xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05973123</url>
    </required_header>
    <id_info>
      <org_study_id>23-38315</org_study_id>
      <nct_id>NCT05973123</nct_id>
    </id_info>
    <brief_title>BLOOM: Boldly Living outdOOrs for Mental Health</brief_title>
    <acronym>BLOOM</acronym>
    <official_title>BLOOM: Boldly Living outdOOrs for Mental Health</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Francisco</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In 2019, the Office of the California Surgeon General launched the ACEs Aware Initiative in&#xD;
        collaboration with the California Department of Health Care Services. This ambitious campaign&#xD;
        aims to develop a network of care model of healthcare delivery that explicitly links health&#xD;
        resources within communities to clinicians screening patients for ACEs. The ACEs Aware&#xD;
        Initiative recognizes nature experiences as one of seven &quot;stress busters.&quot; Indeed, California&#xD;
        boasts many outdoor resources for clinicians to integrate into the network of care. Through a&#xD;
        calming effect on the autonomic nervous system, providing a setting for supportive&#xD;
        relationships to develop and physical activity to occur, time in nature may help California&#xD;
        prevent, heal and treat ACEs and the clinical sequelae. As one of the most common psychiatric&#xD;
        disorders in youth, anxiety remains one of the most important sequelae of ACEs. There is a&#xD;
        gap in evidence evaluating nature-based programs for child mental health. This study will&#xD;
        evaluate BLOOM [Boldly Living outdOOrs for Mental health], a new intervention which is a&#xD;
        modified version of an existing nature-based curriculum called SHINE (Stay Healthy In Nature&#xD;
        Everyday) curriculum currently in place at UCSF Benioff Children's Hospital Oakland, which&#xD;
        takes youth and their families into nature once a month for stress relief. This new&#xD;
        intervention mirrors SHINE except that it will be tailored to children ages 9-12 with a&#xD;
        history of ACEs and current anxiety. This study will evaluate the benefits of a group&#xD;
        intervention model, an independent nature-outing model, and a comparison to a wait-listed&#xD;
        control group. Our goal is to provide a scalable model for low-cost mental health care to the&#xD;
        California Department of Health Care Services.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores</measure>
      <time_frame>6 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Brief Resiliency Screen amongst children</measure>
      <time_frame>6 weeks</time_frame>
      <description>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 (&gt;0.70 and &lt; 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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in hair cortisol levels in enrolled children</measure>
      <time_frame>6 weeks</time_frame>
      <description>Hair Cortisol levels will be measured at baseline and at 6 weeks for participants who opt into the section of the study. Hair cortisol is a marker of stress over the previous month. Hair cortisol and cortisone levels will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Samples of hair (5mg, 40-50 stands, 2 cm long) will be obtained from the back of the scalp for consenting child participants.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in BMI amongst enrolled children</measure>
      <time_frame>6 weeks</time_frame>
      <description>Weight and height measurements will be obtained at baseline and at 6 weeks.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in child's nature exposure as measured by GPS coordinates</measure>
      <time_frame>6 weeks</time_frame>
      <description>Enrolled children will be asked to wear a FitBit during the course of the study. The FitBit will record the patients GPS coordinates during the course of the 6 weeks of the study. The GPS coordinates will be submitted to the NatureQuant organization without any identifying data. Using satellite and GIS data, NatureQuant will give the research team information about how much vegetation the child was around, and how many parks they visited during the 6 weeks of the study.</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in caregiver stress as measured by the Perceived Stress Score (PSS-10)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Caregivers will fill out the PSS10, a 10-item validated Likert scale, with responses to each item with five options (i.e., never, almost never, sometimes, usually, always). They will fill this out at baseline and at six weeks. A higher score corresponds with higher stress.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in caregiver nature exposure as measured by NatureDose app</measure>
      <time_frame>6 weeks</time_frame>
      <description>Enrolled caregivers will be instructed on how to download the NatureDose app on their phones. They will register on the app using a unique research identifier code which does not have personal identifying data on it. The NatureDose app will follow the participant's gps coordinates during the course of the study in order to provide the research team with information about exposure to vegetation and park visits during the six week course fo this clinical trial.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>Anxiety</condition>
    <condition>Stress Disorder, Posttraumatic</condition>
    <condition>Loneliness</condition>
    <condition>Adverse Childhood Experiences</condition>
    <arm_group>
      <arm_group_label>BLOOM Group Outings</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BLOOM Independent Outings</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Group Nature Outings</intervention_name>
      <description>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.</description>
      <arm_group_label>BLOOM Group Outings</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Family Outings</intervention_name>
      <description>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.</description>
      <arm_group_label>BLOOM Independent Outings</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Pediatric Inclusion Criteria:&#xD;
  &#xD;
            1. Age 9-12 years at enrollment&#xD;
  &#xD;
            2. Has an ACE Score of 1 or higher&#xD;
  &#xD;
            3. Has a SCARED-P score of 15 or higher&#xD;
  &#xD;
            4. Is available to attend three group outings if assigned to group intervention arm.&#xD;
  &#xD;
            5. Has a caregiver who is able to consent and attend outings with them.&#xD;
  &#xD;
            6. Is able to read, write, and speak English, Spanish or Arabic.&#xD;
  &#xD;
            7. Has no serious health conditions that affect their ability to be in nature.&#xD;
  &#xD;
            8. Willing to wear a provided electronic sensor continuously for 6 weeks, including&#xD;
