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Suicide Prevention in Prepubertal Children

Suicide Prevention in Prepubertal Children

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04171089
Enrollment
0
Registered
2019-11-20
Start date
2019-12-27
Completion date
2020-10-23
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Ideation, Suicide, Attempted

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.

Interventions

BEHAVIORALChild- 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.

Sponsors

New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Feasibility and acceptability of the Child Safety Planning Intervention among children and their parents.

Eligibility

Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the Child-Safety Plan InterventionBaselineThe 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.
Acceptability of the Child-Safety Plan InterventionBaselineThe 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

MeasureTime frameDescription
Child's attention biasBaselineChild'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.
Child's impulsivityBaselineChild'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.
Child's conceptual level of deathBaselineChild'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.
Child's coping skillsBaselineChild'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.
Child's symptoms of irritabilityBaselineChild'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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026