Home Based Treatment for Drug Use in Early Adolescents
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|ClinicalTrials.gov Identifier: NCT00280228|
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : May 26, 2011
|Condition or disease||Intervention/treatment||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 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home-based Behavioral Therapy (HBT): Psychosocial Intervention Project for Early Adolescents With Pre- or Early Substance Use Disorder: Phase II|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Home Based Treatment
Behavioral: Adolescent Skills Parent Management Parent-Adol Negotiation
Acute treatment for 12 weeks followed by three monthly booster sessions.
Active Comparator: 2
Treatment as Usual
Behavioral: Treatment as Usual
Standard outpatient treatment for behavioral problems and substance use
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280228
|United States, Pennsylvania|
|Youth and Family Research Program|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Oscar G Bukstein, M.D., M.P.H.||University of Pittsburgh|