- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07605975
Measuring and Enhancing Creativity and Brain Flexibility in Adolescents With Depression
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455
- University of Minnesota
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Child Depression Inventory 2 (CDI-2).
Lasso di tempo: Week 2
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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.
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Week 2
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Screen for Child Anxiety Related Disorders (SCARED)
Lasso di tempo: Month 3
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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.
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Month 3
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The Zest for Life Scale (ZLS)
Lasso di tempo: Week 1
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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.
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Week 1
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The Flourishing Scale
Lasso di tempo: Week 2
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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.
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Week 2
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The Satisfaction with Life Scale
Lasso di tempo: Week 2
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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.
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Week 2
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PSYCH-2021-30129
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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