Home Based Treatment for Drug Use in Early Adolescents

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Alcohol Drinking Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Chemically-Induced Disorders Conduct Disorder Drinking Behavior Mental Disorders Neurodevelopmental Disorders Oppositional Defiant Disorder Substance Abuse Substance-Related Disorders

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Youth and Family Research Program

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adolescent Skills Parent Management Parent-Adol Negotiation

Behavioral

Acute treatment for 12 weeks followed by three monthly booster sessions.

Treatment as Usual

Behavioral

Standard outpatient treatment for behavioral problems and substance use

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Jan 20, 2006
Registry last updated: May 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed