SuicideFSPSNCT03488602
Focused Suicide Prevention Strategy for Youth
A study testing F-SPS+UC and EUC in people with Suicide and Suicide, Attempted, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study evaluates whether a Family-centered suicide prevention strategy, when added to usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Suicide, Suicide, Attempted, Suicidal Ideation
- What is being tested?
- F-SPS+UC and EUC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to Jul 2020
- Phase
- Interventional
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 12 to18 years
- Youth presenting in the Emergency Department with acute suicidal ideation or suicide risk behaviour
- SIQ-Jr score ≥ 31
- Parent or caregiver able to communicate in English, or is willing to communicate using a hospital-organized translator, and willing to participate in study
- Living in the greater Toronto area and access to a telephone.
Who cannot join
- Active psychosis or hypomania/mania
- Moderate to severe intellectual disability, autism.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Matthew Tracey
Toronto, Ontario, M5G 1X8
Matthew Tracey, MA, 4165358501 ext. 201575, matthew.tracey@sickkids.ca
Reva Schachter, MSc, 4165358501 ext. 201469, reva.schachter@sickkids.ca
About this study
Official title: A Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Randomized Controlled Trial
This study evaluates whether a Family-centered suicide prevention strategy, when added to usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. Half of the participants will be randomized to receive F-SPS + UC and half will receive EUC.
Read the detailed description
This is a RCT of a patient- and family-centered suicide prevention intervention added to usual care (F-SPS + UC) for adolescents aged 12 to 18 years who present to the Emergency Department (ED) with suicidal ideation or suicide risk behaviours. The investigators will determine whether the F-SPS + UC intervention is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide.
F-SPS is a 6-week, standardized, manualized outpatient program that teaches participants to the skills to manage suicidal thoughts and impulses effectively. The family component addresses conflictual relationships that may be present in the family as well as improving family communication.
Enhanced usual care consists of 6 weekly telephone calls to ensure that the participant has connected with community resources suggested by the ED team and provide additional resources as needed.
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation
- Being tested
- F-SPS+UC, EUC
- Medical subject headings
- Suicide, Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-SPS+UCBehavioural
Also called F-SPS + UC
Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks.
Participants will continue to receive usual care.
EUCBehavioural
Weekly telephone contact with parents regarding participant health care utilization. Referrals to community mental health resources provided as needed.
Participants will continue to receive usual care.
| Study group | Role | What they receive |
|---|---|---|
| F-SPS Intervention | Experimental | This group will receive the F-SPS intervention. Receives: Behavioral: F-SPS+UC |
| Enhanced Usual Care (EUC) | Active comparator | This group will receive Enhanced Usual Care (EUC) Receives: Behavioral: EUC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr
a 15-item measure self-report of suicide ideation (e.g., thoughts about death and dying) completed by the patient. Items are scored from 0 to 6, yielding a score from 0 to 90. Higher scores indicate more severe suicidal ideation.
Measured: Screening, 6 weeks, 24 weeks
Secondary outcomes (7)
Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised
A 4-item self-report questionnaire that measures suicide behavior, and yields a total score of 3 - 18. Higher scores indicate more severe suicidal behavior.
Measured: Screening, 6 weeks, 24 weeks
Changes in emotional regulation using the Life Problems Inventory
A 60-item self-report scale that measures emotional regulation on a 5 point Likert scale from 1 to 5. Higher scores indicate more impaired emotional regulation. The measure has four subscales: Confusion about Self, Impulsivity, Emotion Dysregulation, and Interpersonal Chaos. Each subscale has a score from 15 to 75 where a higher score indicates more severity.
Measured: Baseline, 6 weeks, 24 weeks
Change in family conflict as measured by the Conflict Behavior Questionnaire
A 20-item scale that examines the parent-child relationship using true/false ratings, yielding a total score of 0 to 20. Higher scores This measure is completed by both the youth and the parent(s) or caregiver. Higher scores indicate more severe family conflict.
Measured: Baseline, 6 weeks, 24 weeks
Changes in global impairment as measured by the Columbia Impairment Scale
A 13-item scale designed to measure functioning on a 5 point Likert scale from 0 to 4, yielding a total score of 0 to 52. This measure is completed by both the youth and the parent(s) or caregiver. Higher scores indicate more severe impairment.
Measured: Baseline, 6 weeks, 24 weeks
Changes in affect regulation as measured by the Children's Affective Lability Scale
A 20-item parent-report instrument that measures difficulties with emotion regulation on 5 point Likert scale from 0 to 4, yielding a score from 0 to 80. Higher scores indicate more severe affective lability.
Measured: Baseline, 6 weeks, 24 weeks
Health Care Utilization Survey
A parent-report qualitative interview of a youth's use of available health care services, medication, and the costs associated with those services.
