Child Development Disorders, PervasiveNCT01517126
Assessing Suicide Risk in Adolescents With Developmental Delays
An observational study of Child Development Disorders, Pervasive, run by National Institute of Mental Health (NIMH) at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Child Development Disorders, Pervasive
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2012to 13 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Legal guradian is non-English speaking and no translation support is available to assist with the consent process.
- No IQ score on record.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Suicide Risk in Adolescents With Developmental Delays: Development of a Screening Tool
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.
Read more
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.
Read the 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.
- Conditions
- Child Development Disorders, Pervasive
- Keywords
- Youth Suicide, Suicide Screening, Developmental Delay, Intellectual Disability, Assessment Instrument, Mental Retardation, Suicidal Thoughts, Suicidal Behavior
- Medical subject headings
- Child Development Disorders, Pervasive, Learning Disabilities, Intellectual Disability, Suicidal Ideation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study start6 Jan 2012
- Primary completion13 Sep 2019
- Study completion13 Sep 2019
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development Disorders, PervasiveStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa M Horowitz, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517126
- Sponsor's protocol ID
- 999912034
- Other IDs
- 12-M-N034
- Status last verified
- Sep 2019
- First submitted
- 24 Jan 2012
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Suicide Risk in Adolescents With Developmental Delays: Development of a Screening Tool
- ClinicalTrials.gov ID
- NCT01517126
- Acronym / sponsor ID
- 999912034
- Conditions
- Child Development Disorders, Pervasive
- Keywords
- Youth Suicide, Suicide Screening, Developmental Delay, Intellectual Disability, Assessment Instrument, Mental Retardation, Suicidal Thoughts, Suicidal Behavior
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 6 Jan 2012
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Legal guradian is non-English speaking and no translation support is available to assist with the consent process.
- No IQ score on record.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Horowitz, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development Disorders, Pervasive, run by National Institute of Mental Health (NIMH) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.