- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07605975
Measuring and Enhancing Creativity and Brain Flexibility in Adolescents With Depression
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Child Depression Inventory 2 (CDI-2).
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Screen for Child Anxiety Related Disorders (SCARED)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PSYCH-2021-30129
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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