BLOOM: Boldly Living outdOOrs for Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric 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
- •Able to read, write and speak English, Spanish or Arabic
- •Be at least 18 years old.
- •Have no serious health conditions that affect their ability to be in nature.
- •Is available to attend 6 weekly outings if assigned to group intervention arm.
- •Have a smart phone and be willing to download NatureDose app from NatureQuant.
排除标准
- •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.
- •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.
- •Exclusion criteria - caregiver
- •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.
研究组 & 干预措施
BLOOM Independent Outings
This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.
干预措施: Family Outings (Behavioral)
Control
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.
BLOOM Group 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.
干预措施: Group Nature Outings (Behavioral)
结局指标
主要结局
Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores
时间窗: 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.
次要结局
- Change in Brief Resiliency Screen amongst children(6 weeks)