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.
調査の概要
状態
わからない
研究の種類
介入
入学 (予想される)
326
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Quebec
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Montreal、Quebec、カナダ、H4H 1R3
- Douglas Mental Health University Institute
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Montreal、Quebec、カナダ、H4A 3J1
- Montreal Children's Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6年～12年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
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.
他の名前：
|
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アクティブコンパレータ：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.
他の名前：
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) symptomatology (measured via Conners' Global Index - Parent and Teacher Version)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Twenty-four months after tailored treatment has ended - on medication
|
Twenty-four months after tailored treatment has ended - on medication
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
時間枠：At baseline - no medication
|
At baseline - no medication
|
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Academic achievement (measured via Wechsler Individual Achievement Test (WIAT))
時間枠：At baseline - no medication
|
At baseline - no medication
|
|
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Emotional and symptomatic functioning (measured via the Achenbach Child Behavior Check List (CBCL))
時間枠：At baseline - no medication
|
At baseline - no medication
|
|
|
Overall functioning (measured via the Weiss Functional Impairment Scale (WFIRS))
時間枠：At baseline - no medication
|
At baseline - no medication
|
|
|
Overall functioning (measured via the Clinical Global Impression Scale (CGI))
時間枠：Assessed at baseline
|
Assessed at baseline
|
|
|
Social skills (measured via Parent and Teacher Social Skills Rating Scale)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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))
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Ridha Joober, MD, PhD、Douglas Mental Health University Institute
- 主任研究者：Natalie Grizenko, MD, FRCPC、Douglas Mental Health University Institute
- 主任研究者：Lily Hechtman, MD, FRCPC、McGill University Health Centre/Research Institute of the McGill University Health Centre
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年12月1日
一次修了 (予想される)
2019年2月1日
研究の完了 (予想される)
2019年2月1日
試験登録日
最初に提出
2014年5月14日
QC基準を満たした最初の提出物
2014年5月16日
最初の投稿 (見積もり)
2014年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2018年8月28日
QC基準を満たした最後の更新が送信されました
2018年8月27日
最終確認日
2018年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MOP 123412
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Academic and Organization skillsの臨床試験
-
Queens College, The City University of New York完了