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Behavioral Intervention
PT with ACBT and Methylphenidate for Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3
Waitlist Available
Led By William E Pelham, PHD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 6 months after randomization to treatment
Awards & highlights
Study Summary
This trial will test the efficacy of a brief intervention for substance use in adolescents with ADHD.
Eligible Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at 6 months after randomization to treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 6 months after randomization to treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Evidence of Illicit Substances in Urine Screen
Number of Participants With Past 90-day Alcohol Use
Secondary outcome measures
Mean Youth Self-Report of Disruptive Behaviors
Mean Youth Self-Report of Functional Impairment
Mean Youth Self-Report of Likelihood of Future Substance Use
+1 moreTrial Design
3Treatment groups
Active Control
Group I: PT with ACBT and MethylphenidateActive Control3 Interventions
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT and Methylphenidate arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (ACBT). Adolescents will also receive methylphenidate.
Group II: PT with ACBTActive Control2 Interventions
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. For participants randomized to the PT with ACBT arm, parents will participate in behavioral parent training (PT) and adolescents will participate in cognitive behavioral therapy to reduce substance use (CBT).
Group III: Continued Monitoring and AssessmentActive Control1 Intervention
All participants will receive 5 sessions of BEI. Non-responders will then be randomized to one of three conditions. Participants randomized to the continued monitoring and assessment arm will receive no additional intervention. Primary and secondary outcomes will be monitored.
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Who is running the clinical trial?
Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,397 Total Patients Enrolled
16 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,163 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
William E Pelham, PHDPrincipal InvestigatorFlorida International University
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