Home Based Treatment for Drug Use in Early Adolescents

Phase 2

Completed

• Conditions: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder; Conduct Disorder; Substance Abuse
• Interventions: Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation; Behavioral: Treatment as Usual

• Registration Number: NCT00280228
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-20
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-25
• Last Update Posted: 2011-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adolescent Skills Parent Management Parent-Adol Negotiation	Home Based Treatment
2	Treatment as Usual	Treatment as Usual

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Youth and Family Research Program; 🇺🇸 Pittsburgh, Pennsylvania, United States