Attention Deficit Hyperactivity Disorder Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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