Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
126 participants
INTERVENTIONAL
2023-07-18
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BLOOM Group Outings
6 weeks of nature based anxiety intervention for families with children who have at least one ACE and higher than average anxiety. Three of the outings will be group outings; the family will conduct 3 of the outings on their own independently.
Group Nature Outings
A 6 week nature-based intervention for pediatric anxiety. Every other week group outings for families in nature, alternating with every other week nature-based goals for families at home.
BLOOM Independent Outings
This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.
Family Outings
6 weeks of weekly outings into nature. These will be supported by the research team through a weekly text message and written materials on skill building and activities to do outdoors.
Control
Wait listed control. Receives standard of care referral to mental health resources on enrollment. At the end of study receives information on health benefits of being outdoors in nature and an invitation to group outings through the SHINE program at UCSF Benioff Children's Hospital Oakland.
No interventions assigned to this group
Interventions
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Group Nature Outings
A 6 week nature-based intervention for pediatric anxiety. Every other week group outings for families in nature, alternating with every other week nature-based goals for families at home.
Family Outings
6 weeks of weekly outings into nature. These will be supported by the research team through a weekly text message and written materials on skill building and activities to do outdoors.
Eligibility Criteria
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Inclusion Criteria
2. Has an ACE Score of 1 or higher
3. Has a SCARED-P score of 15 or higher
4. Is available to attend three group outings if assigned to group intervention arm.
5. Has a caregiver who is able to consent and attend outings with them.
6. Is able to read, write, and speak English, Spanish or Arabic.
7. Has no serious health conditions that affect their ability to be in nature.
8. Willing to wear a provided electronic sensor continuously for 6 weeks, including sleep, excluding bathing and device recharging time.
9. Have no major changes in their mental health treatment plan during the time of the study.
Caregiver eligibility criteria
1. Able to read, write and speak English, Spanish or Arabic
2. Be at least 18 years old.
3. Have no serious health conditions that affect their ability to be in nature.
4. Is available to attend 6 weekly outings if assigned to group intervention arm.
5. Have a smart phone and be willing to download NatureDose app from NatureQuant.
Exclusion Criteria
2. Unable to attend weekly nature outings if randomized to the group intervention.
3. Physical or health limitation to participating in outdoor activities.
4. Previous SHINE participant.
5. Caregiver unable to consent.
6. Unable to pass short quiz at the end of the assent.
7. Wards of the state who do not have a guardian other than the state who can consent on their behalf.
8. Non-English, Arabic or Spanish speaking participants.
9. Unwilling to use a FitBit.
1. Unable to attend weekly nature outings if randomized to the group intervention.
2. Physical or health limitation to participating in outdoor activities.
3. Previous SHINE participant.
4. Unable to provide informed consent.
5. Non-English, Arabic or Spanish speaking participants.
6. Unwilling to use NatureDose app.
9 Years
12 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Nooshin Razani, MD MPH
Role: PRINCIPAL_INVESTIGATOR
UCSF and UCSF Benioff Children's Hospital Oakland
Locations
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UCSF Benioff Children's Hospitals
Oakland, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-38315
Identifier Type: -
Identifier Source: org_study_id
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