Measuring and Enhancing Creativity and Brain Flexibility in Adolescents With Depression
調査の概要
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
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- age 12-17 years
- Phase 1: no clinical diagnosis required.
- Phase 2: presence of at least "mild" depression symptoms as measured by a score of at least 12 on the parent-report Children's Depression Inventory (CDI) (completed in the screening form).
- Phase 2, Summer 2025 East African cohort: The adolescent identifies as East African.
- Phase 2, Summer 2025 Native American cohort: The adolescent identifies as Native American.
Exclusion Criteria:
- any MRI contraindications (e.g., claustrophobia, braces, pregnancy); Note: MRI exclusion is removed for Summer 2023 and 2025 cohorts since the neuroimaging has been removed from the protocol for those cohorts
- neurodevelopmental disorder such as intellectual disability or moderate / severe autism, as indicated by parent report;
- significant medical conditions that would interfere with participating in study activities;
- currently active suicidal ideation, and unable to agree to an appropriate safety plan
- history of significant neurological conditions that might confound MRI analyses (e.g., current and severe epilepsy, brain tumor). Note: this exclusion is removed for Summer 2023 and 2025 cohorts since they will not have MRI.
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：支持療法
- 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：Creativity Camp
All participants who enrolled in the study were assigned to the Creativity Camp. In Summer 2022, participants were 1:1 randomized to "early" (2 weeks before camp, before camp, after camp) or "late" assessments (before camp, after camp, and 2 weeks after camp). This allowed for an approximation of a waitlist-control design, where we compared the changes during the "waitlist" (the two weeks before camp for the "early" group) to the changes during camp for the "active" group (changes from pre to post intervention for the "late" group) and also allowed us to explore short-term durability of effects in the "late" group. In 2023 and 2025, since MRI was no longer required, clinical data were collected at all 4 time points: 2 weeks before, before camp, after camp, and 2 weeks after camp. This allows for analysis of the data using a "waitlist control" approach while not changing the experience at the level of the participant. |
An 8-day creativity camp that includes a variety of different kinds of creative arts activities.
|
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 |
|---|---|---|
|
Child Depression Inventory 2 (CDI-2).
時間枠：Week 2
|
The CDI (2) is a self-report questionnaire completed by child and parent separately.
The Child CDI 2 is a 28-item measure of depression symptoms for youth ages 7-17.
For each item, participants selected one of three choices that describe the severity of their symptoms over the past 2 weeks.
Responses are: 0 (no symptoms), 1 (mild or probable symptoms), or 2 (definite symptoms).
The 17-item Parent CDI 2, has four choices per item, ranging from 0 (not at all) to 3 (much or most of the time).
For both child and parent reports, higher scores mean more severe depression.
|
Week 2
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Screen for Child Anxiety Related Disorders (SCARED)
時間枠：Month 3
|
The SCARED is a 41-item inventory of anxiety symptoms rated on a 3-point Likert-type scale.
Higher scores mean higher severity of anxiety.
|
Month 3
|
|
The Zest for Life Scale (ZLS)
時間枠：Week 1
|
This 12-item questionnaire assesses engagement, enthusiasm, and positive outlook on life in the last week.
Each of the 12 items is rated on a 9-point Likert scale ranging from 0 (not at all) to 8 (very strongly).
The minimum possible score is 0, and the maximum is 96.
Higher scores on the scale indicate a greater zest for life.
|
Week 1
|
|
The Flourishing Scale
時間枠：Week 2
|
In this 8-item questionnaire, participants rate on a 1-7 scale their agreement with statements regarding perceptions of their life's meaning and purpose, view of self and how they fit into the world.
Maximum score is 56.
Higher scores mean higher levels of well-being.
|
Week 2
|
|
The Satisfaction with Life Scale
時間枠：Week 2
|
The Satisfaction with Life Scale assesses overall life satisfaction, with 5 questions on a 1-7 scale.
Maximum score is 35.
Higher scores mean higher life satisfaction.
|
Week 2
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。