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

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.

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Stress; Anxiety; Trauma; Adolescent Behavior; Disaster
• Intervention / Treatment: Behavioral: Sonoma Rises

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single Arm; 21 male and female teenage participants will be randomized to one of three varying baseline assessment periods of two, four, or six weeks. Multiple baseline is a type of single-case experimental design (SCED) that is a time- and cost-effective method for evaluating efficacy of a new treatment, Sonoma Rises. The randomization of participants to baseline periods of varying lengths enables assessment of whether symptom changes occur when, and only when, the intervention is applied.

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.; Other Names: Mobile Mental Health App

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: intervention retention: number of treatment completers	retention (i.e., number of treatment completers)	4 months
Feasibility: intervention safety: number of adverse events	safety (i.e., number of adverse events)	4 months
Feasibility: intervention adherence: number of treatment components completed	adherence rates (i.e., number of treatment components completed)	4 months
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
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
Feasibility: engagement rate	Engagement rate (i.e., Number and average length of logins to the mobile app intervention)	4 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internalizing symptoms	Behavior and Feelings Survey - Youth; range 0-24; higher scores indicate more internalizing symptoms (anxiety, depression, stress)	4 months
Externalizing symptoms	Behavior and Feelings Survey- Youth; range 0-24; higher scores indicate more externalizing symptoms (behavior problems)	4 months
Psychosocial functioning	Ohio Youth Scale - Functioning Subscale; Score range 0-80; higher score indicated better functioning	4 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Adrienne Heinz, Ph.D., Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): November 22, 2020

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Teens; Digital Medicine; Mobile app; Disaster
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IRB-49196

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No