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Recruitment Status : Withdrawn (Due to COVID-19 Pandemic)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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Study Director:||Barbara Stanley, PhD||New York State Psychiatric Institute|