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Home Based Treatment for Drug Use in Early Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280228
First Posted: January 20, 2006
Last Update Posted: May 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Pittsburgh
  Purpose
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.

Condition Intervention Phase
Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder Conduct Disorder Substance Abuse Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation Behavioral: Treatment as Usual Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home-based Behavioral Therapy (HBT): Psychosocial Intervention Project for Early Adolescents With Pre- or Early Substance Use Disorder: Phase II

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: January 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Home Based Treatment
Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation
Acute treatment for 12 weeks followed by three monthly booster sessions.
Active Comparator: 2
Treatment as Usual
Behavioral: Treatment as Usual
Standard outpatient treatment for behavioral problems and substance use

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:

  1. finalizing the HBT treatment manual and measures of treatment fidelity, therapist competence, and treatment satisfaction;
  2. generating estimates of treatment effect sizes for substance use, disruptive behavior, and functional status outcomes, as pilot data for a larger efficacy study, and
  3. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280228


Locations
United States, Pennsylvania
Youth and Family Research Program
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Oscar G Bukstein, M.D., M.P.H. University of Pittsburgh
  More Information

Responsible Party: Oscar G. Bukstein, M.D., M.P.H., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00280228     History of Changes
Other Study ID Numbers: DA016631
5R21DA016631 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2006
First Posted: January 20, 2006
Last Update Posted: May 26, 2011
Last Verified: May 2011

Keywords provided by University of Pittsburgh:
ADHD
Oppositional Defiant Disorder
Conduct Disorder
Substance Use
Drug and Alcohol Use

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Chemically-Induced Disorders