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CompletedNCT00280228Updated May 26, 2011

Home Based Treatment for Drug Use in Early Adolescents

A Phase 2 interventional study of Adolescent Skills Parent Management Parent-Adol Negotiation and Treatment as Usual in Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder and Conduct Disorder, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 11 Years to 14 Years. Per ClinicalTrials.gov, last updated 2011-05-26.

Sponsored by University of Pittsburgh · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
11 Years to 14 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
  • Oppositional Defiant Disorder
  • Conduct Disorder
  • Substance Abuse

Keywords

  • ADHD
  • Oppositional Defiant Disorder
  • Conduct Disorder
  • Substance Use
  • Drug and Alcohol Use
03

In context

Attention Deficit Disorder with Hyperactivity

1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's planned enrollment of 36 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    1

    Home Based Treatment

    Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation

  • Active comparator
    2

    Treatment as Usual

    Behavioral: Treatment as Usual

Interventions

  • BehavioralAdolescent Skills Parent Management Parent-Adol Negotiation

    Acute treatment for 12 weeks followed by three monthly booster sessions.

  • BehavioralTreatment as Usual

    Standard outpatient treatment for behavioral problems and substance use

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Youth and Family Research Program
    Pittsburgh, Pennsylvania 15213, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2006, a primary completion of May 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2006
First posted
Jan 20, 2006
Start
Jan 2006
Primary completionActual
May 2009
CompletionActual
May 2009
Last update
May 26, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00280228
First posted
Jan 20, 2006
Start date
Jan 2006
Primary completion
May 2009
Completion
May 2009
Last update
May 26, 2011

Study contacts

Oscar G Bukstein, M.D., M.P.H.
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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