Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series (AMPOCD)
Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues significant concurrent and long-term risk to affected youth. Although empirically supported psychosocial and pharmacological treatments for OCD exist, many children and their families are not able to adequately access these treatments or derive only partial benefit from them. Such findings highlight the importance of developing more effective treatment options which have the potential to be widely accessible to OCD youth.
The investigators are proposing to test a computerized attention modification program, AMP, in six youth with OCD in an open case series to gather information regarding protocol acceptability, feasibility and preliminary efficacy. This phase includes the development and refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP parameters for use with children.
Following ascertainment of study eligibility, participants will undergo a baseline assessment consisting of a clinical interview, neurocognitive assessments, EEG, attention bias assessment, and self report questionnaires. Study participants will then receive 12 sessions of AMP treatment over the course of three weeks. All youngsters and their families will be reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours over the course of six weeks. Participants who are treatment responders may be asked to return approximately 3 months after completing treatment for a follow-up assessment.
Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom severity.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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-
California
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Los Angeles、California、アメリカ、90024
- University of California Los Angeles
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Youth ages 8 - 17
- Primary DSM-IV diagnosis of OCD as determined by Anxiety Disorders Interview Schedule (ADIS-IV) Child/Parent version
- Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) score > 15
- Medication free or on stable medication for six weeks prior to study entry
- Informed parental consent and child assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.
Exclusion Criteria:
- DSM-IV depressive disorder, bipolar disorder, PTSD, substance abuse/dependence, conduct disorder, PDD, schizophrenia, or mental retardation
- Concurrent psychosocial treatment for OCD
- IQ < 80
- Youngsters with other comorbid disorders (e.g., anxiety, ADHD, ODD, tic disorder) will be eligible as long as these disorders are secondary to OCD in terms of severity and impairment and do not require immediate treatment initiation.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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：Attention Modification Program
|
Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.
他の名前：
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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 |
時間枠 |
|---|---|
|
Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment
時間枠：pre-treatment (week 0) and post-treatment (week 5)
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pre-treatment (week 0) and post-treatment (week 5)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment
時間枠：pre-treatment (week 0) and post-treatment (week 5)
|
pre-treatment (week 0) and post-treatment (week 5)
|
|
|
Attention Bias Assessment Change from Pre-Treatment to Post-Treatment
時間枠：pre-treatment (week 0) and post-treatment (week 5)
|
Computerized assessment of attention bias
|
pre-treatment (week 0) and post-treatment (week 5)
|
協力者と研究者
捜査官
- 主任研究者：Susanna Chang, PhD、University of California, Los Angeles
- 主任研究者：John Piacentini, PhD、University of California, Los Angeles
- 主任研究者：James McCraken, MD、University of California, Los Angeles
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。