Suicide Prevention in Prepubertal Children

NCT ID: NCT04171089

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-27
• Study Completion Date: 2020-10-23

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.

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.

Conditions

Suicidal Ideation; Suicide, Attempted

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Child- Safety Plan Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Beth Brodsky

Associate Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Stanley, PhD

Role: STUDY_DIRECTOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

Brent DA, Greenhill LL, Compton S, Emslie G, Wells K, Walkup JT, Vitiello B, Bukstein O, Stanley B, Posner K, Kennard BD, Cwik MF, Wagner A, Coffey B, March JS, Riddle M, Goldstein T, Curry J, Barnett S, Capasso L, Zelazny J, Hughes J, Shen S, Gugga SS, Turner JB. The Treatment of Adolescent Suicide Attempters study (TASA): predictors of suicidal events in an open treatment trial. J Am Acad Child Adolesc Psychiatry. 2009 Oct;48(10):987-996. doi: 10.1097/CHI.0b013e3181b5dbe4.

Reference Type: RESULT

PMID: 19730274 (View on PubMed)

Chesin MS, Stanley B, Haigh EA, Chaudhury SR, Pontoski K, Knox KL, Brown GK. Staff Views of an Emergency Department Intervention Using Safety Planning and Structured Follow-Up with Suicidal Veterans. Arch Suicide Res. 2017 Jan 2;21(1):127-137. doi: 10.1080/13811118.2016.1164642. Epub 2016 Apr 20.

Reference Type: RESULT

PMID: 27096810 (View on PubMed)

Reyes-Portillo JA, McGlinchey EL, Toso-Salman J, Chin EM, Fisher PW, Mufson L. Clinician Experience and Attitudes Toward Safety Planning with Adolescents at Risk for Suicide. Arch Suicide Res. 2019 Apr-Jun;23(2):222-233. doi: 10.1080/13811118.2018.1456382. Epub 2019 Jan 12.

Reference Type: RESULT

PMID: 29624113 (View on PubMed)

Stanley, B., & Brown, G. K. (2012). Safety planning intervention: a brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice, 19(2), 256-264.

Reference Type: RESULT

Stanley B, Brown GK, Brenner LA, Galfalvy HC, Currier GW, Knox KL, Chaudhury SR, Bush AL, Green KL. Comparison of the Safety Planning Intervention With Follow-up vs Usual Care of Suicidal Patients Treated in the Emergency Department. JAMA Psychiatry. 2018 Sep 1;75(9):894-900. doi: 10.1001/jamapsychiatry.2018.1776.

Reference Type: RESULT

PMID: 29998307 (View on PubMed)

Stanley B, Chaudhury SR, Chesin M, Pontoski K, Bush AM, Knox KL, Brown GK. An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. Psychiatr Serv. 2016 Jun 1;67(6):680-3. doi: 10.1176/appi.ps.201500082. Epub 2016 Feb 1.

Reference Type: RESULT

PMID: 26828397 (View on PubMed)

Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012 Nov;53(11):1109-17. doi: 10.1111/j.1469-7610.2012.02561.x. Epub 2012 May 10.

Reference Type: RESULT

PMID: 22574736 (View on PubMed)

Kimonis ER, Frick PJ, Fazekas H, Loney BR. Psychopathy, aggression, and the processing of emotional stimuli in non-referred girls and boys. Behav Sci Law. 2006;24(1):21-37. doi: 10.1002/bsl.668.

Reference Type: RESULT

PMID: 16491477 (View on PubMed)

Abela, J. R. Z., Rochon, A., & Vanderbilt, E. (2000). The Children's Response Style Questionnaire (Unpublished questionnaire). Montreal, Canada: McGill University

Reference Type: RESULT

Other Identifiers

7838

Identifier Type: -

Identifier Source: org_study_id