Clinical trial NCT04171089: Suicide Prevention in Prepubertal Children
Official title: Suicide Prevention in Prepubertal Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Suicidal Ideation
Suicide, Attempted
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility and acceptability of the Child Safety Planning Intervention among children and their parents.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of the Child-Safety Plan Intervention
timeFrame: Baseline
measure: Acceptability of the Child-Safety Plan Intervention
timeFrame: Baseline
Secondary outcomes:
measure: Child's impulsivity
timeFrame: Baseline
measure: Child's symptoms of irritability
timeFrame: Baseline
measure: Child's attention bias
timeFrame: Baseline
measure: Child's coping skills
timeFrame: Baseline
measure: Child's conceptual level of death
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Barbara Stanley, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Stanley, B., & Brown, G. K. (2012). Safety planning intervention: a brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice, 19(2), 256-264.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Abela, J. R. Z., Rochon, A., & Vanderbilt, E. (2000). The Children's Response Style Questionnaire (Unpublished questionnaire). Montreal, Canada: McGill University