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BLOOM: Boldly Living outdOOrs for Mental Health

BLOOM: Boldly Living outdOOrs for Mental Health

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05973123
Acronym
BLOOM
Enrollment
0
Registered
2023-08-02
Start date
2023-07-18
Completion date
2023-09-30
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences, Anxiety, Loneliness, Stress Disorder, Posttraumatic

Keywords

Anxiety, Pediatric Mental Health, Adverse Childhood Experiences

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.

Interventions

BEHAVIORALGroup 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.

BEHAVIORALFamily 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores6 weeksSCARED-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

MeasureTime frameDescription
Change in Brief Resiliency Screen amongst children6 weeksPediatric 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNooshin Razani, MD MPH

UCSF and UCSF Benioff Children's Hospital Oakland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026