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Suicidal IdeationIPT-A-SCINCT07627243

Brief Crisis Therapy for Suicidal Children and Adolescents

A study testing IPT-A-SCI in people with Suicidal Ideation and Suicidal Behavior, run by Tel Aviv University at 1 site in Israel.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 to 18 years
Conditions the study is for
Suicidal Ideation, Suicidal Behavior
What is being tested?
IPT-A-SCI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteIsrael
Study dates
Jun 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chamutal Saragusty, MA contact

972-52-3400936

yanivchamutal@gmail.com

Israel1 site
  • Geha Mental Health Center

    Petah Tikva

    Chamutal Saragusty, MA, 972-52-3400936, yanivchamutal@gmail.com

    Chamutal Saragusty, MA

Other trials in Israel

About this study

Official title: 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?

Read more

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

Read the detailed description

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:

  1. Modeling within-person change across therapy
  2. Examining associations between changes in proposed mechanisms of change and changes in suicidality
  3. 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.

Being tested
IPT-A-SCI
Keywords
suicidal ideation, suicidal behavior, Interpersonal psychotherapy, children, adolescents, Suicide prevention, Safety planning, Brief intervention
Medical subject headings
Suicidal Ideation, Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPT-A-SCIBehavioural

    Manualized ultra-brief interpersonal psychotherapy intervention combined with safety planning for children and adolescents with suicidal ideation or behavior.

Study groups in NCT07627243
Study groupRoleWhat they receive
IPT-A-SCIExperimentalParticipants 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.
Receives: Behavioral: IPT-A-SCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Severity of Suicidal Ideation

    Change in severity of suicidal ideation and behavior assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS assesses the severity of suicidal ideation and the occurrence of suicidal behaviors. The suicidal ideation severity score ranges from 1 to 5, with higher scores indicating greater severity of suicidal ideation.

    Measured: Baseline to 3-month follow-up

Secondary outcomes (9)
  1. Change in Intensity of Suicidal Ideation

    Change in intensity of suicidal ideation assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) ideation intensity scale. The C-SSRS assesses the intensity of the most severe suicidal ideation endorsed by evaluating five dimensions: frequency, duration, controllability, deterrents, and reasons for ideation. Total scores range from 0 to 25, with a score of 0 assigned when no suicidal ideation is endorsed and scores from 2 to 25 indicating increasing intensity of suicidal ideation. Higher scores indicate more intense suicidal ideation and a worse outcome.

    Measured: Baseline to 3-month follow-up

  2. Change in Depressive Symptoms

    Change in depressive symptoms assessed using the Short Mood and Feelings Questionnaire (SMFQ). Scores range from 0 to 26, with higher scores indicating greater depressive symptom severity and a worse outcome.

    Measured: Baseline to 3-month follow-up

  3. Change in Perceived Social Support

    Change in perceived social support assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). Scores range from 12 to 84, with higher scores indicating greater perceived social support and a better outcome.

    Measured: Baseline to 3-month follow-up

  4. Change in Emotional Processing (Alexithymia)

    Change in emotional processing and alexithymia assessed using the Toronto Alexithymia Scale (TAS-20). Scores range from 20 to 100, with higher scores indicating greater difficulty identifying and describing emotions (greater alexithymia) and a worse outcome.

    Measured: Baseline to 3-month follow-up

  5. Change in Hope

    Change in hope assessed using the Children's Hope Scale (CHS). Scores range from 6 to 36, with higher scores indicating greater hopefulness and a better outcome.

    Measured: Baseline to 3-month follow-up

  6. Change in Family Conflict and Interpersonal Stress

    Change in family conflict and interpersonal stress assessed using the Family Environment Scale (FES) conflict subscale. Scores range from 0 to 9, with higher scores indicating greater family conflict and a worse outcome.

    Measured: Baseline to 3-month follow-up

  7. Change in Irritability and Emotional Dysregulation

    Change in irritability and emotional dysregulation assessed using the parent-report TIDES-13 questionnaire. Total scores range from 13 to 91, with higher scores indicating greater irritability and emotional dysregulation and a worse outcome.

    Measured: Baseline to 3-month follow-up

  8. Change in Interpersonal and Social Functioning

    Change in interpersonal and social functioning assessed using EFORTS social routine measures. Scores range from 0 to 5. with higher scores indicating better social routine functioning and executive functioning in daily activities and therefore a better outcome.

    Measured: Baseline to 3-month follow-up

  9. Behavioral and Emotional Problems at Baseline

    Behavioral and emotional problems assessed using the parent-report Child Behavior Checklist (CBCL). This measure will be used for descriptive and covariate analyses. Raw scores vary according to age and sex and are converted to standardized T-scores. Higher T-scores indicate greater emotional and behavioral problems and a worse outcome.

    Measured: Baseline only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive the IPT-A-SCI intervention. This is a single-group pre-post study with repeated assessments conducted before treatment, during treatment, after treatment completion, and at 3-month follow-up.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07627243
Sponsor's protocol ID
0014-21-GEH
Acronym
IPT-A-SCI
Status last verified
Jun 2026
First submitted
30 May 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34974074
  • 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.

    PubMed 24100081
  • 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.

    PubMed 38169321
  • 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.

    PubMed 33362595

Questions about this trial

What is this clinical trial studying?

A study testing IPT-A-SCI in people with Suicidal Ideation and Suicidal Behavior, run by Tel Aviv University at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chamutal Saragusty, MA (972-52-3400936, yanivchamutal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Severity of Suicidal Ideation (time frame: Baseline to 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07627243, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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