Clinical trial NCT03868761: 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
Overall status: COMPLETED
Phase: NA
Conditions: Disaster
PTSD
Adolescent Behavior
Trauma
Anxiety
Stress
Keywords: Mobile app
Disaster
Digital Medicine
Teens
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 7
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be a randomized, open label non-concurrent multiple-baseline experimental study with participants acting as their own controls.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Feasibility: intervention retention: number of treatment completers
timeFrame: 4 months
measure: Feasibility: intervention safety: number of adverse events
timeFrame: 4 months
measure: Feasibility: intervention adherence: number of treatment components completed
timeFrame: 4 months
measure: Feasibility: intervention satisfaction/acceptability
timeFrame: 4 months
measure: Feasibility: intervention promotion
timeFrame: 4 months
measure: Feasibility: engagement rate
timeFrame: 4 months
measure: PTSD Symptom Severity
timeFrame: 4 months
measure: PTSD functional impairment
timeFrame: 4 months
Secondary outcomes:
measure: Internalizing symptoms
timeFrame: 4 months
measure: Externalizing symptoms
timeFrame: 4 months
measure: Psychosocial functioning
timeFrame: 4 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Adrienne Heinz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: