Development of a Multi-faceted Cognitive Training Program for Children With Attention Deficit Hyperactivity Disorder (ADHD)
2017年6月19日 更新者:Children's Hospital Medical Center, Cincinnati
Development of a Multi-faceted Cognitive Training Program for Children With ADHD
After decades of Attention Deficit Hyperactivity Disorder (ADHD) intervention research, only two intervention approaches (i.e., psychopharmacology, behavioral treatment) have a "well-established" evidence-base supporting their efficacy for children with ADHD.
Both of these interventions have inherent limitations.
Recently multiple studies have demonstrated that cognitive training may improve neuropsychological and behavioral functioning in children with ADHD.
The magnitude of treatment effects for cognitive training has been comparable to treatment effects for behavioral treatment for ADHD (i.e., small to moderate effect sizes).
A limitation of existing cognitive training programs that may limit their efficacy is that each has employed a unifaceted approach.
Each intervention program has targeted a single cognitive domain (e.g., working memory).
This is problematic since as a group, children with ADHD have multiple areas of cognitive deficit (i.e., working memory, attention, response inhibition, delay aversion, intra-individual variability) and thus a unifaceted intervention does not address the multifaceted array of cognitive dysfunction in children with ADHD.
Also, because individuals with ADHD each have unique patterns of cognitive deficits, a unifaceted cognitive training approach may target areas which are non-deficient and miss areas of significant deficit in individual patients depending on their ideographic cognitive profile.
The primary goal of the proposed research is to develop and test a multifaceted cognitive training intervention that addresses a comprehensive array of ADHD-related cognitive deficits thereby ensuring that children's unique areas of cognitive deficit are targeted.
During Phase I (R21 grant), software and a manual will be developed consisting of four training tasks targeting response inhibition, verbal working memory, attention, and delay aversion.
Each task will possess advancing levels of difficulty.
On each task, children will receive feedback on performance accuracy as well as on intra-individual variability in reaction times.
The software will be pilot tested in Phase I to determine performance thresholds and intervention duration.
Also, focus groups will be conducted to obtain patient perceptions of each task's difficulty and interest level.
In Phase II (R33 grant), a preliminary randomized clinical trial will be conducted in order to obtain initial estimates of treatment efficacy.
Pre-, post-, and follow up outcomes will be collected on a wide range of neuropsychological, behavioral, and academic measures.
Effect size estimates across outcomes will be used to guide sample size determinations for future clinical trials of multifaceted cognitive training.
調査の概要
研究の種類
介入
入学 (実際)
44
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
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Ohio
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Cincinnati、Ohio、アメリカ、45229
- Cincinnati Childrens Hospital Medical Center
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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
7年~12年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Consent: The family must provide signature of informed consent by parents or legal guardians.
- Age at time of Screening: 7 to 12 years of age, inclusive.
- Gender: includes male and female children.
- ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD-PIT or ADHD-CT subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
- Cognitive Functioning: IQ of greater than 80 as estimated by the Wechsler Intelligence Scale for Children Fourth Edition.
- Learning Disability: Children must score 75 or above on two of the Wechsler Individual Achievement Test (WIAT) subtests (Reading & Numerical Operations).
- School: Children must be enrolled in a school setting from which teacher ratings can be obtained.
- History of Psychiatric Medications: Children may be taking psychiatric medications. However, they must present with significant ADHD inattention symptoms while on medication in order to be included in the study. We will ask that children on ADHD medications to refrain from altering the dosage for 10 weeks from study enrollment to after the immediate post-intervention follow-up. In order to screen for possible medication adjustments, all parents will be asked during the initial phone screen if their child is on an ADHD medication and if they anticipate a change in that medication dosage. If they answer that they anticipate a dosage change, they will be excluded from the study.
Exclusion Criteria:
- Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
- Exclusionary Psychiatric Conditions: Children who meet diagnostic criteria on the K-SADS for OCD, any psychotic disorder, major depressive disorder or bipolar disorder will be excluded from participation.
- Developmental Disabilities. Patients will be excluded if they are deemed to be significantly developmentally delayed or have a pervasive developmental disorder. Developmental delay will be operationally defined as an IQ score below 80. Children scoring 80 or above will be included. A semi-structured interview, the CAARTE, will be used to screen for autism.
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:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Multifaceted Cognitive Training
Cognitive Training with 4 different tasks each of which gets progressively more difficult as children obtain proficiency.
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Four computerized training tasks
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偽コンパレータ:Sham Cognitive Training
Cognitive Training with 4 different tasks which does not get progressively more difficult throughout training
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Four computerized training tasks
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale
時間枠:8 weeks
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Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0="Never"; 1="Occasionally"; 2="Often"; 3="Very often"); higher scores indicate higher severity of ADHD symptoms.
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8 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reaction Time Variability on go/No-go Task
時間枠:8 weeks
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Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task
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8 weeks
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Proportion of Words Read Accurately Using the AIMSWEB
時間枠:8 weeks
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Number of words read correctly divided by number of words read
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8 weeks
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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:Jeffery N Epstein, Ph.D.、Cincinnati Childrens Hospital Medical Center
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
2011年4月1日
一次修了 (実際)
2013年12月1日
研究の完了 (実際)
2016年6月1日
試験登録日
最初に提出
2011年3月24日
QC基準を満たした最初の提出物
2011年5月11日
最初の投稿 (見積もり)
2011年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2017年8月1日
QC基準を満たした最後の更新が送信されました
2017年6月19日
最終確認日
2017年6月1日
詳しくは
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