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Enrolling by Invitation

NCT Number: NCT07564583

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: C-SPI

C-SPI+ecological momentary assessment

Behavioral

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

Other names: EMA, C-SPI

Primary outcomes

  1. Feasibility and acceptability of the C-SPI

    Time frame: At baseline (following the intervention), and at 1 and 3 months follow-ups

    Whether intervention is clear and perceived as helpful on a scale of 1-5 (higher score indicates better perception of helpfulness)

  2. Utilization of the C-SPI

    Time frame: Daily for a month (through EMA), and at 1 and 3 month follow-ups

    Whether the C-SPI was used or not (0 or 1)

  3. Suicidal behavior

    Time frame: 1 and 3 months

    Whether suicidal behavior was present and how many times (count variable beginning with zero; higher score indicating worse outcome)

  4. Suicidal ideation severity

    Time frame: 1 and 3 months

    On a scale of 0-5 with higher score indicating worse outcome

Secondary outcomes

  1. Mental health treatment engagement/service utilization

    Time frame: 1 and 3 months

    Number of contact with mental health providers (count variable beginning with zero; higher score indicating better outcome)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • American Foundation for Suicide Prevention
  • Children's Hospital of Philadelphia

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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