Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT03868761
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2019-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will be a randomized, open label non-concurrent multiple-baseline experimental study with participants acting as their own controls.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2019-03-05', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility: intervention retention: number of treatment completers', 'timeFrame': '4 months', 'description': 'retention (i.e., number of treatment completers)'}, {'measure': 'Feasibility: intervention safety: number of adverse events', 'timeFrame': '4 months', 'description': 'safety (i.e., number of adverse events)'}, {'measure': 'Feasibility: intervention adherence: number of treatment components completed', 'timeFrame': '4 months', 'description': 'adherence rates (i.e., number of treatment components completed)'}, {'measure': 'Feasibility: intervention satisfaction/acceptability', 'timeFrame': '4 months', 'description': '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)'}, {'measure': 'Feasibility: intervention promotion', 'timeFrame': '4 months', 'description': '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)'}, {'measure': 'Feasibility: engagement rate', 'timeFrame': '4 months', 'description': 'Engagement rate (i.e., Number and average length of logins to the mobile app intervention)'}, {'measure': 'PTSD Symptom Severity', 'timeFrame': '4 months', 'description': 'Child PTSD Symptom Scale for Diagnostic and Statistical Manual-5; score ranges from 0-80; higher scores indicate more PTSD symptom severity'}, {'measure': 'PTSD functional impairment', 'timeFrame': '4 months', 'description': 'Child PTSD Symptom Scale for Diagnostic and Statistical Manual-5; score ranges from 0-7; higher scores indicate more PTSD related functional impairment'}], 'secondaryOutcomes': [{'measure': 'Internalizing symptoms', 'timeFrame': '4 months', 'description': 'Behavior and Feelings Survey - Youth; range 0-24; higher scores indicate more internalizing symptoms (anxiety, depression, stress)'}, {'measure': 'Externalizing symptoms', 'timeFrame': '4 months', 'description': 'Behavior and Feelings Survey- Youth; range 0-24; higher scores indicate more externalizing symptoms (behavior problems)'}, {'measure': 'Psychosocial functioning', 'timeFrame': '4 months', 'description': 'Ohio Youth Scale - Functioning Subscale; Score range 0-80; higher score indicated better functioning'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile app', 'Disaster', 'Digital Medicine', 'Teens'], 'conditions': ['Disaster', 'PTSD', 'Adolescent Behavior', 'Trauma', 'Anxiety', 'Stress']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males \\& females aged 13-17 years directly impacted by the 2017 wildfires having lost their home or been temporarily displaced\n2. Screen positive for PTSD (Child Trauma Screening Questionnaire = 5 or higher)\n3. Have regular access to a smart phone and a computer\n4. Have a personal email address\n5. Speak and read English fluently\n6. Have parental consent\n\nExclusion Criteria:\n\n1. A positive self-reported history of psychosis, bipolar, or schizophrenia\n2. Serious self-reported physical health concerns necessitating surgery or with prognosis \\<6 months\n3. A positive screen for a current Substance User Disorder (CRAFFT = 2 or higher)\n4. Current self-reported suicidal ideation\n5. Self-reported pregnancy\n6. Self-reported less than four weeks of stable prescription medication for anxiety, anti-depressant, and sleep promoting medications prior to the screening assessment'}, 'identificationModule': {'nctId': 'NCT03868761', 'briefTitle': 'Feasibility and Efficacy of a Digital Mental Health Intervention for Teen Wildfire Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'IRB-49196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'description': '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.', 'interventionNames': ['Behavioral: Sonoma Rises']}], 'interventions': [{'name': 'Sonoma Rises', 'type': 'BEHAVIORAL', 'otherNames': ['Mobile Mental Health App'], 'description': '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.', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Adrienne Heinz, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Health Scientist', 'investigatorFullName': 'Adrienne Julie Heinz', 'investigatorAffiliation': 'Stanford University'}}}}