Measured: Baseline, 24 weeks
Usual Care Tracking Survey
A parent-report qualitative interview of a youth's use of available health care services over a 1 week period of time.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Mar 2018
- Primary completionFeb 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Cundill Centre for Child and Youth Depression, SickKids Foundation
- Responsible party
- Principal investigator, Daphne Korczak, The Hospital for Sick Children
- Investigators
- Daphne J Korczak, MD, MSc, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488602
- Sponsor's protocol ID
- 1000056892
- Acronym
- FSPS
- Status last verified
- Mar 2018
- First submitted
- 8 Feb 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617Tracey M, Finkelstein Y, Schachter R, Cleverley K, Monga S, Barwick M, Szatmari P, Moretti ME, Willan A, Henderson J, Korczak DJ. Recruitment of adolescents with suicidal ideation in the emergency department: lessons from a randomized controlled pilot trial of a youth suicide prevention intervention. BMC Med Res Methodol. 2020 Sep 14;20(1):231. doi: 10.1186/s12874-020-01117-5.
PubMed 32928140Korczak DJ, Finkelstein Y, Barwick M, Chaim G, Cleverley K, Henderson J, Monga S, Moretti ME, Willan A, Szatmari P. A suicide prevention strategy for youth presenting to the emergency department with suicide related behaviour: protocol for a randomized controlled trial. BMC Psychiatry. 2020 Jan 14;20(1):20. doi: 10.1186/s12888-019-2422-y.
PubMed 31937274
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03488602
- Acronym / sponsor ID
- FSPS / 1000056892
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Cundill Centre for Child and Youth Depression, SickKids Foundation
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 5 Apr 2018 (actual)
- 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.
This study evaluates whether a Family-centered suicide prevention strategy, when added to usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. Half of the participants will be randomized to receive F-SPS + UC and half will receive EUC.
Detailed description
This is a RCT of a patient- and family-centered suicide prevention intervention added to usual care (F-SPS + UC) for adolescents aged 12 to 18 years who present to the Emergency Department (ED) with suicidal ideation or suicide risk behaviours. The investigators will determine whether the F-SPS + UC intervention is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide.
F-SPS is a 6-week, standardized, manualized outpatient program that teaches participants to the skills to manage suicidal thoughts and impulses effectively. The family component addresses conflictual relationships that may be present in the family as well as improving family communication.
Enhanced usual care consists of 6 weekly telephone calls to ensure that the participant has connected with community resources suggested by the ED team and provide additional resources as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-SPS Intervention | Experimental | Behavioral: F-SPS+UCThis group will receive the F-SPS intervention. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: EUCThis group will receive Enhanced Usual Care (EUC) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 12 to18 years
- Youth presenting in the Emergency Department with acute suicidal ideation or suicide risk behaviour
- SIQ-Jr score ≥ 31
- Parent or caregiver able to communicate in English, or is willing to communicate using a hospital-organized translator, and willing to participate in study
- Living in the greater Toronto area and access to a telephone.
Key exclusion criteria (2 listed)
- Active psychosis or hypomania/mania
- Moderate to severe intellectual disability, autism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-SPS+UCAlso: F-SPS + UCManualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care. | Behavioural | F-SPS Intervention |
| EUCWeekly telephone contact with parents regarding participant health care utilization. Referrals to community mental health resources provided as needed. Participants will continue to receive usual care. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr
Time frame: Screening, 6 weeks, 24 weeks
a 15-item measure self-report of suicide ideation (e.g., thoughts about death and dying) completed by the patient. Items are scored from 0 to 6, yielding a score from 0 to 90. Higher scores indicate more severe suicidal ideation.
7 secondary outcomes
Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised
Time frame: Screening, 6 weeks, 24 weeks
Changes in emotional regulation using the Life Problems Inventory
Time frame: Baseline, 6 weeks, 24 weeks
Change in family conflict as measured by the Conflict Behavior Questionnaire
Time frame: Baseline, 6 weeks, 24 weeks
Changes in global impairment as measured by the Columbia Impairment Scale
Time frame: Baseline, 6 weeks, 24 weeks
Changes in affect regulation as measured by the Children's Affective Lability Scale
Time frame: Baseline, 6 weeks, 24 weeks
Health Care Utilization Survey
Time frame: Baseline, 24 weeks
Usual Care Tracking Survey
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Derived from this study: PubMed 32928140Tracey M, Finkelstein Y, Schachter R, Cleverley K, Monga S, Barwick M, Szatmari P, Moretti ME, Willan A, Henderson J, Korczak DJ. Recruitment of adolescents with suicidal ideation in the emergency department: lessons from a randomized controlled pilot trial of a youth suicide prevention intervention. BMC Med Res Methodol. 2020 Sep 14;20(1):231. doi: 10.1186/s12874-020-01117-5.
- Derived from this study: PubMed 31937274Korczak DJ, Finkelstein Y, Barwick M, Chaim G, Cleverley K, Henderson J, Monga S, Moretti ME, Willan A, Szatmari P. A suicide prevention strategy for youth presenting to the emergency department with suicide related behaviour: protocol for a randomized controlled trial. BMC Psychiatry. 2020 Jan 14;20(1):20. doi: 10.1186/s12888-019-2422-y.
- Individual participant dataSharing planned: Undecided
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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.
Daphne J Korczak, MD, MSc principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-SPS+UC and EUC in people with Suicide and Suicide, Attempted, run by The Hospital for Sick Children 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: status not confirmed, as of the sponsor's last update on 5 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Tracey, MA (4165358501 ext. 201575, matthew.tracey@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr (time frame: Screening, 6 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488602, which also lists 3 linked publications.
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 5 Apr 2018.