Home Based Treatment for Drug Use in Early Adolescents - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00280228

Purpose

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	Intervention	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 II

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Home-Based Behavioral Therapy (HBT): Psychosocial Intervention Project for Early Adolescents With Pre- or Early Substance Use Disorder: Phase II

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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

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:

finalizing the HBT treatment manual and measures of treatment fidelity, therapist competence, and treatment satisfaction;
generating estimates of treatment effect sizes for substance use, disruptive behavior, and functional status outcomes, as pilot data for a larger efficacy study, and
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

Ages Eligible for Study:	11 Years to 14 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280228

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:	University of Pittsburgh ( Oscar G. Bukstein, M.D., M.P.H. )
Study ID Numbers:	DA016631, 5 R21 DA016631
Study First Received:	January 18, 2006
Last Updated:	June 3, 2008
ClinicalTrials.gov Identifier:	NCT00280228
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

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

Study placed in the following topic categories:

Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Disorders of Environmental Origin
Alcohol Drinking
Dyskinesias
Signs and Symptoms
Oppositional defiant disorder

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Substance-Related Disorders
Hyperkinesis
Neurologic Manifestations
Ethanol

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009