Home Based Treatment for Drug Use in Early Adolescents

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280228
• Other study ID #: DA016631
• Secondary ID: 5R21DA016631
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2006
• Last updated: May 25, 2011
• Start date: January 2006
• Est. completion date: May 2009

Study information

• Verified date: May 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 14 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Conduct Disorder
• Disease
• Oppositional Defiant Disorder
• Substance Abuse

Intervention

Behavioral:
• Adolescent Skills Parent Management Parent-Adol Negotiation
Acute treatment for 12 weeks followed by three monthly booster sessions.
• Treatment as Usual
Standard outpatient treatment for behavioral problems and substance use

Locations

Country	Name	City	State
United States	Youth and Family Research Program	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of substance use and disruptive behaviors		immediately following acute 12 week treatment, at the end of 3 month followup, and at one year follow up	No