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

Information source: McGill University Health Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder (ADHD)

Intervention: Academic and Organization skills (Behavioral); Parent Training (Behavioral); Social Skills Training (Behavioral); Long-acting stimulant (Drug); Long-acting stimulant (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: McGill University Health Center

Official(s) and/or principal investigator(s):
Lily Hechtman, MD, FRCPC, Principal Investigator, Affiliation: McGill University Health Center
Natalie Grizenko, MD, FRCPC, Principal Investigator, Affiliation: Douglas Mental Health University Institute
Ridha Joober, MD, PhD, Principal Investigator, Affiliation: Douglas Mental Health University Institute

Overall contact:
Joy Etcovtich, MA, Phone: 514-412-4400, Ext: 23784, Email: joy.etcovitch@mail.mcgill.ca

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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:

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))

Overall functioning (measured via the Clinical Global Impression Scale (CGI))

Overall functioning (measured via the Clinical Global Impression Scale (CGI))

Overall functioning (measured via the Clinical Global Impression Scale (CGI))

Overall functioning (measured via the Clinical Global Impression Scale (CGI))

Overall functioning (measured via the Clinical Global Impression Scale (CGI))

Overall functioning (measured via the Clinical Global Impression Scale (CGI))

Overall functioning (measured via the Clinical Global Impression Scale (CGI))

Eligibility

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

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.

Locations and Contacts

Joy Etcovtich, MA, Phone: 514-412-4400, Ext: 23784, Email: joy.etcovitch@mail.mcgill.ca

Douglas Mental Health University Institute, Montreal, Quebec H4H 1R3, Canada; Recruiting
Johanne Bellingham, Phone: 514-761-6131, Ext: 2098, Email: johanne.bellingham@douglas.mcgill.ca
Natalie Grizenko, MD, FRCPC, Principal Investigator
Ridha Joober, MD, PhD, Principal Investigator

Montreal Children's Hospital, Montreal, Quebec H3Z 1P2, Canada; Recruiting
Joy Etcovitch, MA, Phone: 514-412-4400, Ext: 23784, Email: joy.etcovitch@mail.mcgill.ca
Lily Hechtman, MD, FRCP, Principal Investigator

Additional Information

Starting date: December 2012
Last updated: May 22, 2014

Page last updated: August 23, 2015

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