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Home Based Treatment for Drug Use in Early Adolescents

Primary Purpose

Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adolescent Skills Parent Management Parent-Adol Negotiation
Treatment as Usual
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Oppositional Defiant Disorder, Conduct Disorder, Substance Use, Drug and Alcohol Use

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Youth and Family Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Home Based Treatment

Treatment as Usual

Outcomes

Primary Outcome Measures

Rates of substance use and disruptive behaviors

Secondary Outcome Measures

Full Information

First Posted
January 18, 2006
Last Updated
May 25, 2011
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00280228
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder, Substance Abuse
Keywords
ADHD, Oppositional Defiant Disorder, Conduct Disorder, Substance Use, Drug and Alcohol Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Home Based Treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Skills Parent Management Parent-Adol Negotiation
Intervention Description
Acute treatment for 12 weeks followed by three monthly booster sessions.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Standard outpatient treatment for behavioral problems and substance use
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar G Bukstein, M.D., M.P.H.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youth and Family Research Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Home Based Treatment for Drug Use in Early Adolescents

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