Follow up Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
2018年8月27日 更新者：Lily Hechtman、McGill University Health Centre/Research Institute of the McGill University Health Centre
Efficacy of Careful Medication and Tailored Case Management Follow up Treatment for Children With Attention Deficit Hyperactivity Disorder
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.
研究概览
地位
未知
研究类型
介入性
注册 (预期的)
326
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Quebec
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Montreal、Quebec、加拿大、H4H 1R3
- Douglas Mental Health University Institute
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Montreal、Quebec、加拿大、H4A 3J1
- Montreal Children's Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6年 至 12年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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).
|
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.
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 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.
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.
其他名称：
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.
其他名称：
|
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有源比较器：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.
|
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.
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 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.
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.
其他名称：
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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
大体时间：At baseline - no medication
|
At baseline - no medication
|
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Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
大体时间：Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
大体时间：Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
大体时间：Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
大体时间：Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
大体时间：Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
大体时间：At baseline - no medication
|
At baseline - no medication
|
|
|
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
大体时间：At baseline - no medication
|
At baseline - no medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
大体时间：At baseline - no medication
|
At baseline - no medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
大体时间：At baseline - no medication
|
At baseline - no medication
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
大体时间：Assessed at baseline
|
Assessed at baseline
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
大体时间：Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
大体时间：Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
大体时间：Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
大体时间：Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
大体时间：Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
|
|
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
大体时间：Twelve month after tailored treatment has ended - on medication
|
Twelve month after tailored treatment has ended - on medication
|
|
|
Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
大体时间：Twenty-four months after tailored treatment has ended
|
Twenty-four months after tailored treatment has ended
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
大体时间：Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
大体时间：Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
大体时间：Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
大体时间：Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
|
Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
大体时间：Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
大体时间：Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
大体时间：Six months after tailored treatment ends - on medication
|
Six months after tailored treatment ends - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
大体时间：Twelve months after tailored treatment has ended - on medication
|
Twelve months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
大体时间：Eighteen months after tailored treatment has ended - on medication
|
Eighteen months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
大体时间：Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
大体时间：Following 3 months of tailored treatment (including medication)
|
Following 3 months of tailored treatment (including medication)
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
大体时间：Three months after tailored treatment ends - on medication
|
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))
大体时间：Six months after tailored treatment ends - on medication
|
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))
大体时间：Nine months after tailored treatment ends - on medication
|
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))
大体时间：Twelve months after tailored treatment ends - on medication
|
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))
大体时间：Fifteen months after tailored treatment ends - on medication
|
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))
大体时间：Eighteen months after tailored treatment ends - on medication
|
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))
大体时间：Twenty-one months after tailored treatment ends - on medication
|
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))
大体时间：Twenty-four months after tailored treatment ends - on medication
|
For participants randomized to the medication monitoring and tailored case management follow-up group.
|
Twenty-four months after tailored treatment ends - on medication
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ridha Joober, MD, PhD、Douglas Mental Health University Institute
- 首席研究员：Natalie Grizenko, MD, FRCPC、Douglas Mental Health University Institute
- 首席研究员：Lily Hechtman, MD, FRCPC、McGill University Health Centre/Research Institute of the McGill University Health Centre
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年12月1日
初级完成 (预期的)
2019年2月1日
研究完成 (预期的)
2019年2月1日
研究注册日期
首次提交
2014年5月14日
首先提交符合 QC 标准的
2014年5月16日
首次发布 (估计)
2014年5月20日
研究记录更新
最后更新发布 (实际的)
2018年8月28日
上次提交的符合 QC 标准的更新
2018年8月27日
最后验证
2018年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MOP 123412
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.