- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Maine
-
Porter, Maine, Förenta staterna, 04068
- Maine Teen Camp
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Attendance of Maine Teen Camp sessions during summer months of 2024 and 2025.
Exclusion Criteria:
- None
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Attendance of a residential device-free summer camp in Maine for 2-3.5 weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Mental Health Quotient (MHQ) at End of Camp
Tidsram: 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Ratings of 47 MHQ Items After Camp Attendance
Tidsram: Baseline (Day 1) to end of camp attendance (up to 3.5 weeks).
|
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.
|
Baseline (Day 1) to end of camp attendance (up to 3.5 weeks).
|
|
Change from Baseline in Resting-State Electroencephalography (EEG) measures
Tidsram: 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.
|
Baseline (Day 1 of camp) and Post-Intervention (Final day of camp - 2.5-3 weeks later)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tara Thiagarajan, PhD, Sapien Labs
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MTC_24_25
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
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