BLOOM: Boldly Living outdOOrs for Mental Health

NCT05973123 | Unknown

• 1 other identifier: 23-38315
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Anxiety; Pediatric Mental Health; Adverse Childhood Experiences

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Brief Resiliency Screen amongst children

  6 weeks

Other Outcomes (5)

• Change in hair cortisol levels in enrolled children

  6 weeks

• Change in BMI amongst enrolled children

  6 weeks

• Change in child's nature exposure as measured by GPS coordinates

  6 weeks

Study Arms (3)

BLOOM Group Outings

EXPERIMENTAL

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.

Behavioral: Group Nature Outings

BLOOM Independent Outings

EXPERIMENTAL

This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.

Behavioral: Family Outings

Control

NO INTERVENTION

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.

Interventions

Group Nature Outings BEHAVIORAL

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 Group Outings

Family Outings BEHAVIORAL

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.

BLOOM Independent Outings

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Benioff Children's Hospitals

Oakland, California, 94609, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Nooshin Razani, MD MPH

  UCSF and UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nooshin Razani, MD MPH

CONTACT

4155147877; nooshin.razani@ucsf.edu

Amaka Agodi, BS

CONTACT

4155147877; amaka.agodi@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 2, 2023
• Study Start: July 18, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)