Suicide, AttemptedNCT04404322
Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)
A study testing IPT A Suicide Crisis Intervention and Treatment As Usual in people with Suicide, Attempted, run by Rabin Medical Center at 1 site in Israel.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- IPT A Suicide Crisis Intervention and Treatment As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Apr 2018to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- depression symptoms
- suicidal behavior
Who cannot join
- acute medical condition
- intellectual disability
- cognitive impairment
- linguistic limitation
Trial locations and contacts
1 site in 1 country.
Alan APter, Prof contact
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
Petah Tikva
Alan Apter, MD, eapter@clalit.org.il
Alan Apter, MD
About this study
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.
Read the 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.
- Conditions
- Suicide, Attempted
- Being tested
- IPT A Suicide Crisis Intervention, Treatment As Usual
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPT A Suicide Crisis InterventionOther
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.
Treatment As UsualOther
patients receive an integrative combination of psychodynamic, supportive and cognitive behavioral therapy, usually lasting between 10-30 weeks
| Study group | Role | What they receive |
|---|---|---|
| IPT A SCI | Experimental | 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. Receives: Other: IPT A Suicide Crisis Intervention |
| Treatment as usual | Active comparator | TAU patients receive an integrative combination of psychodynamic, supportive and cognitive behavioural therapy, usually lasting between 10-30 weeks. Receives: Other: Treatment As Usual |
| wait list | No intervention | WL patients are monitored by a trained clinician during their waiting period and complete the study questionnaire battery at the parallel time intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Ideation
suicidal ideation [Suicide Ideation Questionnaire (SIQ) (Reynolds, 1987)]
Measured: Change from Baseline to 5 weeks assessment and 4 months assessment
change in Depression
Mood and Feeling Questionnaire (MFQ) (Angold et al., 1995)
Measured: Change from Baseline to 5 weeks assessment and 4 months assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start17 Apr 2018
- Primary completion17 Apr 2022 (estimated)
- Study completion17 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Factorial
- Model description
- Patients are referred to SCMC depression and suicide clinic through the ER, outpatient providers or are self-referred. They undergo an initial evaluation and risk assessment. Following initial evaluation, each subject is assigned to one of three study groups, based on clinical considerations. In this stratified randomization system, the most serious acute cases are generally referred to our ultra-short crisis intervention (IPT- A SCI) and the rest are randomized to either one of the three groups: IPT- A SCI, Treatment as usual (TAU) and waiting list (WL). All participants and their parents complete the questionnaires via a secure electronic interface, with the aid of a trained research assistant. Treatment drop-out rates, thus far, seem low and stand at about 11% for the IPT-A SCI and at about 16% for patients who receive TAU.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan APTER, Prof, Principal investigator, Rabin MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404322
- Sponsor's protocol ID
- 17-0634 RMC
- Status last verified
- Jan 2020
- First submitted
- 4 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)
- ClinicalTrials.gov ID
- NCT04404322
- Acronym / sponsor ID
- 17-0634 RMC
- Conditions
- Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 17 Apr 2022 (estimated)
- Study completion
- 17 Apr 2024 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients are referred to SCMC depression and suicide clinic through the ER, outpatient providers or are self-referred. They undergo an initial evaluation and risk assessment. Following initial evaluation, each subject is assigned to one of three study groups, based on clinical considerations. In this stratified randomization system, the most serious acute cases are generally referred to our ultra-short crisis intervention (IPT- A SCI) and the rest are randomized to either one of the three groups: IPT- A SCI, Treatment as usual (TAU) and waiting list (WL). All participants and their parents complete the questionnaires via a secure electronic interface, with the aid of a trained research assistant. Treatment drop-out rates, thus far, seem low and stand at about 11% for the IPT-A SCI and at about 16% for patients who receive TAU.
| Arm | Type | Receives |
|---|---|---|
| IPT A SCI | Experimental | Other: IPT A Suicide Crisis InterventionThe IPT-A SCI follows the intervention protocol, which includes an intensive phase of 5 weekly 50-minute sessions and 3 follow up personal emails. |
| Treatment as usual | Active comparator | Other: Treatment As UsualTAU patients receive an integrative combination of psychodynamic, supportive and cognitive behavioural therapy, usually lasting between 10-30 weeks. |
| wait list | No intervention | –WL patients are monitored by a trained clinician during their waiting period and complete the study questionnaire battery at the parallel time intervals. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- depression symptoms
- suicidal behavior
Key exclusion criteria (4 listed)
- acute medical condition
- intellectual disability
- cognitive impairment
- linguistic limitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPT A Suicide Crisis InterventionThe 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. | Other | IPT A SCI |
| Treatment As Usualpatients receive an integrative combination of psychodynamic, supportive and cognitive behavioral therapy, usually lasting between 10-30 weeks | Other | Treatment as usual |
Primary outcome
Suicide Ideation
Time frame: Change from Baseline to 5 weeks assessment and 4 months assessment
suicidal ideation [Suicide Ideation Questionnaire (SIQ) (Reynolds, 1987)]
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
Related trials for Suicide, Attempted
Recruiting
Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
Active, not recruiting
DBT Skills Groups for Veterans at High Risk for Suicide Attempt
Suicide, Attempted
Active, not recruiting
Cognitive Reappraisal Intervention for Suicide Prevention (CRISP 70+) for Suicidal Older Adults in a Swedish Geropsychiatric Setting
Suicidal Ideation, Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan APter, Prof contact
Alan APTER, Prof principal investigator
Rabin MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPT A Suicide Crisis Intervention and Treatment As Usual in people with Suicide, Attempted, run by Rabin Medical Center 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liat Haruvi Catalan, Dr (0544948037, liatcatalan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide Ideation (time frame: Change from Baseline to 5 weeks assessment and 4 months assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2020.