Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Child - Safety Planning Intervention, C-SPI+ecological momentary assessment.
- Who it may be relevant to
- Registry conditions: Suicidal Ideation, Suicidal Behaviors. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this study is to finalize a version of the Safety Planning Intervention suitable for 6-12-year-old children. This intervention provides individuals with strategies to reduce the risk of suicidal behavior. The main questions it aims to answer are: 1. Does the intervention appear clear and acceptable to the children and caregivers? 2. Does the intervention work to reduce suicidal behavior? Researchers will compare the group that received the intervention to a group that did not receive it, and to a group that received it and reported daily on its use. Participants will: 1. Children and parents will respond to questions in an interview and through self-reports in an in-person meeting 2. Children and parents will receive the intervention (those in the intervention groups) 3. Parents will report daily for one month (only those in the intervention + reporting group) 4. Children and parents will meet with the study team through a video call at 1 and 3 months from the first meeting for an interview.
Interventions
- Behavioral Child - Safety Planning Intervention
The Child Safety Planning Intervention (C-SPI) provides psychoeducation to children and caregivers about emotions, thoughts, and behaviors, emphasizing how these interact and change over time. Suicidal thoughts are framed as temporary reactions to triggers that can be recognized and managed. The intervention reviews a recent suicidal crisis to identify triggers, thoughts, feelings, and behaviors, which are then used to help the child recognize warning signs in the future. These signs are organiz - Behavioral C-SPI+ecological momentary assessment
C-SPI and daily, self-reported use of C-SPI
Primary outcome measures
- Feasibility and acceptability of the C-SPI [Time frame: At baseline (following the intervention), and at 1 and 3 months follow-ups]
- Utilization of the C-SPI [Time frame: Daily for a month (through EMA), and at 1 and 3 month follow-ups]
- Suicidal behavior [Time frame: 1 and 3 months]
- Suicidal ideation severity [Time frame: 1 and 3 months]
Secondary outcome measures (1)
- Mental health treatment engagement/service utilization [Time frame: 1 and 3 months]
Eligibility criteria
Inclusion criteria
- Children aged 6-12
- Suicidal ideation with a plan or intent or a suicidal behavior in the last month
- The child and their caregiver are English speakers
- The child will be in an outpatient treatment at CHOP at the time of enrollment and baseline procedures
Exclusion criteria
- Child received a diagnosis of a psychotic disorder or intellectual disability
- Child is suffering from active mania
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Children Hospital of Philadelphia — Philadelphia
Identifiers
NCT: NCT07564583 · AAAV3403