Assessing Suicide Risk in Adolescents With Developmental Delays

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01517126
First received: January 24, 2012
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

Background:

- 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.

Objectives:

- To develop a suicide risk screening tool for young adults with DD/ID.

Eligibility:

  • Young adults between 12 and 21 years of age who have DD/ID and are in mental health counseling.
  • Participants will be in counseling at Surrey Place Centre, a community health center in Toronto, Canada.

Design:

  • Participants 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.
  • Parents 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.
  • Treatment will not be provided as part of this protocol. However, participants can receive counseling through the regular Surrey Place Centre services.

Condition
Child Development Disorders, Pervasive

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessing Suicide Risk in Adolescents With Developmental Delays: Development of a Screening Tool

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 250
Study Start Date: January 2012
Detailed Description:

Objective:

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.

Study population:

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.

Design:

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.

Outcome measures:

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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

English speaking

A legal guardian must provide informed consent and client must sign an assent document. Verbal assent is not acceptable for participation.

EXCLUSION CRITERIA:

Legal guradian is non-English speaking and no translation support is available to assist with the consent process.

No IQ score on record.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517126

Contacts
Contact: Lisa M Horowitz, Ph.D. (301) 435-6052 horowitzl@mail.nih.gov

Locations
Canada
Surrey Place Centre Recruiting
Toronto, Canada
Sponsors and Collaborators
Investigators
Principal Investigator: Lisa M Horowitz, Ph.D. National Institute of Mental Health (NIMH)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01517126     History of Changes
Other Study ID Numbers: 999912034, 12-M-N034
Study First Received: January 24, 2012
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Youth Suicide
Suicide Screening
Developmental Delay
Intellectual Disability
Assessment Instrument
Mental Retardation
Suicidal Thoughts
Suicidal Behavior

Additional relevant MeSH terms:
Developmental Disabilities
Child Development Disorders, Pervasive
Suicide
Mental Disorders Diagnosed in Childhood
Mental Disorders
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 11, 2014