               sleep, excluding bathing and device recharging time.&#xD;
  &#xD;
            9. Have no major changes in their mental health treatment plan during the time of the&#xD;
               study.&#xD;
  &#xD;
          Caregiver eligibility criteria&#xD;
  &#xD;
            1. Able to read, write and speak English, Spanish or Arabic&#xD;
  &#xD;
            2. Be at least 18 years old.&#xD;
  &#xD;
            3. Have no serious health conditions that affect their ability to be in nature.&#xD;
  &#xD;
            4. Is available to attend 6 weekly outings if assigned to group intervention arm.&#xD;
  &#xD;
            5. Have a smart phone and be willing to download NatureDose app from NatureQuant.&#xD;
  &#xD;
          Exclusion Criteria Child:&#xD;
  &#xD;
            1. Concomitant active treatment modification (eg medication changes) for the past month.&#xD;
  &#xD;
            2. Unable to attend weekly nature outings if randomized to the group intervention.&#xD;
  &#xD;
            3. Physical or health limitation to participating in outdoor activities.&#xD;
  &#xD;
            4. Previous SHINE participant.&#xD;
  &#xD;
            5. Caregiver unable to consent.&#xD;
  &#xD;
            6. Unable to pass short quiz at the end of the assent.&#xD;
  &#xD;
            7. Wards of the state who do not have a guardian other than the state who can consent on&#xD;
               their behalf.&#xD;
  &#xD;
            8. Non-English, Arabic or Spanish speaking participants.&#xD;
  &#xD;
            9. Unwilling to use a FitBit.&#xD;
  &#xD;
          Exclusion criteria - caregiver&#xD;
  &#xD;
            1. Unable to attend weekly nature outings if randomized to the group intervention.&#xD;
  &#xD;
            2. Physical or health limitation to participating in outdoor activities.&#xD;
  &#xD;
            3. Previous SHINE participant.&#xD;
  &#xD;
            4. Unable to provide informed consent.&#xD;
  &#xD;
            5. Non-English, Arabic or Spanish speaking participants.&#xD;
  &#xD;
            6. Unwilling to use NatureDose app.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>9 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nooshin Razani, MD MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>UCSF and UCSF Benioff Children's Hospital Oakland</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nooshin Razani, MD MPH</last_name>
      <phone>4155147877</phone>
      <email>nooshin.razani@ucsf.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amaka Agodi, BS</last_name>
      <phone>4155147877</phone>
      <email>amaka.agodi@ucsf.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UCSF Benioff Children's Hospitals</name>
        <address>
          <city>Oakland</city>
          <state>California</state>
          <zip>94609</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nooshin Razani, MD MPH</last_name>
        <phone>415-514-7877</phone>
        <email>nooshin.razani@ucsf.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Anxiety</keyword>
    <keyword>Pediatric Mental Health</keyword>
    <keyword>Adverse Childhood Experiences</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05973123
  org study id: 23-38315
  nct id: NCT05973123
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores
  time frame: 6 weeks
  description: 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.
  measure: Change in Brief Resiliency Screen amongst children
  time frame: 6 weeks
  description: 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.
  measure: Change in hair cortisol levels in enrolled children
  time frame: 6 weeks
  description: Hair Cortisol levels will be measured at baseline and at 6 weeks for participants who opt into the section of the study. Hair cortisol is a marker of stress over the previous month. Hair cortisol and cortisone levels will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Samples of hair (5mg, 40-50 stands, 2 cm long) will be obtained from the back of the scalp for consenting child participants.
  measure: Change in BMI amongst enrolled children
  time frame: 6 weeks
  description: Weight and height measurements will be obtained at baseline and at 6 weeks.
  measure: Change in child's nature exposure as measured by GPS coordinates
  time frame: 6 weeks
  description: Enrolled children will be asked to wear a FitBit during the course of the study. The FitBit will record the patients GPS coordinates during the course of the 6 weeks of the study. The GPS coordinates will be submitted to the NatureQuant organization without any identifying data. Using satellite and GIS data, NatureQuant will give the research team information about how much vegetation the child was around, and how many parks they visited during the 6 weeks of the study.
  measure: Change in caregiver stress as measured by the Perceived Stress Score (PSS-10)
  time frame: 6 weeks
  description: Caregivers will fill out the PSS10, a 10-item validated Likert scale, with responses to each item with five options (i.e., never, almost never, sometimes, usually, always). They will fill this out at baseline and at six weeks. A higher score corresponds with higher stress.
  measure: Changes in caregiver nature exposure as measured by NatureDose app
  time frame: 6 weeks
  description: Enrolled caregivers will be instructed on how to download the NatureDose app on their phones. They will register on the app using a unique research identifier code which does not have personal identifying data on it. The NatureDose app will follow the participant's gps coordinates during the course of the study in order to provide the research team with information about exposure to vegetation and park visits during the six week course fo this clinical trial.
  arm group label: BLOOM Group Outings
  arm group type: Experimental
  description: 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.
  arm group label: BLOOM Independent Outings
  arm group type: Experimental
  description: This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.
  arm group label: Control
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Group Nature Outings
  description: 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.
  arm group label: BLOOM Group Outings
  intervention type: Behavioral
  intervention name: Family Outings
  description: 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.
  arm group label: BLOOM Independent Outings
  criteria: 
  gender: All
  minimum age: 9 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nooshin Razani, MD MPH
  role: Principal Investigator
  affiliation: UCSF and UCSF Benioff Children's Hospital Oakland
  last name: Nooshin Razani, MD MPH
  phone: 4155147877
  email: nooshin.razani@ucsf.edu
  last name: Amaka Agodi, BS
  phone: 4155147877
  email: amaka.agodi@ucsf.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stress Disorders, Post-Traumatic
  sharing ipd: No