Home Based Treatment for Drug Use in Early Adolescents

• ClinicalTrials.gov Identifier: NCT00280228
• Recruitment Status: Completed
• First Posted: January 20, 2006
• Last Update Posted: May 26, 2011
• Sponsor: University of Pittsburgh
• Information provided by: University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder; Conduct Disorder; Substance Abuse	Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation; Behavioral: Treatment as Usual	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Home-based Behavioral Therapy (HBT): Psychosocial Intervention Project for Early Adolescents With Pre- or Early Substance Use Disorder: Phase II
• Study Start Date: January 2006
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Home Based Treatment	Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation; Acute treatment for 12 weeks followed by three monthly booster sessions.
Active Comparator: 2; Treatment as Usual	Behavioral: Treatment as Usual; Standard outpatient treatment for behavioral problems and substance use

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 11 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, Pennsylvania

Youth and Family Research Program

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

• Principal Investigator: Oscar G Bukstein, M.D., M.P.H.; University of Pittsburgh

More Information

• Responsible Party: Oscar G. Bukstein, M.D., M.P.H., University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00280228
• Other Study ID Numbers: DA016631; 5R21DA016631 ( U.S. NIH Grant/Contract )
• First Posted: January 20, 2006
• Last Update Posted: May 26, 2011
• Last Verified: May 2011

Keywords provided by University of Pittsburgh:

ADHD; Oppositional Defiant Disorder; Conduct Disorder; Substance Use; Drug and Alcohol Use

Additional relevant MeSH terms:

Disease; Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders; Pathologic Processes; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced Disorders