NCT04404322

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2024

Completed
Last Updated

May 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4 years

First QC Date

May 4, 2020

Last Update Submit

May 26, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Suicide Ideation

    suicidal ideation \[Suicide Ideation Questionnaire (SIQ) (Reynolds, 1987)\]

    Change from Baseline to 5 weeks assessment and 4 months assessment

  • change in Depression

    Mood and Feeling Questionnaire (MFQ) (Angold et al., 1995)

    Change from Baseline to 5 weeks assessment and 4 months assessment

Study Arms (3)

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.

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.

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.

Interventions

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.

IPT A SCI

patients receive an integrative combination of psychodynamic, supportive and cognitive behavioral therapy, usually lasting between 10-30 weeks

Treatment as usual

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • depression symptoms
  • suicidal behavior

You may not qualify if:

  • acute medical condition
  • intellectual disability
  • cognitive impairment
  • linguistic limitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Alan APTER, Prof

    Rabin MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liat Haruvi Catalan, Dr

CONTACT

Alan APter, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 27, 2020

Study Start

April 17, 2018

Primary Completion

April 17, 2022

Study Completion

April 17, 2024

Last Updated

May 27, 2020

Record last verified: 2020-01

Locations