BLOOM: Boldly Living outdOOrs for Mental Health

Not Applicable

Recruiting

• Conditions: Adverse Childhood Experiences; Stress Disorder, Posttraumatic; Anxiety; Loneliness
• Interventions: Behavioral: Group Nature Outings; Behavioral: Family Outings

• Registration Number: NCT05973123
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-18
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-31
• Status Verified: 2023-08
• Study First Posted: 2023-08-02
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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.

Exclusion criteria - caregiver

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BLOOM Group Outings	Group Nature 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.
BLOOM Independent Outings	Family Outings	This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.

Primary Outcome Measures

Name	Time	Method
Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores	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 Outcome Measures

Name	Time	Method
Change in Brief Resiliency Screen amongst children	6 weeks	Pediatric 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.

Trial Locations

Locations (1)

UCSF Benioff Children's Hospitals; 🇺🇸 Oakland, California, United States