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

NCT03868761 | Completed

• 1 other identifier: IRB-49196
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Disaster; PTSD; Adolescent Behavior; Trauma; Anxiety; Stress

Keywords

Mobile app; Disaster; Digital Medicine; Teens

Outcome Measures

Primary Outcomes (8)

• Feasibility: intervention retention: number of treatment completers

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

  4 months

• Feasibility: intervention safety: number of adverse events

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

  4 months

• Feasibility: intervention adherence: number of treatment components completed

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

  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)

  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)

  4 months

• Feasibility: engagement rate

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

  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

  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

  4 months

Secondary Outcomes (3)

• Internalizing symptoms

  4 months

• Externalizing symptoms

  4 months

• Psychosocial functioning

  4 months

Study Arms (1)

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.

Behavioral: Sonoma Rises

Interventions

Sonoma Rises BEHAVIORAL

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.

Also known as: Mobile Mental Health App

Single Arm

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Adolescent Behavior; Wounds and Injuries; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Study Officials

• Adrienne Heinz, Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist

Model Details: The study will be a randomized, open label non-concurrent multiple-baseline experimental study with participants acting as their own controls.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 11, 2019
• Study Start: April 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: November 22, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

US (1)