Clinical trial NCT00280228: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Conduct Disorder
Substance Abuse
Keywords: ADHD
Oppositional Defiant Disorder
Conduct Disorder
Substance Use
Drug and Alcohol Use
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-01-20
Enrollment: 36
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Rates of substance use and disruptive behaviors
timeFrame: immediately following acute 12 week treatment, at the end of 3 month followup, and at one year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Youth and Family Research Program
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Oscar G Bukstein, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: