AnxietyBLOOMNCT05973123
BLOOM: Boldly Living outdOOrs for Mental Health
A study testing Group Nature Outings and Family Outings in people with Anxiety and Stress Disorder, Posttraumatic, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress Disorder, Posttraumatic, Loneliness
- What is being tested?
- Group Nature Outings and Family Outings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Benioff Children's Hospitals
Oakland, California, 94609
About this study
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.
- Being tested
- Group Nature Outings, Family Outings
- Keywords
- Anxiety, Pediatric Mental Health, Adverse Childhood Experiences
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Nature OutingsBehavioural
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.
Family OutingsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Change in Brief Resiliency Screen amongst children
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start18 Jul 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Why it stopped: Study was withdrawn because available funding ended and could not be extended. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nooshin Razani, MD MPH, Principal investigator, UCSF and UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973123
- Sponsor's protocol ID
- 23-38315
- Acronym
- BLOOM
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLOOM: Boldly Living outdOOrs for Mental Health
- ClinicalTrials.gov ID
- NCT05973123
- Acronym / sponsor ID
- BLOOM / 23-38315
- Keywords
- Anxiety, Pediatric Mental Health, Adverse Childhood Experiences
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn because available funding ended and could not be extended. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 18 Jul 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLOOM Group Outings | Experimental | Behavioral: Group Nature Outings6 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 | Experimental | Behavioral: Family OutingsThis group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety. |
| 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. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Nature OutingsA 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. | Behavioural | BLOOM Group Outings |
| Family Outings6 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. | Behavioural | BLOOM Independent Outings |
Primary outcome
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.
1 secondary outcome
Change in Brief Resiliency Screen amongst children
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nooshin Razani, MD MPH principal investigator
UCSF and UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Nature Outings and Family Outings in people with Anxiety and Stress Disorder, Posttraumatic, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.