An interventional study of F-SPS+UC and EUC in Suicide, Suicide, Attempted and Suicidal Ideation, sponsored by The Hospital for Sick Children. Status unknown at 1 site in Canada. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
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.
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.
281 studies on the registry are indexed under Suicide, Attempted; 91 are open to participants now.
This study's planned enrollment of 128 is close to the median of 129 across 224 interventional studies indexed under Suicide, Attempted.
Browse Suicide, Attempted studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Compared within Suicide, Attempted, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will receive the F-SPS intervention.
Behavioral: F-SPS+UC
This group will receive Enhanced Usual Care (EUC)
Behavioral: EUC
Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care.
Also known as: F-SPS + UC
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.
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.
Time frame: Screening, 6 weeks, 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Mar 2018 (actual). Primary completion is estimated for Feb 2020, 23 months after the start.
Of 145 non-industry interventional studies with no phase under Suicide, Attempted, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 56. This study's planned 23 months is below that.
Counting every sponsor, half of 147 studies reached it within 37 months; a quarter within 20 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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