economic costs and benefits of adolescent substance abuse treatments. J Subst Abuse Treat. 2005 Oct;29(3):191-205. doi: 10.1016/j.jsat.2005.06.004.
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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
2 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 (MDFT) and Adolescent Residential Treatment in people with Substance Use and Delinquency, run by University of Miami at 2 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 2 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 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Change in Personal Involvement with Chemicals (time frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline). The study lists 5 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 NCT01737632, 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 29 Nov 2012.