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

Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Behavioral: Academic and Organization skills; Behavioral: Parent Training; Behavioral: Social Skills Training; Drug: Long-acting stimulant; Drug: Long-acting stimulant

• Study Type: Interventional
• Enrollment (Anticipated): 326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4H 1R3
      • Douglas Mental Health University Institute
    • Montreal, Quebec, Canada, H4A 3J1
      • Montreal Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medication Monitoring & Case Management; 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).	Behavioral: Academic and Organization skills; 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.; Behavioral: Parent Training; 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.; Behavioral: Social Skills Training; 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.; Drug: Long-acting stimulant; 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.; Other Names: Concerta; Vyvanse; Adderall; Ritalin; Strattera; Dexedrine; Biphentin; Drug: Long-acting stimulant; 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.; Other Names: Concerta; Vyvanse; Adderall; Ritalin; Strattera; Dexedrine; Biphentin
Active Comparator: Community Follow-up Group; 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.	Behavioral: Academic and Organization skills; 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.; Behavioral: Parent Training; 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.; Behavioral: Social Skills Training; 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.; Drug: Long-acting stimulant; 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.; Other Names: Concerta; Vyvanse; Adderall; Ritalin; Strattera; Dexedrine; Biphentin; Drug: Long-acting stimulant; 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.; Other Names: Concerta; Vyvanse; Adderall; Ritalin; Strattera; Dexedrine; Biphentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)	At baseline - no medication
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)	Following 3 months of tailored treatment (including medication)
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)	Six months after tailored treatment ends - on medication
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)	Twelve months after tailored treatment has ended - on medication
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)	Eighteen months after tailored treatment has ended - on medication
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)	Twenty-four months after tailored treatment has ended - on medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social skills (measured via Parent and Teacher Social Skills Rating Scale)		At baseline - no medication
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))		At baseline - no medication
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		At baseline - no medication
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		At baseline - no medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))		Assessed at baseline
Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Following 3 months of tailored treatment (including medication)
Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Six months after tailored treatment ends - on medication
Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Twelve months after tailored treatment has ended - on medication
Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Eighteen months after tailored treatment has ended - on medication
Social skills (measured via Parent and Teacher Social Skills Rating Scale)		Twenty-four months after tailored treatment has ended - on medication
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))		Twelve month after tailored treatment has ended - on medication
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))		Twenty-four months after tailored treatment has ended
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Following 3 months of tailored treatment (including medication)
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Six months after tailored treatment ends - on medication
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Twelve months after tailored treatment has ended - on medication
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Eighteen months after tailored treatment has ended - on medication
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))		Twenty-four months after tailored treatment has ended - on medication
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Following 3 months of tailored treatment (including medication)
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Six months after tailored treatment ends - on medication
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Twelve months after tailored treatment has ended - on medication
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Eighteen months after tailored treatment has ended - on medication
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))		Twenty-four months after tailored treatment has ended - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))		Following 3 months of tailored treatment (including medication)
Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Three months after tailored treatment ends - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Six months after tailored treatment ends - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Nine months after tailored treatment ends - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Twelve months after tailored treatment ends - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Fifteen months after tailored treatment ends - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Eighteen months after tailored treatment ends - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Twenty-one months after tailored treatment ends - on medication
Overall functioning (measured via the Clinical Global Impression Scale (CGI))	For participants randomized to the medication monitoring and tailored case management follow-up group.	Twenty-four months after tailored treatment ends - on medication

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Ridha Joober, MD, PhD, Douglas Mental Health University Institute; Principal Investigator: Natalie Grizenko, MD, FRCPC, Douglas Mental Health University Institute; Principal Investigator: Lily Hechtman, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (Estimate): May 20, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Treatment of ADHD; Long-term treatment follow-up
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Adrenergic Uptake Inhibitors; Methylphenidate; Lisdexamfetamine Dimesylate; Atomoxetine Hydrochloride; Dextroamphetamine; Adderall; Central Nervous System Stimulants
• Other Study ID Numbers: MOP 123412