Suicide Prevention in Prepubertal Children

January 3, 2024 updated by: Beth Brodsky, New York State Psychiatric Institute

Suicidal ideation and behaviors are estimated to be as high as 4-16% and 1.5% (respectively) in the general 6-12-year-old population. However, there are currently no validated suicide prevention interventions specifically developed for this population.

This study aims to: (1) test the feasibility and acceptability of the Safety Planning Intervention for prepubertal Children (C-SPI) in 30 children (ages 6-12) who have made a suicide threat, suicidal behavior or reported suicidal ideation, and their parents, and (2) improve the investigator's understanding of suicidal ideation and behaviors in this age group. The results from the current project will be used to further develop the C-SPI, and to develop preliminary guidance and associated policy for clinicians to use.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The Safety Planning Intervention (SPI) is a brief, protocol-driven and individually tailored tool that uses evidence-based practices for suicide prevention. The SPI aims to provide the individual with quick distraction and coping tools to overcome a suicidal crisis without acting upon the suicidal thoughts. The SPI was used in the Treatment for Adolescents Suicide Attempters study in youth 12-19 and has been found to be feasible and acceptable among adult patients and staff as well as among clinicians who work with adolescents. Its effectiveness in reducing suicide risk among veterans has also been confirmed. The SPI could be a good fit for children, as it uses concrete ways for the person to recognize their reaction, as well as concrete methods to cope with distress, which fits with the developmental stage of prepubertal children. Moreover, the collaborative way in which the personal safety plan is tailored to the suicidal person will allow the engagement of the child in the intervention. The SPI is an intervention that is relatively easy to administer and, therefore, if found to be appropriate for this age group, it could be implemented in different child-focused settings, including schools. The aim of the study is to evaluate the acceptability and feasibility of the Safety Planning Intervention for prepubertal Children's (C-SPI) among suicidal children and their parents. Additionally, children will be interviewed and be assessed for impulsivity, attention bias, irritability and coping skills.

Study Type

Interventional

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 Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

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 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Suicidal thoughts or threats in the last six month or suicidal behavior in lifetime
  • The child and his parent/guardian are English speakers
  • Having a parent /guardian consent to the child participating in this study
  • The clinician confirmed that the parents are suitable to take part in the intervention

Exclusion Criteria:

  • Diagnosis of a psychotic disorder
  • Intellectual disability

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Child-Safety Plan Intervention
A Child Safety Plan to prevent suicidal behavior will be developed with the children and their parents. The parents and child will complete feasibility and acceptability questionnaires.
Behavioral: Child- Safety Plan Intervention
The intervention includes recognizing and knowing the individual's warning signs for a suicidal crisis, their personal coping/distraction skills, people to contact, as well as a restriction of the means to hurt oneself.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the Child-Safety Plan Intervention
Time Frame: Baseline
The Patient Satisfaction Survey is a 12-item self-report questionnaire (child and parents versions), half of the items assess the feasibility of the child-safety plan intervention in this age group.
Baseline
Acceptability of the Child-Safety Plan Intervention
Time Frame: Baseline
The Patient Satisfaction Survey is a 12-item self-report questionnaire (child and parents versions), half of the items assess the acceptability of the child-safety plan intervention in this age group.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child's impulsivity
Time Frame: Baseline
Child's impulsivity will be assessed using the "Go/No-go" computer task. The Go/No go is a measure of inhibitory control. An adaptation of the original Go/No go paradigm will be used, adjusted for elementary school children.
Baseline
Child's symptoms of irritability
Time Frame: Baseline
Child's symptoms of irritability will be assessed using the Affective Reactivity Index (ARI). The ARI is a seven-item scale that is both parent- and child-reported. The ARI asks about symptoms of irritability in the previous 6 months and includes an item assessing impairment due to irritability.
Baseline
Child's attention bias
Time Frame: Baseline
Child's attention bias will be evaluated using the Emotional picture dot prob computer task. The Emotional picture dot prob task is a spatially oriented, motivated attention task that capture the preattentive mechanism that automatically directs attention toward biologically relevant aversive stimuli, providing an indirect index of emotional reactivity.
Baseline
Child's coping skills
Time Frame: Baseline
Child's coping skills will be assessed using the Children's Response Styles Questionnaire. The Children's Response Styles Questionnaire consists of 25 items, each of which describes a particular response to symptoms of depression. For each item, children are asked to indicate how often they respond in this way when they are feeling sad. The items are grouped into two scales: (1) Ruminative Response subscale; and (2) Distracting Response subscale.
Baseline
Child's conceptual level of death
Time Frame: Baseline
Child's conceptual level of death will be assessed using the Death interview for children. The Death interview for children is an interview comprised of open-ended questions. It has been widely used to assess children's understanding of death as a biological event.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Study Director: Barbara Stanley, PhD, New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 27, 2019

Primary Completion (Actual)

October 23, 2020

Study Completion (Actual)

October 23, 2020

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 18, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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