Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors

Anxiety Clinical Trial

Official title:

Feasibility and Preliminary Efficacy of a Digital Mental Health Intervention to Reduce Symptoms of Post-Disaster Traumatic Stress, Depression, and Anxiety in Teens Impacted by Wildfires: A Randomized Multiple-Baseline Single-Case Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868761
• Other study ID #: IRB-49196
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 22, 2020

Study information

• Verified date: November 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In October, 2017, Northern California experienced devastating and historic wildfires. Sonoma Rises is an app designed for anyone who was impacted by this event and is intended to help survivors of disaster find their new normal. This study will assess the feasibility and efficacy of a self-help post-disaster mental health intervention delivered via a mobile app with a sample of teens who are experiencing post-disaster mental health symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 22, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Males & females aged 13-17 years directly impacted by the 2017 wildfires having lost their home or been temporarily displaced

2. Screen positive for PTSD (Child Trauma Screening Questionnaire = 5 or higher)

3. Have regular access to a smart phone and a computer

4. Have a personal email address

5. Speak and read English fluently

6. Have parental consent

Exclusion Criteria:

1. A positive self-reported history of psychosis, bipolar, or schizophrenia

2. Serious self-reported physical health concerns necessitating surgery or with prognosis <6 months

3. A positive screen for a current Substance User Disorder (CRAFFT = 2 or higher)

4. Current self-reported suicidal ideation

5. Self-reported pregnancy

6. Self-reported less than four weeks of stable prescription medication for anxiety, anti-depressant, and sleep promoting medications prior to the screening assessment

Related Conditions & MeSH terms

• Adolescent Behavior
• Anxiety
• Anxiety Disorders
• Disaster
• PTSD
• Stress
• Trauma

Intervention

Behavioral:
• Sonoma Rises
All participants will receive the intervention, Sonoma Rises, a mobile app designed by psychologists at the National Center for PTSD for wildfire survivors to facilitate recovery from disaster. Users can access evidence-informed tools to help cope with stress, heal from loss, prioritize self-care, connect with others, manage anger, and track their mood using validated assessments. There are also tools designed just for teens and users are linked to psychoeducation on disaster and health and other mental health resources and services.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: intervention retention: number of treatment completers	retention (i.e., number of treatment completers)	4 months
Primary	Feasibility: intervention safety: number of adverse events	safety (i.e., number of adverse events)	4 months
Primary	Feasibility: intervention adherence: number of treatment components completed	adherence rates (i.e., number of treatment components completed)	4 months
Primary	Feasibility: intervention satisfaction/acceptability	satisfaction/acceptability (i.e., participant satisfaction with treatment "how would you rate your overall satisfaction with the program?"- range 0-10 - higher score indicates more satisfaction)	4 months
Primary	Feasibility: intervention promotion	Net promoter score (i.e., "How likely are you to recommend this to a friend?" score range 0-5; lower score indicates higher likelihood of promotion)	4 months
Primary	Feasibility: engagement rate	Engagement rate (i.e., Number and average length of logins to the mobile app intervention)	4 months
Primary	PTSD Symptom Severity	Child PTSD Symptom Scale for Diagnostic and Statistical Manual-5; score ranges from 0-80; higher scores indicate more PTSD symptom severity	4 months
Primary	PTSD functional impairment	Child PTSD Symptom Scale for Diagnostic and Statistical Manual-5; score ranges from 0-7; higher scores indicate more PTSD related functional impairment	4 months
Secondary	Internalizing symptoms	Behavior and Feelings Survey - Youth; range 0-24; higher scores indicate more internalizing symptoms (anxiety, depression, stress)	4 months
Secondary	Externalizing symptoms	Behavior and Feelings Survey- Youth; range 0-24; higher scores indicate more externalizing symptoms (behavior problems)	4 months
Secondary	Psychosocial functioning	Ohio Youth Scale - Functioning Subscale; Score range 0-80; higher score indicated better functioning	4 months