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Home Based Treatment for Drug Use in Early Adolescents

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00280228
First received: January 18, 2006
Last updated: May 25, 2011
Last verified: May 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, 5 R21 DA016631
Study First Received: January 18, 2006
Last Updated: May 25, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Hyperkinesis
Mental Disorders Diagnosed in Childhood
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013