Clinical trial NCT05973123: BLOOM: Boldly Living outdOOrs for Mental Health
Official title: BLOOM: Boldly Living outdOOrs for Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Stress Disorder, Posttraumatic
Loneliness
Adverse Childhood Experiences
Keywords: Anxiety
Pediatric Mental Health
Adverse Childhood Experiences
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 126
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Brief Resiliency Screen amongst children
timeFrame: 6 weeks
Other outcomes:
measure: Change in hair cortisol levels in enrolled children
timeFrame: 6 weeks
measure: Change in BMI amongst enrolled children
timeFrame: 6 weeks
measure: Change in child's nature exposure as measured by GPS coordinates
timeFrame: 6 weeks
measure: Change in caregiver stress as measured by the Perceived Stress Score (PSS-10)
timeFrame: 6 weeks
measure: Changes in caregiver nature exposure as measured by NatureDose app
timeFrame: 6 weeks
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospitals
state: California
Study officials:
affiliation: UCSF and UCSF Benioff Children's Hospital Oakland
name: Nooshin Razani, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: