Computer-Aided Learning for Managing Stress (CALMS)
A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
調査の概要
詳細な説明
CALMS revolves around the use of Emotional Manipulatives (EM) developed at Boston Children's Hospital (BCH). EM are single and multi-user biofeedback games designed to enhance executive control of emotion. The intervention and EM in CALMS were adapted from those used in Anger Control Training (ACT) with Regulate and Gain Emotional Control (RAGE-Control). In a randomized controlled trial at BCH, ACT and RAGE-Control relative to "sham" video-game play without biofeedback led to significantly greater reductions of aggression in adolescents and greater improvement in family functioning.
In this feasibility study, family dyads will participate in 12 sessions aimed at
- enhancing engagement through the use of video and other games,
- enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and
- harnessing the power of the family to enhance contextual learning and the generality and duration of effects.
Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Beth Israel Deaconess Medical Center
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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:
- Currently Meet or Have Met Criteria of Prodromal Syndromes (COPS) according to the SIPS within the past 2 years
- Estimated IQ > 70
- Speak fluent English
- Have at least one parent or adult family member who also speaks fluent English and is willing to participate
Exclusion Criteria:
- Physical limitations precluding effective use of biofeedback videogames
- Co-morbid psychiatric disorders, including substance disorders, but only if they better explain COPS symptoms or make participation counter-indicated.
- Active suicidal ideation or attempts within the past 2 months unless being actively monitored and treated for this by a clinician
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:CALMS
12 session family therapy using multi-user biofeedback games
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Family Therapy; Multi-user Biofeedback Videogames
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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 |
---|---|---|
Feasibility: Percent of referred who consent and meet study criteria
時間枠:Up to six months
|
Enrollment
|
Up to six months
|
Feasibility: Percent of 12 sessions completed
時間枠:Up to six months
|
Engagement: Percent of sessions completed by consented and eligible participants
|
Up to six months
|
Feasibility: Counts of premature termination of intervention
時間枠:Up to six months
|
Up to six months
|
|
Feasibility: Self-report of Credibility/Satisfaction
時間枠:12 week assessment or last assessment completed
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Individual and family member self-report
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12 week assessment or last assessment completed
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Feasibility: Self-report of User Experience
時間枠:12 week assessment or last assessment completed
|
Self-report of ability to learn/use technology to lower stress reactivity
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12 week assessment or last assessment completed
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Perceived Stress relative to Baseline
時間枠:Weeks 4, 8, and 12 Assessments
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Self-report via Perceived Stress Scale
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Weeks 4, 8, and 12 Assessments
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Change relative to Baseline in Youth Perceptions of Relationship with Family Member
時間枠:Weeks 4, 8, 12 Assessments
|
Self-report of conflict, criticism, and warmth in relationship with participating family member
|
Weeks 4, 8, 12 Assessments
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Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult
時間枠:Weeks 4, 8, 12 Assessments
|
Self-report of conflict, criticism, and warmth in relationship with youth
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Weeks 4, 8, 12 Assessments
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Positive Symptom Score Change relative to Baseline
時間枠:Weeks 4,8, and 12 Assessments
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Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)
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Weeks 4,8, and 12 Assessments
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Change in Social and Role Functioning relative to Baseline
時間枠:Weeks 4, 8, and 12 Assessments
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Global Functioning: Social & Role Scales;
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Weeks 4, 8, and 12 Assessments
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Change in Global Functioning relative to Baseline
時間枠:Weeks 4, 8, and 12 Assessments
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SIPS Global Assessment of Functioning
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Weeks 4, 8, and 12 Assessments
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Safety: Change in Hostility/Aggression relative to Baseline
時間枠:Weeks 4, 8, and 12
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Self-report
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Weeks 4, 8, and 12
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Safety: Change in Video-game Addiction relative to Baseline
時間枠:Weeks 4, 8, and 12
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Self-report
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Weeks 4, 8, and 12
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Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task
時間枠:Baseline, Weeks 4,8, and 12
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Executive Control of Emotion
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Baseline, Weeks 4,8, and 12
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協力者と研究者
捜査官
- 主任研究者:Kristen Woodberry, MSW, Ph.D.、Beth Israel Deaconess Medical Center
出版物と役立つリンク
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 (実際)
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
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