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CompletedNCT03868761Updated Nov 24, 2020

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

An interventional study of Sonoma Rises in Disaster, PTSD and Adolescent Behavior, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
13 Years to 17 Years
Sex
All
01

Study 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.

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Conditions studied

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

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Keywords

  • Mobile app
  • Disaster
  • Digital Medicine
  • Teens
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In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 7 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralSonoma 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.

    Also known as: Mobile Mental Health App

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What researchers measure

Primary outcomes

  1. Feasibility: intervention retention: number of treatment completers

    retention (i.e., number of treatment completers)

    Time frame: 4 months

  2. Feasibility: intervention safety: number of adverse events

    safety (i.e., number of adverse events)

    Time frame: 4 months

  3. Feasibility: intervention adherence: number of treatment components completed

    adherence rates (i.e., number of treatment components completed)

    Time frame: 4 months

  4. 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)

    Time frame: 4 months

  5. 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)

    Time frame: 4 months

  6. Feasibility: engagement rate

    Engagement rate (i.e., Number and average length of logins to the mobile app intervention)

    Time frame: 4 months

  7. 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

    Time frame: 4 months

  8. 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

    Time frame: 4 months

Secondary outcomes

  1. Internalizing symptoms

    Behavior and Feelings Survey - Youth; range 0-24; higher scores indicate more internalizing symptoms (anxiety, depression, stress)

    Time frame: 4 months

  2. Externalizing symptoms

    Behavior and Feelings Survey- Youth; range 0-24; higher scores indicate more externalizing symptoms (behavior problems)

    Time frame: 4 months

  3. Psychosocial functioning

    Ohio Youth Scale - Functioning Subscale; Score range 0-80; higher score indicated better functioning

    Time frame: 4 months

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Study locations

1 site
  • Stanford University
    Palo Alto, California 94304, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03868761
Lead sponsor
Stanford University
Responsible party
Adrienne Julie Heinz (Research Health Scientist, Stanford University) — Principal investigator
First posted
Mar 11, 2019
Start date
Apr 1, 2019
Primary completion
Jan 31, 2020
Completion
Nov 22, 2020
Last update
Nov 24, 2020

Study contacts

Adrienne Heinz, Ph.D.
principal investigator · Stanford University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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