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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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The purpose of the study is to examine how well two types of treatment follow up work compared to one another:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication Monitoring & Case Management | Experimental | 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). |
|
| Community Follow-up Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Academic and Organization skills | Behavioral | 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. |
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lily Hechtman, MD, FRCPC | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Natalie Grizenko, MD, FRCPC | Douglas Mental Health University Institute | Principal Investigator |
| Ridha Joober, MD, PhD | Douglas Mental Health University Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Children's Hospital | Montreal | Quebec | H4A 3J1 | Canada | ||
| Douglas Mental Health University Institute |
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| Parent Training | Behavioral | 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. |
|
| Social Skills Training | Behavioral | 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. |
|
| Long-acting stimulant | Drug | 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. |
|
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| Long-acting stimulant | Drug | 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. |
|
|
| 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 |
| Montreal |
| Quebec |
| H4H 1R3 |
| Canada |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| D008774 | Methylphenidate |
| D000069478 | Lisdexamfetamine Dimesylate |
| C090411 | Adderall |
| D003913 | Dextroamphetamine |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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