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

NCT07564583 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

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

BEHAVIORAL

C-SPI+ecological momentary assessment

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07564583 on ClinicalTrials.gov