Focused Suicide Prevention Strategy for Youth (FSPS)
28 mars 2018 uppdaterad av: Daphne Korczak, The Hospital for Sick Children
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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
128
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G 1X8
- Rekrytering
- Matthew Tracey
-
Underutredare:
- Myla Moretti, PhD
-
Kontakt:
- Matthew Tracey, MA
- Telefonnummer: 201575 4165358501
- E-post: matthew.tracey@sickkids.ca
-
Kontakt:
- Reva Schachter, MSc
- Telefonnummer: 201469 4165358501
- E-post: reva.schachter@sickkids.ca
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Huvudutredare:
- Daphne J Korczak, MD, Msc
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Huvudutredare:
- Yaron Finkelstein, MD
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Underutredare:
- Melanie Barwick, PhD
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Underutredare:
- Peter Szatmari, MD
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Underutredare:
- Kristin Cleverly, PhD
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Underutredare:
- Gloria Chaim, MSW
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Underutredare:
- Joanna Henderson, PhD
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Underutredare:
- Suneeta Monga, MD
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Underutredare:
- David Juurlink, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Active psychosis or hypomania/mania
- Moderate to severe intellectual disability, autism.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: F-SPS Intervention
This group will receive the F-SPS intervention.
|
Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks. Participants will continue to receive usual care.
Andra namn:
|
|
Aktiv komparator: Enhanced Usual Care (EUC)
This group will receive Enhanced Usual Care (EUC)
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr
Tidsram: 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.
|
Screening, 6 weeks, 24 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised
Tidsram: Screening, 6 weeks, 24 weeks
|
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
Tidsram: Baseline, 6 weeks, 24 weeks
|
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
Tidsram: Baseline, 6 weeks, 24 weeks
|
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
|
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Changes in global impairment as measured by the Columbia Impairment Scale
Tidsram: Baseline, 6 weeks, 24 weeks
|
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
Tidsram: Baseline, 6 weeks, 24 weeks
|
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
Tidsram: Baseline, 24 weeks
|
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
|
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Usual Care Tracking Survey
Tidsram: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Daphne J Korczak, MD, MSc, The Hospital for Sick Children
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2018
Primärt slutförande (Förväntat)
1 februari 2020
Avslutad studie (Förväntat)
1 juli 2020
Studieregistreringsdatum
Först inskickad
8 februari 2018
Först inskickad som uppfyllde QC-kriterierna
28 mars 2018
Första postat (Faktisk)
5 april 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 april 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 mars 2018
Senast verifierad
1 mars 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1000056892
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