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Clinical Trials/NCT05973123
NCT05973123
Recruiting
Not Applicable

BLOOM: Boldly Living outdOOrs for Mental Health

University of California, San Francisco1 site in 1 country126 target enrollmentJuly 18, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of California, San Francisco
Enrollment
126
Locations
1
Primary Endpoint
Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 18, 2023
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores

Time Frame: 6 weeks

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.

Secondary Outcomes

  • Change in Brief Resiliency Screen amongst children(6 weeks)

Study Sites (1)

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