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Stimulant
Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
N/A
Waitlist Available
Led By Natalie Grizenko, MD, FRCPC
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
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 twenty-four months after tailored treatment ends - on medication
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
The purpose of the study is to examine how well two types of treatment follow up work compared to one another: 1. standard community follow up 2. 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)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ twenty-four months after tailored treatment ends - on medication
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twenty-four months after tailored treatment ends - on medication
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medication Monitoring & Case ManagementExperimental Treatment4 Interventions
All children entered into this study will be prescribed medication for their ADHD symptoms (usually a long-acting stimulant). Based on the individual needs of the child and family, they could receive the following interventions - Academic and organization skills, social skills training and parent training. Participants randomized to this group will meet with the study clinicians 4 times a year for medication monitoring and adjustment. This group will also receive a monthly call from a case manager who will explore the child's academic, social and emotional functioning. Depending on the needs of the child and family, the case manager may offer 1 to 5 intervention sessions with the child (e.g. social skills, anger management), the family (e.g. family counselling), and the school (e.g. consultation with the teacher).
Group II: Community Follow-up GroupActive Control4 Interventions
All children entered into this study will be prescribed medication for their ADHD symptoms (usually a long-acting stimulant). Based on the individual needs of the child and family, they could receive the following interventions - Academic and organization skills, social skills training and parent training. Families randomized to this group will be referred to their pediatricians or family physicians for medication follow-up and their local Community Health Clinic (CLSC) for other psychosocial interventions that may be required and available.
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
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
471 Previous Clinical Trials
166,681 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
1,392 Previous Clinical Trials
26,529,119 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
466 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)
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)