{ "FullStudy":{ "Rank":217765, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517126", "OrgStudyIdInfo":{ "OrgStudyId":"999912034" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"12-M-N034" } ] }, "Organization":{ "OrgFullName":"National Institutes of Health Clinical Center (CC)", "OrgClass":"NIH" }, "BriefTitle":"Assessing Suicide Risk in Adolescents With Developmental Delays", "OfficialTitle":"Assessing Suicide Risk in Adolescents With Developmental Delays: Development of a Screening Tool" }, "StatusModule":{ "StatusVerifiedDate":"September 2019", "OverallStatus":"Terminated", "WhyStopped":"slow accrual", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 6, 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 13, 2019", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 13, 2019", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 17, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 18, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"National Institute of Mental Health (NIMH)", "LeadSponsorClass":"NIH" } }, "OversightModule":{ "IsFDARegulatedDrug":"No", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"Background:\n\n- Currently, there is no standard method to study suicide risk in youth with developmental delays or intellectual disabilities (DD/ID). Youth with DD/ID are often excluded from studies that are used to develop these methods. As a result, most current suicide risk assessments have not been tested for use with people with DD/ID. Researchers want to develop an effective suicide risk screening tool for children and adolescents with DD/ID.\n\nObjectives:\n\n- To develop a suicide risk screening tool for young adults with DD/ID.\n\nEligibility:\n\nYoung adults between 12 and 21 years of age who have DD/ID and are in mental health counseling.\nParticipants will be in counseling at Surrey Place Centre, a community health center in Toronto, Canada.\n\nDesign:\n\nParticipants will fill out questionnaires during a 1-hour meeting with a therapist. The questions will ask about mood and current feelings, including whether the participant has been thinking about or planning to hurt or kill him or herself now or in the past. Other questions will ask about participants' understanding of death in general.\nParents of participants may also fill out a questionnaire. It will ask about how the participant has been feeling. It will also ask whether the parent has noticed any signs that suggest suicidal thoughts or actions, now and in the past.\nTreatment will not be provided as part of this protocol. However, participants can receive counseling through the regular Surrey Place Centre services.", "DetailedDescription":"Objective:\n\nCurrently, no gold standard is available for evaluating suicidal thoughts and behaviors in individuals with developmental delay or intellectual disabilities (DD/ID). Moreover, youth with DD are often excluded from instrument validation studies. Therefore, there is a paucity of sufficiently adapted and validated clinical suicide risk assessments for use with clients with DD/ID. The main objective of this study is to develop and assess the efficacy of a suicide screening tool for child and adolescent clients with DD/ID. More specifically:\n\nAim 1: To modify the Risk of Suicide Questionnaire (RSQ) in order to create a suicide screening tool for a pediatric mental health population with DD/ID.\n\nAim 2: To determine the feasibility of a suicide screening tool, (developed in Aim 1) to detect suicide risk in pediatric clients with DD/ID presenting to a community health center for mental health reasons.\n\nStudy population:\n\nThe NIMH is collaborating with Surrey Place Centre, a community health center in Toronto, Canada. The study population will be Surrey Place Centre clients, ages 12 and older, diagnosed with DD/ID, currently accessing individual mental health counseling. There will be no exclusion based on gender or race.\n\nDesign:\n\nThis will be a prospective instrument development study. Potential participants will be identified by research assistants (RAs) and therapists. Following informed consent and assent procedures, therapists will administer the Risk of Suicide Questionnaire Intellectual Disability Patient (RSQ-ID-Patient), and the Suicidal Ideation Questionnaire Child Version (SIQ-CV) to clients, and the RA will have the parents/guardians complete the Risk of Suicide Questionnaire-Intellectual Disability-Parent (RSQ-ID Parent). Three months after client participation, therapists will fill out a Therapist Follow-up Questionnaire.\n\nOutcome measures:\n\nPrimary outcome measures include the RSQ-ID Patient, and the SIQ-CV, along with the RSQ-ID Parent. Secondary outcome measure is the Research Assistant Evaluation Form and the Clinician Follow- up Form." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Child Development Disorders, Pervasive" ] }, "KeywordList":{ "Keyword":[ "Youth Suicide", "Suicide Screening", "Developmental Delay", "Intellectual Disability", "Assessment Instrument", "Mental Retardation", "Suicidal Thoughts", "Suicidal Behavior" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"17", "EnrollmentType":"Actual" } }, "EligibilityModule":{ "EligibilityCriteria":"INCLUSION CRITERIA:\n\nClient must be enrolled in individual counseling at the Surrey Center at time of participation and must have attended at least 3 therapy appointments.\n\nClients must have an IQ score betwen 55 and 75 (a range considered to \"mild developmental delay\"). A client with mild DD will have the ability to communicate verbally and provide writtent assent. In order to receive services at Surrey Place Centre, clients must have a designation of \"developmental delay\" with and IQ score or range. If they do not have an IQ Score or DD designation, they undergo assessment at intake. Therefore, each client will have an IQ score recorded prior to study recruitment.\n\nAge 12 years or older\n\nEnglish speaking\n\nA legal guardian must provide informed consent and client must sign an assent document. Verbal assent is not acceptable for participation.\n\nEXCLUSION CRITERIA:\n\nLegal guradian is non-English speaking and no translation support is available to assist with the consent process.\n\nNo IQ score on record.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"12 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Lisa M Horowitz, Ph.D.", "OverallOfficialAffiliation":"National Institute of Mental Health (NIMH)", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Surrey Place Centre", "LocationCity":"Toronto", "LocationCountry":"Canada" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013405", "ConditionMeshTerm":"Suicide" },{ "ConditionMeshId":"D000002658", "ConditionMeshTerm":"Developmental Disabilities" },{ "ConditionMeshId":"D000002659", "ConditionMeshTerm":"Child Development Disorders, Pervasive" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000016728", "ConditionAncestorTerm":"Self-Injurious Behavior" },{ "ConditionAncestorId":"D000001526", "ConditionAncestorTerm":"Behavioral Symptoms" },{ "ConditionAncestorId":"D000065886", "ConditionAncestorTerm":"Neurodevelopmental Disorders" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14774", "ConditionBrowseLeafName":"Suicide", "ConditionBrowseLeafAsFound":"Suicide", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4486", "ConditionBrowseLeafName":"Child Development Disorders, Pervasive", "ConditionBrowseLeafAsFound":"Child Development Disorders, Pervasive", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10172", "ConditionBrowseLeafName":"Intellectual Disability", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M27951", "ConditionBrowseLeafName":"Suicidal Ideation", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4485", "ConditionBrowseLeafName":"Developmental Disabilities", "ConditionBrowseLeafAsFound":"Child Development Disorders", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M17672", "ConditionBrowseLeafName":"Self-Injurious Behavior", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3399", "ConditionBrowseLeafName":"Behavioral Symptoms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M29231", "ConditionBrowseLeafName":"Neurodevelopmental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }