Nctid:
NCT06229223
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000059020", "term"=>"Suicidal Ideation"}], "ancestors"=>[{"id"=>"D000013405", "term"=>"Suicide"}, {"id"=>"D000016728", "term"=>"Self-Injurious Behavior"}, {"id"=>"D000001526", "term"=>"Behavioral Symptoms"}], "browseLeaves"=>[{"id"=>"M29364", "name"=>"Suicidal Ideation", "asFound"=>"Suicidal Ideation", "relevance"=>"HIGH"}, {"id"=>"M16191", "name"=>"Suicide", "relevance"=>"LOW"}, {"id"=>"M19089", "name"=>"Self-Injurious Behavior", "relevance"=>"LOW"}, {"id"=>"M4818", "name"=>"Behavioral Symptoms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>250}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-26", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2025-03", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-01", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Percent of Participants Screened", "timeFrame"=>"Monthly for 9 months", "description"=>"Percent of patients 12-18 years old screened for depression and suicidal ideation and behavior at clinic level"}, {"measure"=>"Feasibility as assessed by percent of sessions completed", "timeFrame"=>"Monthly for 9 months", "description"=>"Percent of eligible patients receiving a CHW session"}, {"measure"=>"Quality as assessed by percent of CHW visits", "timeFrame"=>"Monthly for 9 months", "description"=>"Percent of CHW visits that include delivery of one or more intervention components"}, {"measure"=>"Engagement as assessed by number of follow-up visits", "timeFrame"=>"Monthly for 9 months", "description"=>"number of follow-up mental health visits with PCP or specialty provider among youth identified as having suicidal ideation or behavior."}], "secondaryOutcomes"=>[{"measure"=>"Family Functioning as assessed by the SCORE-15 Index of Family Functioning and Change (SCORE-15)", "timeFrame"=>"Baseline and 3 months", "description"=>"SCORE-15 Index of Family Functioning and Change: Score range 5-15, higher total means worse functioning."}, {"measure"=>"Parent Self Efficacy as assessed by Brief Parenting Self Efficacy Scale (BPSES) Questionnaire", "timeFrame"=>"Baseline and 3 months", "description"=>"Brief Parenting Self Efficacy Scale (BPSES) Questionnaire: Total score ranges from 5 to 25, higher scores indicate higher levels of parental self-efficacy."}, {"measure"=>"Depression as assessed by the Patient Health Questionnaire - Adolescent (PHQ-A)", "timeFrame"=>"Baseline and 3 months", "description"=>"Patient Health Questionnaire - Adolescent (PHQ-A): Each item on the PHQ-A is scored as follows: Not at all = 0 Several Days = 1 More than half the days = 2 Nearly every day = 3. A weighted score of 5 or more means a positive screen for depressive symptoms. A weighted score of 0-4 means a negative screen for depressive symptoms."}, {"measure"=>"Suicidal Ideation and Behavior as assessed by the Ask Suicide-Screening Questionnaire (ASQ)", "timeFrame"=>"Baseline and 3 months", "description"=>"Ask Suicide-Screening Questionnaire (ASQ): 4 Yes or No Questions. \"Yes\" to questions 1 through 4, or refuses to answer is considered a positive screen. \"Yes\" to question 5 = acute positive screen (imminent risk identified); \"No\" to question 5 = non-acute positive screen."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Suicidal Ideation"]}, "descriptionModule"=>{"briefSummary"=>"The objective of this proposal is to develop and pilot a systems-level strategy in pediatric primary care to enhance identification and management of suicidal ideation and behavior in Latinx youth, particularly those in immigrant families with parents who have limited English proficiency (LEP). The investigators will focus on the use of trained community health workers (CHWs) to increase clinic capacity and quality of suicide risk screening and early intervention, with a focus on safety planning, parent psychoeducation and care coordination.\n\nSpecific aims are 1: To develop site-specific implementation protocols for the integration of CHWs into SIB screening and safety planning for Latinx youth and the youths families; 2: To pilot the implementation of the program in a six-month open trial in four pediatric primary care practices representing a range of usual practice settings; and 3: To engage a stakeholder network to explore barriers and facilitators, including costs and billing strategies, to implementation of this approach across a broad range of pediatric primary care settings.\n\nParents/guardians of youth who have been referred to and agree to participate in the intervention by the child's primary care provider will participate in a 2-month program consisting of 6-8 phone sessions with a community health worker focusing on safety planning, information/education, program solving and self-care. Research participants will be asked to complete a survey via phone at the beginning of the program and another at the end of the program. The participants may also be asked to participate in an additional interview about the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"25 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Youth and their parents who work with the community health worker and\n* who speak English or Spanish and\n* identify as Latino/Latinx/Hispanic/Latin American are eligible for enrollment in the study\n\nExclusion Criteria:\n\n* None"}, "identificationModule"=>{"nctId"=>"NCT06229223", "briefTitle"=>"Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care", "organization"=>{"class"=>"OTHER", "fullName"=>"Johns Hopkins University"}, "officialTitle"=>"Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care", "orgStudyIdInfo"=>{"id"=>"IRB00378575"}, "secondaryIdInfos"=>[{"id"=>"R34MH129771", "link"=>"https://reporter.nih.gov/quickSearch/R34MH129771", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"PALOMA", "description"=>"Parents/guardians of youth who have been referred to and agree to participate in the intervention by the child's primary care provider will participate in a 2-month program consisting of 5-7 phone sessions with a community health worker focusing on safety planning, information/education, program solving and self-care. Research participants will be asked to complete a survey via phone at the beginning of the program and another at the end of the program. The participants may also be asked to participate in an additional interview about the participants experience during the study.", "interventionNames"=>["Behavioral: PALOMA"]}], "interventions"=>[{"name"=>"PALOMA", "type"=>"BEHAVIORAL", "description"=>"Partnering with Parents of Adolescent Latinos on Mental Health Assistance", "armGroupLabels"=>["PALOMA"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21224", "city"=>"Baltimore", "state"=>"Maryland", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Sarah Polk, MD", "role"=>"CONTACT"}], "facility"=>"BMS at Yard 56", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}], "centralContacts"=>[{"name"=>"Ellen Molino", "role"=>"CONTACT", "email"=>"emolino1@jh.edu", "phone"=>"14105509019"}, {"name"=>"Sarah Polk, MD", "role"=>"CONTACT", "email"=>"spolk@jhmi.edu", "phone"=>"4105504114"}], "overallOfficials"=>[{"name"=>"Sarah Polk, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Johns Hopkins School of Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"YES", "description"=>"Data will be made available while safeguarding the privacy of participants, \\& protecting confidential \\& proprietary data. Investigators will have access to results free from personal identifiers \\& PHI. Investigators will fill out a request form that specifies the purpose of the request, the data requested \\& the qualifications of the requestor. Final research data will include recorded factual material necessary to document \\& support research findings, including final data sets (w/ identifiers redacted), data collection protocols data, \\& database documentation. Users must agree to the conditions of use governing access to the publicly released data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, restrictions on use for commercial purposes, \\& proper acknowledgement of the data resource."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Johns Hopkins University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
