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Home Based Treatment for Drug Use in Early Adolescents

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University of Pittsburgh

Status and phase

Completed
Phase 2

Conditions

Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Conduct Disorder
Substance Abuse

Treatments

Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation
Behavioral: Treatment as Usual

Study type

Interventional

Funder types

Other

Identifiers

NCT00280228
5R21DA016631 (U.S. NIH Grant/Contract)
DA016631

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

11 to 14 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

1
Experimental group
Description:
Home Based Treatment
Treatment:
Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation
2
Active Comparator group
Description:
Treatment as Usual
Treatment:
Behavioral: Treatment as Usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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