Home Based Treatment for Drug Use in Early Adolescents
May 25, 2011 updated by: University of Pittsburgh
Home-based Behavioral Therapy (HBT): Psychosocial Intervention Project for Early Adolescents With Pre- or Early Substance Use Disorder: Phase II
This study will compare two programs to see if they are helpful in preventing the use of substances in adolescents with attention deficit-hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), or conduct disorder (CD).
One of the programs involves working with adolescents and their parent(s) in their home.
The other program involves working with adolescents and their parent(s) in an office setting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study phase, 36 patients with a disruptive behavior disorder (DBD - i.e., attention deficit-hyperactivity disorder, oppositional defiant disorder, conduct disorder) and use or abuse of one or more substances will be randomly assigned to treatment using either a standard treatment for DBDs in this age group or the newly developed HBT treatment. Treatment outcomes for the 24 patients assigned to receive HBT will then be compared to outcomes for the 12 patients assigned to receive standard DBD treatment.
Specific aims of Phase II include:
- finalizing the HBT treatment manual and measures of treatment fidelity, therapist competence, and treatment satisfaction;
- generating estimates of treatment effect sizes for substance use, disruptive behavior, and functional status outcomes, as pilot data for a larger efficacy study, and
- comparing treatment satisfaction for the two treatment groups.
We hypothesize that HBT will lead to significantly lower rates of disruptive behaviors, substance use, and SUDs than with standard treatment, as well as greater concomitant improvements in impairment.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Youth and Family Research Program
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Study participants (subjects and parents) must provide written consent and verbal assent
- Adolescents aged 11 through 14 of any race or ethnic background,
- A DSM-IV disruptive behavior disorder diagnosis (either CD, ODD, ADHD or disruptive behavior disorder not otherwise specified [DBD NOS]),
- Adolescents who are either using one or more substances regularly (2 or more times a month for 3 consecutive months), and
- Acceptable insurance coverage (i.e., participant has insurance that is accepted by the University of Pittsburgh Medical Center [UPMC] in the event that they are randomly assigned to the treatment-as-usual [TAU] group).
Exclusion Criteria:
- Full scale IQ below 80;
- History of pervasive developmental disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders,
- Diagnosis of bipolar disorder,
- Recent treatment for substance problems, and/or
- Daily use of "hard" street drugs (i.e., cocaine, methamphetamine, heroin, inhalants).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Home Based Treatment
|
Acute treatment for 12 weeks followed by three monthly booster sessions.
|
|
Active Comparator: 2
Treatment as Usual
|
Standard outpatient treatment for behavioral problems and substance use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rates of substance use and disruptive behaviors
Time Frame: immediately following acute 12 week treatment, at the end of 3 month followup, and at one year follow up
|
immediately following acute 12 week treatment, at the end of 3 month followup, and at one year follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oscar G Bukstein, M.D., M.P.H., University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
January 18, 2006
First Submitted That Met QC Criteria
January 18, 2006
First Posted (Estimate)
January 20, 2006
Study Record Updates
Last Update Posted (Estimate)
May 26, 2011
Last Update Submitted That Met QC Criteria
May 25, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA016631
- 5R21DA016631 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.