Home Based Treatment for Drug Use in Early Adolescents | NCT00280228

Studies
Home Based Treatment for Drug Use in Early Adolescents

NCT00280228

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

May 26, 2011Estimated

Enrollment

36Estimated

Phase

Phase 2

Conditions

Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Conduct Disorder
Substance Abuse

Interventions

Adolescent Skills Parent Management Parent-Adol Negotiation
Treatment as Usual

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R21DA016631	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jan 18, 2006

First Submission Date that Met QC Criteria

Jan 18, 2006

First Posted Date

Jan 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2011

Last Update Posted Date

May 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Home Based Treatment	Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation
2	Active Comparator	Treatment as Usual	Behavioral: Treatment as Usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adolescent Skills Parent Management Parent-Adol Negotiation	Behavioral	Acute treatment for 12 weeks followed by three monthly booster sessions.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oscar G Bukstein, M.D., M.P.H.	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Youth and Family Research Program		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D000096865	Oppositional Defiant Disorder
D019955	Conduct Disorder
D019966	Substance-Related Disorders
D000428	Alcohol Drinking

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided