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Behavioural Intervention

BLOOM Independent Outings for Post-Traumatic Stress Disorder (BLOOM Trial)

N/A
Recruiting
Led By Nooshin Razani, MD MPH
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

BLOOM Trial Summary

This trial aims to evaluate a nature-based program for children with a history of ACEs to see if it can help reduce anxiety. It will compare the benefits of group and independent outing models to a wait-listed control group.

Eligible Conditions
  • Post-Traumatic Stress Disorder
  • Adverse Childhood Experiences
  • Loneliness
  • Anxiety

BLOOM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Screen for Child Anxiety Related Emotional Disorders - Parent (SCARED-P) Scores
Secondary outcome measures
Change in Brief Resiliency Screen amongst children
Other outcome measures
Change in BMI amongst enrolled children
Change in caregiver stress as measured by the Perceived Stress Score (PSS-10)
Change in child's nature exposure as measured by GPS coordinates
+2 more

BLOOM Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: BLOOM Independent OutingsExperimental Treatment1 Intervention
This group receives text support in going outdoors as a family once a week for 6 weeks to gain skills in managing anxiety.
Group II: BLOOM Group OutingsExperimental Treatment1 Intervention
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.
Group III: ControlActive Control1 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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,517 Previous Clinical Trials
15,240,903 Total Patients Enrolled
Nooshin Razani, MD MPHPrincipal InvestigatorUCSF and UCSF Benioff Children's Hospital Oakland

Media Library

BLOOM (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05973123 — N/A
Post-Traumatic Stress Disorder Research Study Groups: BLOOM Independent Outings, Control, BLOOM Group Outings
Post-Traumatic Stress Disorder Clinical Trial 2023: BLOOM Highlights & Side Effects. Trial Name: NCT05973123 — N/A
BLOOM (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05973123 — N/A
~69 spots leftby May 2025
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