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Medication Monitoring & Case Management for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Montreal Children's Hospital, Montreal, CanadaAttention Deficit Hyperactivity Disorder (ADHD)Long-acting stimulant - Drug
Eligibility
6 - 12
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of the study is to examine how well two types of treatment follow up work compared to one another: standard community follow up medication monitoring plus tailored case management follow up. A child's participation will involve 3 months of treatment consisting of medication and psychological, behavioural, and academic interventions tailored to their individual needs. Following this treatment, the child will be randomly assigned to receive two years of either community follow up or medication monitoring plus tailored case management follow up delivered by the study team. During both types of follow up, at 6 month intervals, the parent and child will be asked to complete interviews with our study personnel and comprehensive assessments pertaining to ADHD symptoms and various other areas of functioning. Parents will also be asked to obtain information from the child's teacher regarding the child's functioning at 6 month intervals during the school year.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
DVX201
1
Alemtuzumab
1
Proton pump inhibitor

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Twenty-four months after tailored treatment has ended

Twenty-four months after tailored treatment ends - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Twenty-four months after tailored treatment has ended
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Twenty-four months after tailored treatment has ended - on medication
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Social skills (measured via Parent and Teacher Social Skills Rating Scale)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
DVX201
2
Alemtuzumab
2
Proton pump inhibitor

Trial Design

2 Treatment Groups

Community Follow-up Group
1 of 2
Medication Monitoring & Case Management
1 of 2

Active Control

Experimental Treatment

326 Total Participants · 2 Treatment Groups

Primary Treatment: Medication Monitoring & Case Management · No Placebo Group · N/A

Medication Monitoring & Case ManagementExperimental Group · 4 Interventions: Long-acting stimulant, Social Skills Training, Parent Training, Academic and Organization skills · Intervention Types: Drug, Behavioral, Behavioral, Behavioral
Community Follow-up GroupActiveComparator Group · 4 Interventions: Long-acting stimulant, Social Skills Training, Parent Training, Academic and Organization skills · Intervention Types: Drug, Behavioral, Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Social Skills Training
2022
Completed Phase 4
~2680
Parent Training
2007
Completed Phase 4
~2310

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: twenty-four months after tailored treatment has ended

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
406 Previous Clinical Trials
126,860 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
286 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,249 Previous Clinical Trials
24,678,487 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
336 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Lily Hechtman, MD, FRCPCPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
3 Previous Clinical Trials
486 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
486 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Natalie Grizenko, MD, FRCPCPrincipal InvestigatorDouglas Mental Health University Institute
1 Previous Clinical Trials
885 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
885 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Ridha Joober, MD, PhDPrincipal InvestigatorDouglas Mental Health University Institute
1 Previous Clinical Trials
885 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
885 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Age 6 - 12 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

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