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Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Academic and Organization skills
Parent Training
Social Skills Training
Long-acting stimulant
Long-acting stimulant
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring Treatment of ADHD, Long-term treatment follow-up

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)
  • Intelligence Quotient (IQ) > 80 as per the Wechsler Intelligence Scale for Children (WISC-IV)
  • Proficiency in English or French

Exclusion Criteria:

  • History of Autism Spectrum Disorder (ASD) or psychosis
  • Significant brain traumas (encephalitis, head injury requiring hospitalization, etc.)
  • Major medical conditions or impairments that would interfere with the ability of the child to complete testing or take psychostimulants, e.g., epilepsy, cardiac abnormalities, or renal abnormalities.

Sites / Locations

  • Montreal Children's Hospital
  • Douglas Mental Health University Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medication Monitoring & Case Management

Community Follow-up Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)

Secondary Outcome Measures

Social skills (measured via Parent and Teacher Social Skills Rating Scale)
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 Weiss Functional Impairment Scale (WFIRS))
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
For participants randomized to the medication monitoring and tailored case management follow-up group.
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
For participants randomized to the medication monitoring and tailored case management follow-up group.
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
For participants randomized to the medication monitoring and tailored case management follow-up group.
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
For participants randomized to the medication monitoring and tailored case management follow-up group.
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
For participants randomized to the medication monitoring and tailored case management follow-up group.
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
For participants randomized to the medication monitoring and tailored case management follow-up group.
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
For participants randomized to the medication monitoring and tailored case management follow-up group.
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
For participants randomized to the medication monitoring and tailored case management follow-up group.

Full Information

First Posted
May 14, 2014
Last Updated
August 27, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02142140
Brief Title
Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
Treatment of ADHD, Long-term treatment follow-up

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medication Monitoring & Case Management
Arm Type
Experimental
Arm Description
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).
Arm Title
Community Follow-up Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Academic and Organization skills
Intervention Description
This program aims at teaching children organization, time management and stress management skills. They are also taught academic strategies in reading, writing, and math. The program consists of six, 90 minute sessions.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training
Intervention Description
The Parent Training Program: The parent training program is designed to increase parental understanding of ADHD; establish attentive, positive interactions, and solve problems collaboratively. Eight weekly group sessions lasting about 2 hours each will be conducted by trained psychologists, social workers, or clinical nurses. Homework assignments and detailed summary sheets will be used to promote technique acquisition and generalization.
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Intervention Description
Social Skills and Anger Management Training: The social skills training program is based on understanding yourself and others, and being able to understand things from the other's perspective. The program uses direct instruction, modelling, behavioural rehearsal, feedback, and social reinforcement. The following are covered: joining in, understanding emotions, dealing with anger, using self-control, responding to teasing / bullying, and staying out of fights.
Intervention Type
Drug
Intervention Name(s)
Long-acting stimulant
Other Intervention Name(s)
Biphentin, Strattera, Concerta, Ritalin, Vyvanse, Adderall, Dexedrine
Intervention Description
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable). Once optimal dose is reached, children are followed at regular once per three month visits for medication monitoring. In this group the child can be referred for a medication reevaluation and adjustment as many times as is needed.
Intervention Type
Drug
Intervention Name(s)
Long-acting stimulant
Other Intervention Name(s)
Biphentin, Strattera, Concerta, Ritalin, Vyvanse, Adderall, Dexedrine
Intervention Description
The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable). Once optimal dose is reached, children are followed by their pediatrician, with a frequency at his/her discretion.
Primary Outcome Measure Information:
Title
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Time Frame
At baseline - no medication
Title
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Time Frame
Following 3 months of tailored treatment (including medication)
Title
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Time Frame
Six months after tailored treatment ends - on medication
Title
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Time Frame
Twelve months after tailored treatment has ended - on medication
Title
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Time Frame
Eighteen months after tailored treatment has ended - on medication
Title
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
Time Frame
Twenty-four months after tailored treatment has ended - on medication
Secondary Outcome Measure Information:
Title
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Time Frame
At baseline - no medication
Title
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Time Frame
At baseline - no medication
Title
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Time Frame
At baseline - no medication
Title
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Time Frame
At baseline - no medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Time Frame
Assessed at baseline
Title
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Time Frame
Following 3 months of tailored treatment (including medication)
Title
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Time Frame
Six months after tailored treatment ends - on medication
Title
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Time Frame
Twelve months after tailored treatment has ended - on medication
Title
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Time Frame
Eighteen months after tailored treatment has ended - on medication
Title
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
Time Frame
Twenty-four months after tailored treatment has ended - on medication
Title
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Time Frame
Twelve month after tailored treatment has ended - on medication
Title
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
Time Frame
Twenty-four months after tailored treatment has ended
Title
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Time Frame
Following 3 months of tailored treatment (including medication)
Title
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Time Frame
Six months after tailored treatment ends - on medication
Title
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Time Frame
Twelve months after tailored treatment has ended - on medication
Title
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Time Frame
Eighteen months after tailored treatment has ended - on medication
Title
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
Time Frame
Twenty-four months after tailored treatment has ended - on medication
Title
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Time Frame
Following 3 months of tailored treatment (including medication)
Title
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Time Frame
Six months after tailored treatment ends - on medication
Title
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Time Frame
Twelve months after tailored treatment has ended - on medication
Title
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Time Frame
Eighteen months after tailored treatment has ended - on medication
Title
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
Time Frame
Twenty-four months after tailored treatment has ended - on medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Time Frame
Following 3 months of tailored treatment (including medication)
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Description
For participants randomized to the medication monitoring and tailored case management follow-up group.
Time Frame
Three months after tailored treatment ends - on medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Description
For participants randomized to the medication monitoring and tailored case management follow-up group.
Time Frame
Six months after tailored treatment ends - on medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Description
For participants randomized to the medication monitoring and tailored case management follow-up group.
Time Frame
Nine months after tailored treatment ends - on medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Description
For participants randomized to the medication monitoring and tailored case management follow-up group.
Time Frame
Twelve months after tailored treatment ends - on medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Description
For participants randomized to the medication monitoring and tailored case management follow-up group.
Time Frame
Fifteen months after tailored treatment ends - on medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Description
For participants randomized to the medication monitoring and tailored case management follow-up group.
Time Frame
Eighteen months after tailored treatment ends - on medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Description
For participants randomized to the medication monitoring and tailored case management follow-up group.
Time Frame
Twenty-one months after tailored treatment ends - on medication
Title
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
Description
For participants randomized to the medication monitoring and tailored case management follow-up group.
Time Frame
Twenty-four months after tailored treatment ends - on medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Intelligence Quotient (IQ) > 80 as per the Wechsler Intelligence Scale for Children (WISC-IV) Proficiency in English or French Exclusion Criteria: History of Autism Spectrum Disorder (ASD) or psychosis Significant brain traumas (encephalitis, head injury requiring hospitalization, etc.) Major medical conditions or impairments that would interfere with the ability of the child to complete testing or take psychostimulants, e.g., epilepsy, cardiac abnormalities, or renal abnormalities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lily Hechtman, MD, FRCPC
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natalie Grizenko, MD, FRCPC
Organizational Affiliation
Douglas Mental Health University Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ridha Joober, MD, PhD
Organizational Affiliation
Douglas Mental Health University Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Douglas Mental Health University Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)

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