DisasterNCT03868761
Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors
A study testing Sonoma Rises in people with Disaster and PTSD, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Disaster, PTSD, Adolescent Behavior
- What is being tested?
- Sonoma Rises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 22 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Sonoma Rises
- Keywords
- Mobile app, Disaster, Digital Medicine, Teens
- Medical subject headings
- Stress Disorders, Post-Traumatic, Adolescent Behavior, Wounds and Injuries, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonoma RisesBehavioural
Also called Mobile Mental Health App
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | 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. Receives: Behavioral: Sonoma Rises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: intervention retention: number of treatment completers
retention (i.e., number of treatment completers)
Measured: 4 months
Feasibility: intervention safety: number of adverse events
safety (i.e., number of adverse events)
Measured: 4 months
Feasibility: intervention adherence: number of treatment components completed
adherence rates (i.e., number of treatment components completed)
Measured: 4 months
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)
Measured: 4 months
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)
Measured: 4 months
Feasibility: engagement rate
Engagement rate (i.e., Number and average length of logins to the mobile app intervention)
Measured: 4 months
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
Measured: 4 months
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
Measured: 4 months
Secondary outcomes (3)
Internalizing symptoms
Behavior and Feelings Survey - Youth; range 0-24; higher scores indicate more internalizing symptoms (anxiety, depression, stress)
Measured: 4 months
Externalizing symptoms
Behavior and Feelings Survey- Youth; range 0-24; higher scores indicate more externalizing symptoms (behavior problems)
Measured: 4 months
Psychosocial functioning
Ohio Youth Scale - Functioning Subscale; Score range 0-80; higher score indicated better functioning
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Jan 2020
- Study completion22 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisasterStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrienne Julie Heinz, Stanford University
- Investigators
- Adrienne Heinz, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868761
- Sponsor's protocol ID
- IRB-49196
- Status last verified
- Nov 2020
- First submitted
- 5 Mar 2019
- Last updated
- 24 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03868761
- Acronym / sponsor ID
- IRB-49196
- Keywords
- Mobile app, Disaster, Digital Medicine, Teens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 22 Nov 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be a randomized, open label non-concurrent multiple-baseline experimental study with participants acting as their own controls.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Behavioral: Sonoma Rises21 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonoma RisesAlso: Mobile Mental Health AppAll 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. | Behavioural | Single Arm |
Primary outcome
Feasibility: intervention retention: number of treatment completers
Time frame: 4 months
retention (i.e., number of treatment completers)
Feasibility: intervention safety: number of adverse events
Time frame: 4 months
safety (i.e., number of adverse events)
Feasibility: intervention adherence: number of treatment components completed
Time frame: 4 months
adherence rates (i.e., number of treatment components completed)
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)
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)
Feasibility: engagement rate
Time frame: 4 months
Engagement rate (i.e., Number and average length of logins to the mobile app intervention)
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
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
3 secondary outcomes
Internalizing symptoms
Time frame: 4 months
Externalizing symptoms
Time frame: 4 months
Psychosocial functioning
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Heinz, Ph.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonoma Rises in people with Disaster and PTSD, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: intervention retention: number of treatment completers (time frame: 4 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.