Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors (NCT03868761) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors
United States7 participantsStarted 2019-04-01
Plain-language 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.
Who can participate
Age range
13 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility: intervention retention: number of treatment completers
Timeframe: 4 months
2
Feasibility: intervention safety: number of adverse events
Timeframe: 4 months
3
Feasibility: intervention adherence: number of treatment components completed
. 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