- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404322
Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)
May 26, 2020 updated by: Rabin Medical Center
To address the critical need in crisis intervention for children and adolescents at suicidal risk the investigators developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT).
The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In recent years, suicidal behaviors have shown substantial increase worldwide.
This trend is also prominent in Israel and has led to a dramatic increase in mental health treatment demand resulting in long wait times and low treatment acceptance rate.
To address the critical need in crisis intervention for children and adolescents at suicidal risk, the investigators developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT).
IPT is an evidence-based intervention for various psychopathologies among different age groups.
The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liat Haruvi Catalan, Dr
- Phone Number: 0544948037
- Email: liatcatalan@gmail.com
Study Contact Backup
- Name: Alan APter, Prof
- Email: asapter@gmail.com
Study Locations
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-
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Petach Tikva, Israel
- Recruiting
- Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
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Contact:
- Alan Apter, MD
- Email: eapter@clalit.org.il
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Principal Investigator:
- Alan Apter, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- depression symptoms
- suicidal behavior
Exclusion Criteria:
- acute medical condition
- intellectual disability
- cognitive impairment
- linguistic limitation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IPT A SCI
The IPT-A SCI follows the intervention protocol, which includes an intensive phase of 5 weekly 50-minute sessions and 3 follow up personal emails.
|
The intervention is comprised of five weekly sessions followed by monthly emails to the patients and their parents over a period of three months.
The first session is aimed at introducing the intervention, assessing depression and suicidal risk and building a safety plan.
The safety plan consists of a prioritized list of coping strategies that the patient can use when suicidal risk is increased.
The second session is focused on reviewing the patient's interpersonal relationships (using the closeness circle and interpersonal inventory) and conceptualizing the interpersonal problem area.
Sessions 3-4 focus on developing and practicing interpersonal, emotional and behavioral coping strategies relevant for suicidal risk.
Lastly, in session 5, patient and therapist go over the process and main issues which were worked on, emphasizing relapse prevention by going back to the safety plan.
First and fifth sessions always involve the parents.
|
Active Comparator: Treatment as usual
TAU patients receive an integrative combination of psychodynamic, supportive and cognitive behavioural therapy, usually lasting between 10-30 weeks.
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patients receive an integrative combination of psychodynamic, supportive and cognitive behavioral therapy, usually lasting between 10-30 weeks
|
No Intervention: wait list
WL patients are monitored by a trained clinician during their waiting period and complete the study questionnaire battery at the parallel time intervals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide Ideation
Time Frame: Change from Baseline to 5 weeks assessment and 4 months assessment
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suicidal ideation [Suicide Ideation Questionnaire (SIQ) (Reynolds, 1987)]
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Change from Baseline to 5 weeks assessment and 4 months assessment
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change in Depression
Time Frame: Change from Baseline to 5 weeks assessment and 4 months assessment
|
Mood and Feeling Questionnaire (MFQ) (Angold et al., 1995)
|
Change from Baseline to 5 weeks assessment and 4 months assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan APTER, Prof, Rabin MC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2018
Primary Completion (Anticipated)
April 17, 2022
Study Completion (Anticipated)
April 17, 2024
Study Registration Dates
First Submitted
May 4, 2020
First Submitted That Met QC Criteria
May 26, 2020
First Posted (Actual)
May 27, 2020
Study Record Updates
Last Update Posted (Actual)
May 27, 2020
Last Update Submitted That Met QC Criteria
May 26, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0634 RMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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