Attention Deficit Hyperactivity DisorderPhase 2NCT00280228
Home Based Treatment for Drug Use in Early Adolescents
A Phase 2 study testing Adolescent Skills Parent Management Parent-Adol Negotiation and Treatment as Usual in people with Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder
- What is being tested?
- Adolescent Skills Parent Management Parent-Adol Negotiation and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Youth and Family Research Program
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Home-based Behavioral Therapy (HBT): Psychosocial Intervention Project for Early Adolescents With Pre- or Early Substance Use Disorder: Phase II
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder, Substance Abuse
- Being tested
- Adolescent Skills Parent Management Parent-Adol Negotiation, Treatment as Usual
- Keywords
- ADHD, Oppositional Defiant Disorder, Conduct Disorder, Substance Use, Drug and Alcohol Use
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder, Conduct Disorder, Substance-Related Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Skills Parent Management Parent-Adol NegotiationBehavioural
Acute treatment for 12 weeks followed by three monthly booster sessions.
Treatment as UsualBehavioural
Standard outpatient treatment for behavioral problems and substance use
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Home Based Treatment Receives: Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation |
| 2 | Active comparator | Treatment as Usual Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of substance use and disruptive behaviors
Measured: immediately following acute 12 week treatment, at the end of 3 month followup, and at one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Oscar G Bukstein, M.D., M.P.H., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280228
- Sponsor's protocol ID
- DA016631
- Other IDs
- 5R21DA016631
- Status last verified
- May 2011
- First submitted
- 18 Jan 2006
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Behavioral Therapy (HBT): Psychosocial Intervention Project for Early Adolescents With Pre- or Early Substance Use Disorder: Phase II
- ClinicalTrials.gov ID
- NCT00280228
- Acronym / sponsor ID
- DA016631
- Conditions
- Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder, Substance Abuse
- Keywords
- ADHD, Oppositional Defiant Disorder, Conduct Disorder, Substance Use, Drug and Alcohol Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Adolescent Skills Parent Management Parent-Adol NegotiationHome Based Treatment |
| 2 | Active comparator | Behavioral: Treatment as UsualTreatment as Usual |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adolescent Skills Parent Management Parent-Adol NegotiationAcute treatment for 12 weeks followed by three monthly booster sessions. | Behavioural | 1 |
| Treatment as UsualStandard outpatient treatment for behavioral problems and substance use | Behavioural | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar G Bukstein, M.D., M.P.H. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adolescent Skills Parent Management Parent-Adol Negotiation and Treatment as Usual in people with Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2011.