- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Chamutal Saragusty, MA
- Numer telefonu: 972-52-3400936
- E-mail: yanivchamutal@gmail.com
Lokalizacje studiów
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Petah Tikva, Izrael
- Geha Mental Health Center
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Kontakt:
- Chamutal Saragusty, MA
- Numer telefonu: 972-52-3400936
- E-mail: yanivchamutal@gmail.com
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Główny śledczy:
- Chamutal Saragusty, MA
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Severity of Suicidal Ideation
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Intensity of Suicidal Ideation
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Chamutal Saragusty, MA, Geha Mental Health Center and Tel Aviv University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 0014-21-GEH
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na IPT-A-SCI
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Shira BarzilaySchneider Children's Medical Center, IsraelRekrutacyjnyMyśli i zachowania samobójczeIzrael
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New York State Psychiatric InstituteZakończonyDepresja jednobiegunowa | DystymiaStany Zjednoczone
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University of RochesterNational Institute of Mental Health (NIMH)Zakończony
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New York State Psychiatric InstituteZakończonyDepresjaStany Zjednoczone
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New York State Psychiatric InstituteZakończony
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New York State Psychiatric InstituteZakończonyCiężkie zaburzenie depresyjne | DystymiaStany Zjednoczone
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Boston CollegeJeszcze nie rekrutacjaMyśli samobójcze | Objawy depresyjne | Zdrowie psychiczne nastolatkówStany Zjednoczone
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Linnaeus UniversityLinkoeping UniversityRekrutacyjny
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University College, LondonJeszcze nie rekrutacjaZapalenie | Choroby przyzębiaZjednoczone Królestwo
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Johns Hopkins UniversityPatient-Centered Outcomes Research Institute; Children's Hospital of Philadelphia i inni współpracownicyRekrutacyjnySamobójstwo, próba | Samobójstwo | Pomysły samobójcze | Zapobieganie samobójstwomStany Zjednoczone