- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03488602
Focused Suicide Prevention Strategy for Youth (FSPS)
A Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour: A Randomized Controlled Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Matthew Tracey, MA
- Telefonnummer: 201575 4165358501
- E-post: matthew.tracey@sickkids.ca
Studer Kontakt Backup
- Navn: Reva Schachter, MSc
- Telefonnummer: 201469 4165358501
- E-post: reva.schachter@sickkids.ca
Studiesteder
-
-
Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Rekruttering
- Matthew Tracey
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Underetterforsker:
- Myla Moretti, PhD
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Ta kontakt med:
- Matthew Tracey, MA
- Telefonnummer: 201575 4165358501
- E-post: matthew.tracey@sickkids.ca
-
Ta kontakt med:
- Reva Schachter, MSc
- Telefonnummer: 201469 4165358501
- E-post: reva.schachter@sickkids.ca
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Hovedetterforsker:
- Daphne J Korczak, MD, Msc
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Hovedetterforsker:
- Yaron Finkelstein, MD
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Underetterforsker:
- Melanie Barwick, PhD
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Underetterforsker:
- Peter Szatmari, MD
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Underetterforsker:
- Kristin Cleverly, PhD
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Underetterforsker:
- Gloria Chaim, MSW
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Underetterforsker:
- Joanna Henderson, PhD
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Underetterforsker:
- Suneeta Monga, MD
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Underetterforsker:
- David Juurlink, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
Andre navn:
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in suicidal ideation severity as measured by the Suicidal Ideation Questionnaire - Jr
Tidsramme: Screening, 6 weeks, 24 weeks
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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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in suicide related behavior as measured by the Suicide Behavior Questionnaire - Revised
Tidsramme: 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
Tidsramme: 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
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Change in family conflict as measured by the Conflict Behavior Questionnaire
Tidsramme: Baseline, 6 weeks, 24 weeks
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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
Tidsramme: Baseline, 6 weeks, 24 weeks
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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
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Changes in affect regulation as measured by the Children's Affective Lability Scale
Tidsramme: 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
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Health Care Utilization Survey
Tidsramme: Baseline, 24 weeks
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A parent-report qualitative interview of a youth's use of available health care services, medication, and the costs associated with those services.
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Baseline, 24 weeks
|
Usual Care Tracking Survey
Tidsramme: 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.
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Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Daphne J Korczak, MD, MSc, The Hospital for Sick Children
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1000056892
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