BLOOM: Boldly Living outdOOrs for Mental Health

NCT ID: NCT05973123

Last Updated: 2023-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-18

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Stress Disorder, Posttraumatic Loneliness Adverse Childhood Experiences

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BLOOM Group Outings

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.

Group Type EXPERIMENTAL

Group Nature Outings

Intervention Type 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 Independent Outings

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

Group Type EXPERIMENTAL

Family Outings

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.


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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nooshin Razani, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UCSF and UCSF Benioff Children's Hospital Oakland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCSF Benioff Children's Hospitals

Oakland, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nooshin Razani, MD MPH

Role: CONTACT

4155147877

Amaka Agodi, BS

Role: CONTACT

4155147877

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nooshin Razani, MD MPH

Role: primary

415-514-7877

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-38315

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Longitudinal Well-Being Study
NCT06668532 NOT_YET_RECRUITING NA
Study of Student Flourishing
NCT07259746 RECRUITING NA