Back to resultsBLOOM: Boldly Living outdOOrs for Mental Health (BLOOM)
Primary Purpose
Anxiety, Stress Disorder, Posttraumatic, Loneliness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Nature Outings
Family Outings
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Pediatric Mental Health, Adverse Childhood Experiences
Eligibility Criteria
Pediatric Inclusion Criteria: Age 9-12 years at enrollment Has an ACE Score of 1 or higher Has a SCARED-P score of 15 or higher Is available to attend three group outings if assigned to group intervention arm. Has a caregiver who is able to consent and attend outings with them. Is able to read, write, and speak English, Spanish or Arabic. Has no serious health conditions that affect their ability to be in nature. Willing to wear a provided electronic sensor continuously for 6 weeks, including sleep, excluding bathing and device recharging time. Have no major changes in their mental health treatment plan during the time of the study. Caregiver eligibility criteria Able to read, write and speak English, Spanish or Arabic Be at least 18 years old. Have no serious health conditions that affect their ability to be in nature. Is available to attend 6 weekly outings if assigned to group intervention arm. Have a smart phone and be willing to download NatureDose app from NatureQuant. Exclusion Criteria Child: Concomitant active treatment modification (eg medication changes) for the past month. Unable to attend weekly nature outings if randomized to the group intervention. Physical or health limitation to participating in outdoor activities. Previous SHINE participant. Caregiver unable to consent. Unable to pass short quiz at the end of the assent. Wards of the state who do not have a guardian other than the state who can consent on their behalf. Non-English, Arabic or Spanish speaking participants. Unwilling to use a FitBit. Exclusion criteria - caregiver Unable to attend weekly nature outings if randomized to the group intervention. Physical or health limitation to participating in outdoor activities. Previous SHINE participant. Unable to provide informed consent. Non-English, Arabic or Spanish speaking participants. Unwilling to use NatureDose app.
Sites / Locations
- UCSF Benioff Children's HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
BLOOM Group Outings
BLOOM Independent Outings
Control
Arm Description
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.
This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.
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.
Outcomes
Primary Outcome Measures
Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores
SCARED-P is a measure widely used to assess childhood anxiety. Caregivers will rate pediatric anxiety by taking the SCARED-P assessment, which consists of 41 items that assess a child's recent anxiety symptoms. Participants respond on a 3-point Likert scale of 0 (Not True or Hardly Ever True), 1 (Somewhat or Sometimes True), or 2 (Very True or Often True). Higher scores indicate a higher preponderance of clinically significant anxiety.
Secondary Outcome Measures
Change in Brief Resiliency Screen amongst children
Pediatric resilience will be measured, at baseline and at 6 weeks by surveying children directly using the Brief Resiliency Scale. In their systematic review, Windle et al. reviewed 2,979 papers and identified 15 potential scales to measure resiliency in children and adults. Of these, the Brief Resiliency Scale is the only one which had an acceptable Cronbach's alpha (>0.70 and < 0.95 across four different samples), had acceptable criterion validity as it was correlated with Connor-Davidson Resilience Scale and Ego Resiliency Scale. Questions are answered using a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Three questions were reverse-scored such that a higher number was associated with greater resilience.
Full Information
NCT ID
NCT05973123
First Posted
July 24, 2023
Last Updated
August 24, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05973123
Brief Title
BLOOM: Boldly Living outdOOrs for Mental Health
Acronym
BLOOM
Official Title
BLOOM: Boldly Living outdOOrs for Mental Health
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In 2019, the Office of the California Surgeon General launched the ACEs Aware Initiative in collaboration with the California Department of Health Care Services. This ambitious campaign aims to develop a network of care model of healthcare delivery that explicitly links health resources within communities to clinicians screening patients for ACEs. The ACEs Aware Initiative recognizes nature experiences as one of seven "stress busters." Indeed, California boasts many outdoor resources for clinicians to integrate into the network of care. Through a calming effect on the autonomic nervous system, providing a setting for supportive relationships to develop and physical activity to occur, time in nature may help California prevent, heal and treat ACEs and the clinical sequelae. As one of the most common psychiatric disorders in youth, anxiety remains one of the most important sequelae of ACEs. There is a gap in evidence evaluating nature-based programs for child mental health. This study will evaluate BLOOM [Boldly Living outdOOrs for Mental health], a new intervention which is a modified version of an existing nature-based curriculum called SHINE (Stay Healthy In Nature Everyday) curriculum currently in place at UCSF Benioff Children's Hospital Oakland, which takes youth and their families into nature once a month for stress relief. This new intervention mirrors SHINE except that it will be tailored to children ages 9-12 with a history of ACEs and current anxiety. This study will evaluate the benefits of a group intervention model, an independent nature-outing model, and a comparison to a wait-listed control group. Our goal is to provide a scalable model for low-cost mental health care to the California Department of Health Care Services.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress Disorder, Posttraumatic, Loneliness, Adverse Childhood Experiences
Keywords
Anxiety, Pediatric Mental Health, Adverse Childhood Experiences
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BLOOM Group Outings
Arm Type
Experimental
Arm Description
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.
Arm Title
BLOOM Independent Outings
Arm Type
Experimental
Arm Description
This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Nature Outings
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Outings
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores
Description
SCARED-P is a measure widely used to assess childhood anxiety. Caregivers will rate pediatric anxiety by taking the SCARED-P assessment, which consists of 41 items that assess a child's recent anxiety symptoms. Participants respond on a 3-point Likert scale of 0 (Not True or Hardly Ever True), 1 (Somewhat or Sometimes True), or 2 (Very True or Often True). Higher scores indicate a higher preponderance of clinically significant anxiety.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Brief Resiliency Screen amongst children
Description
Pediatric resilience will be measured, at baseline and at 6 weeks by surveying children directly using the Brief Resiliency Scale. In their systematic review, Windle et al. reviewed 2,979 papers and identified 15 potential scales to measure resiliency in children and adults. Of these, the Brief Resiliency Scale is the only one which had an acceptable Cronbach's alpha (>0.70 and < 0.95 across four different samples), had acceptable criterion validity as it was correlated with Connor-Davidson Resilience Scale and Ego Resiliency Scale. Questions are answered using a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Three questions were reverse-scored such that a higher number was associated with greater resilience.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Change in hair cortisol levels in enrolled children
Description
Hair Cortisol levels will be measured at baseline and at 6 weeks for participants who opt into the section of the study. Hair cortisol is a marker of stress over the previous month. Hair cortisol and cortisone levels will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Samples of hair (5mg, 40-50 stands, 2 cm long) will be obtained from the back of the scalp for consenting child participants.
Time Frame
6 weeks
Title
Change in BMI amongst enrolled children
Description
Weight and height measurements will be obtained at baseline and at 6 weeks.
Time Frame
6 weeks
Title
Change in child's nature exposure as measured by GPS coordinates
Description
Enrolled children will be asked to wear a FitBit during the course of the study. The FitBit will record the patients GPS coordinates during the course of the 6 weeks of the study. The GPS coordinates will be submitted to the NatureQuant organization without any identifying data. Using satellite and GIS data, NatureQuant will give the research team information about how much vegetation the child was around, and how many parks they visited during the 6 weeks of the study.
Time Frame
6 weeks
Title
Change in caregiver stress as measured by the Perceived Stress Score (PSS-10)
Description
Caregivers will fill out the PSS10, a 10-item validated Likert scale, with responses to each item with five options (i.e., never, almost never, sometimes, usually, always). They will fill this out at baseline and at six weeks. A higher score corresponds with higher stress.
Time Frame
6 weeks
Title
Changes in caregiver nature exposure as measured by NatureDose app
Description
Enrolled caregivers will be instructed on how to download the NatureDose app on their phones. They will register on the app using a unique research identifier code which does not have personal identifying data on it. The NatureDose app will follow the participant's gps coordinates during the course of the study in order to provide the research team with information about exposure to vegetation and park visits during the six week course fo this clinical trial.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Pediatric Inclusion Criteria:
Age 9-12 years at enrollment
Has an ACE Score of 1 or higher
Has a SCARED-P score of 15 or higher
Is available to attend three group outings if assigned to group intervention arm.
Has a caregiver who is able to consent and attend outings with them.
Is able to read, write, and speak English, Spanish or Arabic.
Has no serious health conditions that affect their ability to be in nature.
Willing to wear a provided electronic sensor continuously for 6 weeks, including sleep, excluding bathing and device recharging time.
Have no major changes in their mental health treatment plan during the time of the study.
Caregiver eligibility criteria
Able to read, write and speak English, Spanish or Arabic
Be at least 18 years old.
Have no serious health conditions that affect their ability to be in nature.
Is available to attend 6 weekly outings if assigned to group intervention arm.
Have a smart phone and be willing to download NatureDose app from NatureQuant.
Exclusion Criteria Child:
Concomitant active treatment modification (eg medication changes) for the past month.
Unable to attend weekly nature outings if randomized to the group intervention.
Physical or health limitation to participating in outdoor activities.
Previous SHINE participant.
Caregiver unable to consent.
Unable to pass short quiz at the end of the assent.
Wards of the state who do not have a guardian other than the state who can consent on their behalf.
Non-English, Arabic or Spanish speaking participants.
Unwilling to use a FitBit.
Exclusion criteria - caregiver
Unable to attend weekly nature outings if randomized to the group intervention.
Physical or health limitation to participating in outdoor activities.
Previous SHINE participant.
Unable to provide informed consent.
Non-English, Arabic or Spanish speaking participants.
Unwilling to use NatureDose app.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nooshin Razani, MD MPH
Phone
4155147877
Email
nooshin.razani@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amaka Agodi, BS
Phone
4155147877
Email
amaka.agodi@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nooshin Razani, MD MPH
Organizational Affiliation
UCSF and UCSF Benioff Children's Hospital Oakland
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Benioff Children's Hospitals
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nooshin Razani, MD MPH
Phone
415-514-7877
Email
nooshin.razani@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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