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

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ClinicalTrials.gov Identifier: NCT03868761
Recruitment Status : Not yet recruiting
First Posted : March 11, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Adrienne Julie Heinz, Stanford University

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
Disaster PTSD Adolescent Behavior Trauma Anxiety Stress Behavioral: Sonoma Rises Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
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.
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.
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Mobile Mental Health App




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868761


Contacts
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Contact: Adrienne J Heinz, Ph.D. 919-630-6847 aheinz@stanford.edu
Contact: Shannon Wiltsey-Stirman, Ph.D. 650-493-5000 sws1@stanford.edu

Locations
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United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Mehret Assefa, Ph.D.         
Principal Investigator: Adrienne J Heinz, Ph.D.         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Adrienne Heinz, Ph.D. Stanford University

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Responsible Party: Adrienne Julie Heinz, Research Health Scientist, Stanford University
ClinicalTrials.gov Identifier: NCT03868761     History of Changes
Other Study ID Numbers: IRB-49196
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adrienne Julie Heinz, Stanford University:
Mobile app
Disaster
Digital Medicine
Teens