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Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study

Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07564583
Enrollment
90
Registered
2026-05-04
Start date
2026-09-09
Completion date
2027-05-31
Last updated
2026-09-09

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

Conditions

Suicidal Behaviors, Suicidal Ideation

Brief summary

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

BEHAVIORALChild - 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 organized into levels (green, yellow, red), each linked to specific action steps.

BEHAVIORALC-SPI+ecological momentary assessment

C-SPI and daily, self-reported use of C-SPI

Sponsors

Columbia University
Lead SponsorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER
American Foundation for Suicide Prevention
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Children aged 6-12 * Active suicidal ideation 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility and acceptability of the C-SPIAt baseline (following the intervention), and at 1 and 3 months follow-upsWhether intervention is clear and perceived as helpful on a scale of 1-5 (higher score indicates better perception of helpfulness)
Utilization of the C-SPIDaily for a month (through EMA), and at 1 and 3 month follow-upsWhether the C-SPI was used or not (0 or 1)
Suicidal behavior1 and 3 monthsWhether suicidal behavior was present and how many times (count variable beginning with zero; higher score indicating worse outcome)
Suicidal ideation severity1 and 3 monthsOn a scale of 0-5 with higher score indicating worse outcome

Secondary

MeasureTime frameDescription
Mental health treatment engagement/service utilization1 and 3 monthsNumber of contact with mental health providers (count variable beginning with zero; higher score indicating better outcome)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026