BLOOM: Boldly Living outdOOrs for Mental Health

Anxiety Clinical Trial

— BLOOM  

Official title:

BLOOM: Boldly Living outdOOrs for Mental Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973123
• Other study ID #: 23-38315
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Nooshin Razani, MD MPH
• Phone: 4155147877
• Email: nooshin.razani[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Pediatric Inclusion Criteria:

1. Age 9-12 years at enrollment

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 Child:

1. Concomitant active treatment modification (eg medication changes) for the past month.

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.

Exclusion criteria - caregiver

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.

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Anxiety
• Loneliness
• Stress Disorder, Posttraumatic
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospitals	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in hair cortisol levels in enrolled children	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.	6 weeks
Other	Change in BMI amongst enrolled children	Weight and height measurements will be obtained at baseline and at 6 weeks.	6 weeks
Other	Change in child's nature exposure as measured by GPS coordinates	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.	6 weeks
Other	Change in caregiver stress as measured by the Perceived Stress Score (PSS-10)	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.	6 weeks
Other	Changes in caregiver nature exposure as measured by NatureDose app	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.	6 weeks
Primary	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.	6 weeks
Secondary	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.	6 weeks