- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07761143
Impact of Device Free Summer Camp on Adolescent Mental Health and Wellbeing
IMPACT OF DEVICE FREE SUMMER CAMP ON ADOLESCENT MENTAL HEALTH AND WELLBEING
The goal of this clinical trial is to understand if attendance of a device-free summer camp, representing a shift from a digital environment to one that is device free and involves in person social interaction, can change mental health status and brain physiology in teens age 12-17. The main question it aims to answer is:
- How much is aggregate mental health and its various dimensions and components changed at the end of the camp attendance relative to the start of camp.
- How much is brain physiology, as measured by EEG change, changed at the end of camp relative to the start of camp.
Participants are recruited from among teens signed up to attend 2 or 3.5 week sessions a summer camp in Maine.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The goal of this clinical trial is to understand if attendance of a device-free summer camp, representing a shift from a digital environment to one that is device free and involves in person social interaction, can change mental health status and brain physiology in teens age 12-17. The main question it aims to answer is:
- How much is aggregate mental health and its various dimensions and components changed at the end of the camp attendance relative to the start of camp.
- How much is brain physiology, as measured by EEG change, changed at the end of camp relative to the start of camp.
Participants are recruited from among teens signed up to attend 2 or 3.5 week sessions a summer camp in Maine. Participants were asked to complete the MHQ, a comprehensive mental health assessment spanning 47 emotional, social and cognitive aspects and on the first day of camp and then again on the day before departure. In addition participants were asked questions on their school and camp experiences at the start and end of camp respectively.
Participants were also invited to participate in a socio-emotional task and/or have EEG measurements read on the first day of camp and the day before departure form camp. The socio-emotional task involved speaking or performing in front of a group of 4 or 5 people and rating one's own feelings performing this task as well as rating the perceived feelings of other group members when they were performing the task.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maine
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Porter, Maine, Estados Unidos, 04068
- Maine Teen Camp
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Attendance of Maine Teen Camp sessions during summer months of 2024 and 2025.
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Maine Teen Camp attendees
Attendance of a residential device-free summer camp for teens for 2 to 3.5 weeks characterized by in-person interaction and nature rich outdoor activities.
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Attendance of a residential device-free summer camp in Maine for 2-3.5 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Mental Health Quotient (MHQ) at End of Camp
Periodo de tiempo: Baseline (Day 1) to end of camp attendance (up to 3.5 weeks).
|
The Mental Health Quotient or MHQ is an aggregate score of mental health computed from the 47 items of the MHQ assessment.
The score ranges from -100 to +200, where higher scores indicate better mental health outcomes.
Negative scores indicate significant symptoms that impact function (Distressed/Struggling range), while positive scores reflect the wide range of normal function (Enduring to Thriving).
Change is calculated by subtracting the baseline score from the end of camp score.
|
Baseline (Day 1) to end of camp attendance (up to 3.5 weeks).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Ratings of 47 MHQ Items After Camp Attendance
Periodo de tiempo: Baseline (Day 1) to end of camp attendance (up to 3.5 weeks).
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Difference in the ratings of each of the 47 items in the MHQ assessment spanning emotional, social, cognitive and physical capacities and problems.
Participants rate each item on a 9-point life impact scale.
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Baseline (Day 1) to end of camp attendance (up to 3.5 weeks).
|
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Change from Baseline in Resting-State Electroencephalography (EEG) measures
Periodo de tiempo: Baseline (Day 1 of camp) and Post-Intervention (Final day of camp - 2.5-3 weeks later)
|
The outcome measure evaluates changes in EEG spectral metrics such as spectral slope, spectral bands and time domain metrics such as complexity/entropy measures such as Detrending Fluctuation Analysis (DFA), Lempel-Ziv Complexity and Sample Entropy measured during 3 minutes of EEG with eyes closed at the start and end of the camp session.
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Baseline (Day 1 of camp) and Post-Intervention (Final day of camp - 2.5-3 weeks later)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tara Thiagarajan, PhD, Sapien Labs
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
- MTC_24_25
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
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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