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

NCT07564583 | Enrolling By Invitation DMC

• 1 other identifier: AAAV3403
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 1.Does the intervention appear clear and acceptable to the children and caregivers?
2. 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.
3. 3.Children and parents will respond to questions in an interview and through self-reports in an in-person meeting
4. 4.Children and parents will receive the intervention (those in the intervention groups)
5. 5.Parents will report daily for one month (only those in the intervention + reporting group)
6. 6.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.

Conditions

Suicidal Ideation; Suicidal Behaviors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Mental health treatment engagement/service utilization

  1 and 3 months

Study Arms (3)

Treatment as usual (TAU)

NO INTERVENTION

Child-safety planning intervention (C-SPI) + TAU

EXPERIMENTAL

Child - Safety Planning Intervention

Behavioral: Child - Safety Planning Intervention

C-SPI + TAU + ecological momentary assessment

OTHER

Child - Safety Planning Intervention and daily reporting

Behavioral: Child - Safety Planning Intervention; Behavioral: C-SPI+ecological momentary assessment

Interventions

Child - Safety Planning Intervention BEHAVIORAL

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.

Also known as: C-SPI

C-SPI + TAU + ecological momentary assessment; Child-safety planning intervention (C-SPI) + TAU

C-SPI+ecological momentary assessment BEHAVIORAL

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

Also known as: EMA, C-SPI

C-SPI + TAU + ecological momentary assessment

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Child received a diagnosis of a psychotic disorder or intellectual disability
• Child is suffering from active mania

Sponsors & Collaborators

• Columbia University: lead
• American Foundation for Suicide Prevention: collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Children Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)