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

Study Overview
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Brief Summary
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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: standard community follow up 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.

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

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Behavioral: Academic and Organization skills
* Behavioral: Parent Training
* Behavioral: Social Skills Training
* Drug: Long-acting stimulant
* Drug: Long-acting stimulant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Monitoring & Case Management<br>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<br>* 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.<br>Behavioral: Parent Training<br>* 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.<br>Behavioral: Social Skills Training<br>* 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.<br>Drug: Long-acting stimulant<br>* 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.<br>* Other names: Dexedrine;|
| Active Comparator: Community Follow-up Group<br>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<br>* 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.<br>Behavioral: Parent Training<br>* 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.<br>Behavioral: Social Skills Training<br>* 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.<br>Drug: Long-acting stimulant<br>* 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.<br>* Other names: Dexedrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of ADHD, Long-term treatment follow-up