RECRUITING

BLOOM: Boldly Living outdOOrs for Mental Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

BLOOM: Boldly Living outdOOrs for Mental Health

Quick Facts

Study Start:2023-07-18
Study Completion:2023-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05973123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Age 9-12 years at enrollment
  2. 2. Has an ACE Score of 1 or higher
  3. 3. Has a SCARED-P score of 15 or higher
  4. 4. Is available to attend three group outings if assigned to group intervention arm.
  5. 5. Has a caregiver who is able to consent and attend outings with them.
  6. 6. Is able to read, write, and speak English, Spanish or Arabic.
  7. 7. Has no serious health conditions that affect their ability to be in nature.
  8. 8. Willing to wear a provided electronic sensor continuously for 6 weeks, including sleep, excluding bathing and device recharging time.
  9. 9. Have no major changes in their mental health treatment plan during the time of the study.
  10. 1. Able to read, write and speak English, Spanish or Arabic
  11. 2. Be at least 18 years old.
  12. 3. Have no serious health conditions that affect their ability to be in nature.
  13. 4. Is available to attend 6 weekly outings if assigned to group intervention arm.
  14. 5. Have a smart phone and be willing to download NatureDose app from NatureQuant.
  15. 1. Concomitant active treatment modification (eg medication changes) for the past month.
  16. 2. Unable to attend weekly nature outings if randomized to the group intervention.
  17. 3. Physical or health limitation to participating in outdoor activities.
  18. 4. Previous SHINE participant.
  19. 5. Caregiver unable to consent.
  20. 6. Unable to pass short quiz at the end of the assent.
  21. 7. Wards of the state who do not have a guardian other than the state who can consent on their behalf.
  22. 8. Non-English, Arabic or Spanish speaking participants.
  23. 9. Unwilling to use a FitBit.
  24. 1. Unable to attend weekly nature outings if randomized to the group intervention.
  25. 2. Physical or health limitation to participating in outdoor activities.
  26. 3. Previous SHINE participant.
  27. 4. Unable to provide informed consent.
  28. 5. Non-English, Arabic or Spanish speaking participants.
  29. 6. Unwilling to use NatureDose app.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Nooshin Razani, MD MPH
CONTACT
4155147877
nooshin.razani@ucsf.edu
Amaka Agodi, BS
CONTACT
4155147877
amaka.agodi@ucsf.edu

Principal Investigator

Nooshin Razani, MD MPH
PRINCIPAL_INVESTIGATOR
UCSF and UCSF Benioff Children's Hospital Oakland

Study Locations (Sites)

UCSF Benioff Children's Hospitals
Oakland, California, 94609
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Nooshin Razani, MD MPH, PRINCIPAL_INVESTIGATOR, UCSF and UCSF Benioff Children's Hospital Oakland

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-18
Study Completion Date2023-09-30

Study Record Updates

Study Start Date2023-07-18
Study Completion Date2023-09-30

Terms related to this study

Keywords Provided by Researchers

  • Anxiety
  • Pediatric Mental Health
  • Adverse Childhood Experiences

Additional Relevant MeSH Terms

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