Clinical trial NCT02142140: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Treatment of ADHD
Long-term treatment follow-up
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-05-20
Enrollment: 326
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
timeFrame: At baseline - no medication
measure: Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
timeFrame: Following 3 months of tailored treatment (including medication)
measure: Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
timeFrame: Six months after tailored treatment ends - on medication
measure: Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
timeFrame: Twelve months after tailored treatment has ended - on medication
measure: Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
timeFrame: Eighteen months after tailored treatment has ended - on medication
measure: Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
timeFrame: Twenty-four months after tailored treatment has ended - on medication
Secondary outcomes:
measure: Social skills (measured via Parent and Teacher Social Skills Rating Scale)
timeFrame: At baseline - no medication
measure: Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
timeFrame: At baseline - no medication
measure: Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
timeFrame: At baseline - no medication
measure: Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
timeFrame: At baseline - no medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Assessed at baseline
measure: Social skills (measured via Parent and Teacher Social Skills Rating Scale)
timeFrame: Following 3 months of tailored treatment (including medication)
measure: Social skills (measured via Parent and Teacher Social Skills Rating Scale)
timeFrame: Six months after tailored treatment ends - on medication
measure: Social skills (measured via Parent and Teacher Social Skills Rating Scale)
timeFrame: Twelve months after tailored treatment has ended - on medication
measure: Social skills (measured via Parent and Teacher Social Skills Rating Scale)
timeFrame: Eighteen months after tailored treatment has ended - on medication
measure: Social skills (measured via Parent and Teacher Social Skills Rating Scale)
timeFrame: Twenty-four months after tailored treatment has ended - on medication
measure: Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
timeFrame: Twelve month after tailored treatment has ended - on medication
measure: Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
timeFrame: Twenty-four months after tailored treatment has ended
measure: Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
timeFrame: Following 3 months of tailored treatment (including medication)
measure: Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
timeFrame: Six months after tailored treatment ends - on medication
measure: Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
timeFrame: Twelve months after tailored treatment has ended - on medication
measure: Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
timeFrame: Eighteen months after tailored treatment has ended - on medication
measure: Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
timeFrame: Twenty-four months after tailored treatment has ended - on medication
measure: Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
timeFrame: Following 3 months of tailored treatment (including medication)
measure: Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
timeFrame: Six months after tailored treatment ends - on medication
measure: Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
timeFrame: Twelve months after tailored treatment has ended - on medication
measure: Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
timeFrame: Eighteen months after tailored treatment has ended - on medication
measure: Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
timeFrame: Twenty-four months after tailored treatment has ended - on medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Following 3 months of tailored treatment (including medication)
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Three months after tailored treatment ends - on medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Six months after tailored treatment ends - on medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Nine months after tailored treatment ends - on medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Twelve months after tailored treatment ends - on medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Fifteen months after tailored treatment ends - on medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Eighteen months after tailored treatment ends - on medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Twenty-one months after tailored treatment ends - on medication
measure: Overall functioning (measured via the Clinical Global Impression Scale (CGI))
timeFrame: Twenty-four months after tailored treatment ends - on medication
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Lily Hechtman, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Douglas Mental Health University Institute
name: Natalie Grizenko, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Douglas Mental Health University Institute
name: Ridha Joober, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: