Home Based Treatment for Drug Use in Early Adolescents

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Brief Title

Home Based Treatment for Drug Use in Early Adolescents

Official Title

Home-based Behavioral Therapy (HBT): Psychosocial Intervention Project for Early Adolescents With Pre- or Early Substance Use Disorder: Phase II

Brief Summary

      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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rates of substance use and disruptive behaviors


Condition

Attention Deficit Hyperactivity Disorder

Intervention

Adolescent Skills Parent Management Parent-Adol Negotiation

Study Arms / Comparison Groups

 1
Description:  Home Based Treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

36

Start Date

January 2006

Completion Date

May 2009

Primary Completion Date

May 2009

Eligibility 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).
      

Gender

All

Ages

11 Years - 14 Years

Accepts Healthy Volunteers

No

Contacts

Oscar G Bukstein, M.D., M.P.H., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00280228

Organization ID

DA016631

Secondary IDs

5R21DA016631


Study Sponsor

University of Pittsburgh


Study Sponsor

Oscar G Bukstein, M.D., M.P.H., Principal Investigator, University of Pittsburgh


Verification Date

May 2011