- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07627243
Brief Crisis Therapy for Suicidal Children and Adolescents (IPT-A-SCI)
Ultra-Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI): Understanding Mechanisms of Change
The goal of this clinical trial is to learn if the Ultra-Brief Interpersonal Psychotherapy for Adolescents with Suicidal Ideation (IPT-A-SCI) works to reduce suicidal thoughts and behaviors in children and adolescents. The study will also examine whether treatment effects continue after treatment ends and whether some participants benefit more from the intervention than others. The main questions it aims to answer are:
Does IPT-A-SCI reduce suicidal thoughts and behaviors in children and adolescents? Do the effects of IPT-A-SCI continue three months after treatment ends? Do some children and adolescents benefit more from IPT-A-SCI than others?
Participants will:
Receive IPT-A-SCI treatment consisting of five weekly sessions Complete questionnaires before treatment, during treatment, at the end of treatment, and three months after treatment ends Have their parents complete questionnaires at the same time points
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
IPT-A-SCI (Ultra-Brief Crisis Interpersonal Psychotherapy for Adolescents with Suicidal Ideation) is a manualized five-session crisis intervention based on Interpersonal Psychotherapy (IPT) principles.
IPT-A-SCI is designed for children and adolescents aged 8-18 presenting with suicidal ideation or behavior. The intervention combines IPT principles with the Safety Planning Intervention and includes a three-month post-intervention contact protocol.
This is a single-group, pre-post interventional study with repeated measures collected at four time points. All participants will receive the IPT-A-SCI intervention. There is no control or comparison group in this study, as the research focuses on within-person mechanisms of change and moderators of treatment response rather than between-group comparisons.
Participants will be recruited from the Child and Adolescent Clinic at Geha Mental Health Center through emergency room referrals, outpatient providers, and treating therapists at the clinic. Initial evaluation and suicide risk assessment will be conducted by experienced clinical staff according to established clinical guidelines for suicide risk assessment in adolescents.
Up to 120 participants will be enrolled over an estimated two-year recruitment period.
During the three months following treatment, participants will receive three personalized emails at 2 weeks, 1 month, and 2 months post-treatment. A follow-up session will take place three months after treatment completion. Psychiatric or psychosocial treatment may continue as usual during IPT-A-SCI.
Statistical Analysis Plan:
Three complementary analytic frameworks will be used:
- Modeling within-person change across therapy
- Examining associations between changes in proposed mechanisms of change and changes in suicidality
- Identifying participant characteristics associated with differential treatment response Individual Growth Curve Modeling (IGCM) will be used to examine trajectories of change across the four assessment time points for proposed mechanisms of change, including hope, perceived social support, emotional processing, family conflict, and interpersonal functioning.
Latent Change Score (LCS) modeling will be used to assess changes in suicidal ideation and related clinical outcomes from baseline to post-treatment and follow-up. Associations between changes in proposed mechanisms and changes in suicidality will be examined to identify factors that may contribute to treatment effectiveness.
Linear Mixed-Effects Models (LMMs) will be used to examine whether treatment effectiveness varies according to baseline participant characteristics, including initial suicide risk severity and other demographic and clinical variables. These analyses will identify moderators of treatment response and determine which participants derive the greatest benefit from the intervention.
Missing data will be handled in accordance with established best practices for longitudinal clinical research. The analytic approaches described above accommodate missing data under missing-at-random assumptions.
Data Collection and Management:
- Questionnaires will be completed by participants and parents at all assessment time points.
- The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered by clinicians during treatment sessions.
- A unique trial identification number will be assigned at recruitment and used across all study materials.
- All study data will be retained in accordance with Good Clinical Practice (GCP) guidelines.
Safety Monitoring and Ethical Considerations:
This study focuses on children and adolescents at risk for suicide. The Child and Adolescent Clinic at Geha Mental Health Center is located on the grounds of a psychiatric hospital with a 24/7 emergency room. Participants presenting with acute suicidal crisis during the study may be referred immediately for emergency psychiatric evaluation.
All treating clinicians are trained in suicide risk assessment and management. Adverse events, including worsening suicidal ideation or behavior, will be documented and reported in accordance with Helsinki Committee requirements and Good Clinical Practice guidelines.
No formal Data Safety Monitoring Board (DSMB) is in place for this study given its single-site naturalistic design. Clinical oversight will be provided through routine supervision and case conferencing.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Chamutal Saragusty, MA
- Telefonní číslo: 972-52-3400936
- E-mail: yanivchamutal@gmail.com
Studijní místa
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Petah Tikva, Izrael
- Geha Mental Health Center
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Kontakt:
- Chamutal Saragusty, MA
- Telefonní číslo: 972-52-3400936
- E-mail: yanivchamutal@gmail.com
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Vrchní vyšetřovatel:
- Chamutal Saragusty, MA
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Children and adolescents aged 8-18 years presenting with suicidal ideation or behavior
- Suicide risk assessment indicating suitability for outpatient treatment,
- Fluency in Hebrew
- Ability to attend five weekly treatment sessions
- Written informed consent provided by parents or legal guardians
- Written informed assent/consent provided by participants in accordance with age and local ethical regulations
Exclusion Criteria:
- Acute medical or psychiatric condition requiring immediate inpatient treatment
- Linguistic, developmental, neurological, or intellectual limitations that prevent understanding of the treatment protocol or study procedures
- Inability to participate in outpatient psychotherapy
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: IPT-A-SCI
Participants will receive the IPT-A-SCI intervention consisting of five weekly sessions of ultra-brief interpersonal psychotherapy combined with safety planning for suicidal ideation and behavior.
