Assessing Suicide Risk in Adolescents With Developmental Delays
|First Received Date ICMJE||January 24, 2012|
|Last Updated Date||August 23, 2016|
|Start Date ICMJE||January 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01517126 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Assessing Suicide Risk in Adolescents With Developmental Delays|
|Official Title ICMJE||Assessing Suicide Risk in Adolescents With Developmental Delays: Development of a Screening Tool|
- 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.
- To develop a suicide risk screening tool for young adults with DD/ID.
Currently, 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:
Aim 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.
Aim 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.
The 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.
This 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.
Primary 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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Child Development Disorders, Pervasive|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||250|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Client must be enrolled in individual counseling at the Surrey Center at time of participation and must have attended at least 3 therapy appointments.
Clients 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.
Age 12 years or older
A legal guardian must provide informed consent and client must sign an assent document. Verbal assent is not acceptable for participation.
Legal guradian is non-English speaking and no translation support is available to assist with the consent process.
No IQ score on record.
|Ages||12 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT01517126|
|Other Study ID Numbers ICMJE||999912034, 12-M-N034|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Mental Health (NIMH)|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP