NCT04171089

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 27, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2020

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

November 7, 2019

Last Update Submit

January 3, 2024

Conditions

Suicidal IdeationSuicide, Attempted

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the Child-Safety Plan Intervention

    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

    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 Outcomes (5)

  • Child's impulsivity

    Baseline

  • Child's symptoms of irritability

    Baseline

  • Child's attention bias

    Baseline

  • Child's coping skills

    Baseline

  • Child's conceptual level of death

    Baseline

Study Arms (1)

Child-Safety Plan Intervention

EXPERIMENTAL

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

Interventions

Child- Safety Plan InterventionBEHAVIORAL

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.

Child-Safety Plan Intervention

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of a psychotic disorder
  • Intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (9)

  • 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.

    PMID: 19730274RESULT

  • 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.

    PMID: 27096810RESULT

  • 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.

    PMID: 29624113RESULT

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

    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.

    PMID: 29998307RESULT

  • 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.

    PMID: 26828397RESULT

  • 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.

    PMID: 22574736RESULT

  • 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.

    PMID: 16491477RESULT

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

    RESULT

MeSH Terms

Conditions

Suicidal IdeationSuicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Barbara Stanley, PhD

    New York State Psychiatric Institute

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Feasibility and acceptability of the Child Safety Planning Intervention among children and their parents.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 20, 2019

Study Start

December 27, 2019

Primary Completion

October 23, 2020

Study Completion

October 23, 2020

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)