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Completed

NCT Number: NCT03868761

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

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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Key information

Conditions

Disaster Adolescent Behavior Anxiety Anxiety Disorders Behavior Mental Disorders PTSD Stress Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma Trauma and Stressor Related Disorders Wounds and Injuries

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males & females aged 13-17 years directly impacted by the 2017 wildfires having lost their home or been temporarily displaced
  • Screen positive for PTSD (Child Trauma Screening Questionnaire = 5 or higher)
  • Have regular access to a smart phone and a computer
  • Have a personal email address
  • Speak and read English fluently
  • Have parental consent

Exclusion criteria

  • A positive self-reported history of psychosis, bipolar, or schizophrenia
  • Serious self-reported physical health concerns necessitating surgery or with prognosis <6 months
  • A positive screen for a current Substance User Disorder (CRAFFT = 2 or higher)
  • Current self-reported suicidal ideation
  • Self-reported pregnancy
  • Self-reported less than four weeks of stable prescription medication for anxiety, anti-depressant, and sleep promoting medications prior to the screening assessment

Treatment and study plan

Sonoma Rises

Behavioral

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

Primary outcomes

  1. Feasibility: intervention retention: number of treatment completers

    Time frame: 4 months

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

  2. Feasibility: intervention safety: number of adverse events

    Time frame: 4 months

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

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

    Time frame: 4 months

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

  4. Feasibility: intervention satisfaction/acceptability

    Time frame: 4 months

    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)

  5. Feasibility: intervention promotion

    Time frame: 4 months

    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)

  6. Feasibility: engagement rate

    Time frame: 4 months

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

  7. PTSD Symptom Severity

    Time frame: 4 months

    Child PTSD Symptom Scale for Diagnostic and Statistical Manual-5; score ranges from 0-80; higher scores indicate more PTSD symptom severity

  8. PTSD functional impairment

    Time frame: 4 months

    Child PTSD Symptom Scale for Diagnostic and Statistical Manual-5; score ranges from 0-7; higher scores indicate more PTSD related functional impairment

Secondary outcomes

  1. Internalizing symptoms

    Time frame: 4 months

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

  2. Externalizing symptoms

    Time frame: 4 months

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

  3. Psychosocial functioning

    Time frame: 4 months

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2019
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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