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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03868761
Collaborator
(none)
7
Enrollment
1
Location
1
Arm
19.7
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sonoma Rises
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study will be a randomized, open label non-concurrent multiple-baseline experimental study with participants acting as their own controls.The study will be a randomized, open label non-concurrent multiple-baseline experimental study with participants acting as their own controls.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Nov 22, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility: intervention retention: number of treatment completers [4 months]

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

    2. Feasibility: intervention safety: number of adverse events [4 months]

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

    3. Feasibility: intervention adherence: number of treatment components completed [4 months]

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

    4. Feasibility: intervention satisfaction/acceptability [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 [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 [4 months]

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

    7. PTSD Symptom Severity [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 [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 Outcome Measures

    1. Internalizing symptoms [4 months]

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

    2. Externalizing symptoms [4 months]

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

    3. Psychosocial functioning [4 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 17 Years
    Sexes Eligible for Study:
    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:

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Palo Alto California United States 94304

    Sponsors and Collaborators

    • Stanford University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Adrienne Julie Heinz, Research Health Scientist, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03868761
    Other Study ID Numbers:
    • IRB-49196
    First Posted:
    Mar 11, 2019
    Last Update Posted:
    Nov 24, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Adrienne Julie Heinz, Research Health Scientist, Stanford University
    Mobile app
    Disaster
    Digital Medicine
    Teens
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Nov 24, 2020