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Stimulant

Medication Monitoring & Case Management for 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
age 6 to 12 years
DSM-IV ADHD diagnosis by a specialist i.e. child psychiatrist or developmental paediatrician (DSM 5 ADHD criteria do not differ dramatically from DSM IV criteria for children)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up twenty-four months after tailored treatment has ended - on medication
Awards & highlights

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)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twenty-four months after tailored treatment has ended - on medication
This trial's timeline: 3 weeks for screening, Varies for treatment, and twenty-four months after tailored treatment has ended - on medication for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Secondary outcome measures
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
+2 more

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?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,340 Previous Clinical Trials
26,452,372 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
466 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
442 Previous Clinical Trials
158,848 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
286 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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~26 spots leftby Apr 2025