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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Suicidal Ideation; Suicidal Behaviors
• Intervention / Treatment: Behavioral: Child - Safety Planning Intervention; Behavioral: C-SPI+ecological momentary assessment

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual (TAU)
Experimental: Child-safety planning intervention (C-SPI) + TAU; Child - Safety Planning Intervention	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 organized into levels (green, yellow, red), each linked to specific action steps.; Other Names: C-SPI
Other: C-SPI + TAU + ecological momentary assessment; Child - Safety Planning Intervention and daily reporting	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 organized into levels (green, yellow, red), each linked to specific action steps.; Other Names: C-SPI; Behavioral: C-SPI+ecological momentary assessment; C-SPI and daily, self-reported use of C-SPI; Other Names: EMA; C-SPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and acceptability of the C-SPI	Whether intervention is clear and perceived as helpful on a scale of 1-5 (higher score indicates better perception of helpfulness)	At baseline (following the intervention), and at 1 and 3 months follow-ups
Utilization of the C-SPI	Whether the C-SPI was used or not (0 or 1)	Daily for a month (through EMA), and at 1 and 3 month follow-ups
Suicidal behavior	Whether suicidal behavior was present and how many times (count variable beginning with zero; higher score indicating worse outcome)	1 and 3 months
Suicidal ideation severity	On a scale of 0-5 with higher score indicating worse outcome	1 and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health treatment engagement/service utilization	Number of contact with mental health providers (count variable beginning with zero; higher score indicating better outcome)	1 and 3 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Children's Hospital of Philadelphia; American Foundation for Suicide Prevention

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Behavior; Suicidal Ideation
• Other Study ID Numbers: AAAV3403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No