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Suicide Prevention in Prepubertal Children

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ClinicalTrials.gov Identifier: NCT04171089
Recruitment Status : Withdrawn (Due to COVID-19 Pandemic)
First Posted : November 20, 2019
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Barbara Stanley, New York State Psychiatric Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Suicidal Ideation Suicide, Attempted Behavioral: Child- Safety Plan Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility and acceptability of the Child Safety Planning Intervention among children and their parents.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Suicide Prevention in Prepubertal Children
Actual Study Start Date : December 27, 2019
Actual Primary Completion Date : October 23, 2020
Actual Study Completion Date : October 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171089


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Study Director: Barbara Stanley, PhD New York State Psychiatric Institute
Publications of Results:
Stanley, B., & Brown, G. K. (2012). Safety planning intervention: a brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice, 19(2), 256-264.
Abela, J. R. Z., Rochon, A., & Vanderbilt, E. (2000). The Children's Response Style Questionnaire (Unpublished questionnaire). Montreal, Canada: McGill University

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Responsible Party: Barbara Stanley, Professor of Medical Psychology, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT04171089    
Other Study ID Numbers: 7838
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms