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| Name | Class |
|---|---|
| The Cundill Centre for Child and Youth Depression | UNKNOWN |
| SickKids Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-SPS Intervention | Experimental | This group will receive the F-SPS intervention. |
|
| Enhanced Usual Care (EUC) | Active Comparator | This group will receive Enhanced Usual Care (EUC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-SPS+UC | Behavioral | Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening, 6 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening, 6 weeks, 24 weeks |
| Changes in emotional regulation using the Life Problems Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Tracey, MA | Contact | 4165358501 | 201575 | matthew.tracey@sickkids.ca |
| Reva Schachter, MSc | Contact | 4165358501 | 201469 | reva.schachter@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Daphne J Korczak, MD, MSc | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matthew Tracey | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33884617 | Derived | 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. | |
| 32928140 | Derived | Tracey 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2017 | Mar 19, 2018 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2017 | Mar 19, 2018 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D013406 | Suicide, Attempted |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The research staff responsible for measuring outcomes will be blinded to participants' randomization.
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| EUC | Behavioral | 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. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 |
| 31937274 | Derived | Korczak 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. |