Home Based Treatment for Drug Use in Early Adolescents

NCT ID: NCT00280228

Last Updated: 2011-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-05-31

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.

Conditions

Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder; Conduct Disorder; Substance Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Home Based Treatment

Group Type: EXPERIMENTAL

Adolescent Skills Parent Management Parent-Adol Negotiation

Intervention Type: BEHAVIORAL

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

2

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: BEHAVIORAL

Standard outpatient treatment for behavioral problems and substance use

Interventions

Adolescent Skills Parent Management Parent-Adol Negotiation

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

Intervention Type: BEHAVIORAL

Treatment as Usual

Standard outpatient treatment for behavioral problems and substance use

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

University of Pittsburgh

Principal Investigators

Oscar G Bukstein, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Youth and Family Research Program

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

5R21DA016631

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA016631

Identifier Type: -

Identifier Source: org_study_id