Back to resultsFeasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors
Primary Purpose
Disaster, PTSD, Adolescent Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sonoma Rises
Sponsored by
About this trial
This is an interventional treatment trial for Disaster focused on measuring Mobile app, Disaster, Digital Medicine, Teens
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility: intervention retention: number of treatment completers
retention (i.e., number of treatment completers)
Feasibility: intervention safety: number of adverse events
safety (i.e., number of adverse events)
Feasibility: intervention adherence: number of treatment components completed
adherence rates (i.e., number of treatment components completed)
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)
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)
Feasibility: engagement rate
Engagement rate (i.e., Number and average length of logins to the mobile app intervention)
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
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
Secondary Outcome Measures
Internalizing symptoms
Behavior and Feelings Survey - Youth; range 0-24; higher scores indicate more internalizing symptoms (anxiety, depression, stress)
Externalizing symptoms
Behavior and Feelings Survey- Youth; range 0-24; higher scores indicate more externalizing symptoms (behavior problems)
Psychosocial functioning
Ohio Youth Scale - Functioning Subscale; Score range 0-80; higher score indicated better functioning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03868761
Brief Title
Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
November 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disaster, PTSD, Adolescent Behavior, Trauma, Anxiety, Stress
Keywords
Mobile app, Disaster, Digital Medicine, Teens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sonoma Rises
Other Intervention Name(s)
Mobile Mental Health App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility: intervention retention: number of treatment completers
Description
retention (i.e., number of treatment completers)
Time Frame
4 months
Title
Feasibility: intervention safety: number of adverse events
Description
safety (i.e., number of adverse events)
Time Frame
4 months
Title
Feasibility: intervention adherence: number of treatment components completed
Description
adherence rates (i.e., number of treatment components completed)
Time Frame
4 months
Title
Feasibility: intervention satisfaction/acceptability
Description
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
Title
Feasibility: intervention promotion
Description
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
Title
Feasibility: engagement rate
Description
Engagement rate (i.e., Number and average length of logins to the mobile app intervention)
Time Frame
4 months
Title
PTSD Symptom Severity
Description
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
Title
PTSD functional impairment
Description
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 Outcome Measure Information:
Title
Internalizing symptoms
Description
Behavior and Feelings Survey - Youth; range 0-24; higher scores indicate more internalizing symptoms (anxiety, depression, stress)
Time Frame
4 months
Title
Externalizing symptoms
Description
Behavior and Feelings Survey- Youth; range 0-24; higher scores indicate more externalizing symptoms (behavior problems)
Time Frame
4 months
Title
Psychosocial functioning
Description
Ohio Youth Scale - Functioning Subscale; Score range 0-80; higher score indicated better functioning
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne Heinz, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors
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