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Manualized ultra-brief interpersonal psychotherapy intervention combined with safety planning for children and adolescents with suicidal ideation or behavior.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Severity of Suicidal Ideation
Časové okno: Baseline to 3-month follow-up
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Change in severity of suicidal ideation and behavior assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS).
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Baseline to 3-month follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Intensity of Suicidal Ideation
Časové okno: Baseline to 3-month follow-up
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Change in intensity of suicidal ideation assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) ideation intensity scale.
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Baseline to 3-month follow-up
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Change in Depressive Symptoms
Časové okno: Baseline to 3-month follow-up
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Change in depressive symptoms assessed using the Short Mood and Feelings Questionnaire (SMFQ).
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Baseline to 3-month follow-up
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Change in Perceived Social Support
Časové okno: Baseline to 3-month follow-up
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Change in perceived social support assessed using the Multidimensional Scale of Perceived Social Support (MSPSS).
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Baseline to 3-month follow-up
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Change in Emotional Processing (Alexithymia)
Časové okno: Baseline to 3-month follow-up
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Change in emotional processing and alexithymia assessed using the Toronto Alexithymia Scale (TAS-20).
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Baseline to 3-month follow-up
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Change in Hope
Časové okno: Baseline to 3-month follow-up
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Change in hope assessed using the Children's Hope Scale (CHS).
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Baseline to 3-month follow-up
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Change in Family Conflict and Interpersonal Stress
Časové okno: Baseline to 3-month follow-up
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Change in family conflict and interpersonal stress assessed using the Family Environment Scale (FES) conflict subscale.
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Baseline to 3-month follow-up
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Change in Irritability and Emotional Dysregulation
Časové okno: Baseline to 3-month follow-up
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Change in irritability and emotional dysregulation assessed using the parent-report TIDES-13 questionnaire.
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Baseline to 3-month follow-up
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Change in Interpersonal and Social Functioning
Časové okno: Baseline to 3-month follow-up
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Change in interpersonal and social functioning assessed using EFORTS social routine measures.
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Baseline to 3-month follow-up
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Behavioral and Emotional Problems at Baseline
Časové okno: Baseline only
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Behavioral and emotional problems assessed using the parent-report Child Behavior Checklist (CBCL).
This measure will be used for descriptive and covariate analyses.
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Baseline only
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Chamutal Saragusty, MA, Geha Mental Health Center and Tel Aviv University
Publikace a užitečné odkazy
Obecné publikace
- Stanley B, Brown GK. Safety Planning Intervention: A Brief Intervention to Mitigate Suicide Risk. Cogn Behav Pract. 2012;19(2):256-264. doi:10.1016/j.cbpra.2011.01.001.
- Itzhaky L, Davaasambuu S, Ellis SP, Cisneros-Trujillo S, Hannett K, Scolaro K, Stanley BH, Mann JJ, Wainberg ML, Oquendo MA, Sublette ME. Twenty-six years of psychosocial interventions to reduce suicide risk in adolescents: Systematic review and meta-analysis. J Affect Disord. 2022 Mar 1;300:511-531. doi: 10.1016/j.jad.2021.12.094. Epub 2021 Dec 31.
- Lipsitz JD, Markowitz JC. Mechanisms of change in interpersonal therapy (IPT). Clin Psychol Rev. 2013 Dec;33(8):1134-47. doi: 10.1016/j.cpr.2013.09.002. Epub 2013 Sep 25.
- Adini-Spigelman E, Gvion Y, Haruvi Catalan L, Barzilay S, Apter A, Brunstein Klomek A. Comparative Effectiveness of Ultra-Brief, IPT-A Based Crisis Intervention for Suicidal Children and Adolescents. Arch Suicide Res. 2024 Oct-Dec;28(4):1249-1262. doi: 10.1080/13811118.2023.2298499. Epub 2024 Jan 3.
- Haruvi Catalan L, Levis Frenk M, Adini Spigelman E, Engelberg Y, Barzilay S, Mufson L, Apter A, Benaroya Milshtein N, Fennig S, Klomek AB. Ultra-Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI) Pilot Study Results. Front Psychiatry. 2020 Dec 9;11:553422. doi: 10.3389/fpsyt.2020.553422. eCollection 2020.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0014-21-GEH
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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