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Trial record 35 of 1484 for:    child psychiatry

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02142140
Recruitment Status : Active, not recruiting
First Posted : May 20, 2014
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Lily Hechtman, McGill University Health Center

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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder (ADHD) Behavioral: Academic and Organization skills Behavioral: Parent Training Behavioral: Social Skills Training Drug: Long-acting stimulant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder
Study Start Date : December 2012
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


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:
  • Biphentin
  • Strattera
  • Concerta
  • Ritalin
  • Vyvanse
  • Adderall
  • Dexedrine

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 by their pediatrician, with a frequency at his/her discretion.
Other Names:
  • Biphentin
  • Strattera
  • Concerta
  • Ritalin
  • Vyvanse
  • Adderall
  • Dexedrine




Primary Outcome Measures :
  1. Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version) [ Time Frame: At baseline - no medication ]
  2. 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) ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 Measures :
  1. Social skills (measured via Parent and Teacher Social Skills Rating Scale) [ Time Frame: At baseline - no medication ]
  2. Academic achievement (measured via Wechsler Individual Achievement Test (WIAT)) [ Time Frame: At baseline - no medication ]
  3. Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL)) [ Time Frame: At baseline - no medication ]
  4. Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS)) [ Time Frame: At baseline - no medication ]
  5. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Assessed at baseline ]
  6. Social skills (measured via Parent and Teacher Social Skills Rating Scale) [ Time Frame: Following 3 months of tailored treatment (including medication) ]
  7. Social skills (measured via Parent and Teacher Social Skills Rating Scale) [ Time Frame: Six months after tailored treatment ends - on medication ]
  8. Social skills (measured via Parent and Teacher Social Skills Rating Scale) [ Time Frame: Twelve months after tailored treatment has ended - on medication ]
  9. Social skills (measured via Parent and Teacher Social Skills Rating Scale) [ Time Frame: Eighteen months after tailored treatment has ended - on medication ]
  10. Social skills (measured via Parent and Teacher Social Skills Rating Scale) [ Time Frame: Twenty-four months after tailored treatment has ended - on medication ]
  11. Academic achievement (measured via Wechsler Individual Achievement Test (WIAT)) [ Time Frame: Twelve month after tailored treatment has ended - on medication ]
  12. Academic achievement (measured via Wechsler Individual Achievement Test (WIAT)) [ Time Frame: Twenty-four months after tailored treatment has ended ]
  13. Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL)) [ Time Frame: Following 3 months of tailored treatment (including medication) ]
  14. Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL)) [ Time Frame: Six months after tailored treatment ends - on medication ]
  15. Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL)) [ Time Frame: Twelve months after tailored treatment has ended - on medication ]
  16. Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL)) [ Time Frame: Eighteen months after tailored treatment has ended - on medication ]
  17. 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 ]
  18. Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS)) [ Time Frame: Following 3 months of tailored treatment (including medication) ]
  19. Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS)) [ Time Frame: Six months after tailored treatment ends - on medication ]
  20. Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS)) [ Time Frame: Twelve months after tailored treatment has ended - on medication ]
  21. Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS)) [ Time Frame: Eighteen months after tailored treatment has ended - on medication ]
  22. Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS)) [ Time Frame: Twenty-four months after tailored treatment has ended - on medication ]
  23. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Following 3 months of tailored treatment (including medication) ]
  24. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Three months after tailored treatment ends - on medication ]
    For participants randomized to the medication monitoring and tailored case management follow-up group.

  25. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Six months after tailored treatment ends - on medication ]
    For participants randomized to the medication monitoring and tailored case management follow-up group.

  26. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Nine months after tailored treatment ends - on medication ]
    For participants randomized to the medication monitoring and tailored case management follow-up group.

  27. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Twelve months after tailored treatment ends - on medication ]
    For participants randomized to the medication monitoring and tailored case management follow-up group.

  28. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Fifteen months after tailored treatment ends - on medication ]
    For participants randomized to the medication monitoring and tailored case management follow-up group.

  29. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Eighteen months after tailored treatment ends - on medication ]
    For participants randomized to the medication monitoring and tailored case management follow-up group.

  30. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Twenty-one months after tailored treatment ends - on medication ]
    For participants randomized to the medication monitoring and tailored case management follow-up group.

  31. Overall functioning (measured via the Clinical Global Impression Scale (CGI)) [ Time Frame: Twenty-four months after tailored treatment ends - on medication ]
    For participants randomized to the medication monitoring and tailored case management follow-up group.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142140


Locations
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Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
Douglas Mental Health University Institute
Montreal, Quebec, Canada, H4H 1R3
Sponsors and Collaborators
McGill University Health Center
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Lily Hechtman, MD, FRCPC McGill University Health Center
Principal Investigator: Natalie Grizenko, MD, FRCPC Douglas Mental Health University Institute
Principal Investigator: Ridha Joober, MD, PhD Douglas Mental Health University Institute

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Responsible Party: Lily Hechtman, Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02142140     History of Changes
Other Study ID Numbers: MOP 123412
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Lily Hechtman, McGill University Health Center:
Treatment of ADHD
Long-term treatment follow-up

Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Methylphenidate
Lisdexamfetamine Dimesylate
Adderall
Dextroamphetamine
Atomoxetine Hydrochloride
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents