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Enrolling by invitationNCT07564583Updated Nov 6, 2026

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

An interventional study of Child - Safety Planning Intervention and C-SPI+ecological momentary assessment in Suicidal Ideation and Suicidal Behaviors, sponsored by Columbia University. Enrolling by invitation at 1 site in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Columbia University · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

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.
02

Conditions studied

  • Suicidal Ideation
  • Suicidal Behaviors

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03

In context

Suicidal Ideation

569 studies on the registry are indexed under Suicidal Ideation; 203 are open to participants now.

This study's planned enrollment of 90 is above the median of 80 across 469 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.

Browse Columbia University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Child received a diagnosis of a psychotic disorder or intellectual disability
  • Child is suffering from active mania
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • No intervention
    Treatment as usual (TAU)
  • Experimental
    Child-safety planning intervention (C-SPI) + TAU

    Child - Safety Planning Intervention

    Behavioral: Child - Safety Planning Intervention

  • Other
    C-SPI + TAU + ecological momentary assessment

    Child - Safety Planning Intervention and daily reporting

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

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.

    Also known as: C-SPI

  • BehavioralC-SPI+ecological momentary assessment

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

    Also known as: EMA, C-SPI

06

What researchers measure

Primary outcomes

  1. 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)

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

  2. Utilization of the C-SPI

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

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

  3. Suicidal behavior

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

    Time frame: 1 and 3 months

  4. Suicidal ideation severity

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

    Time frame: 1 and 3 months

Secondary outcomes

  1. Mental health treatment engagement/service utilization

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

    Time frame: 1 and 3 months

07

Study locations

1 site
  • Children Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for May 2027, 8 months after the start.

Of 281 non-industry interventional studies with no phase under Suicidal Ideation, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 8 months is below that.

Counting every sponsor, half of 290 studies reached it within 29 months; a quarter within 13 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2026
First posted
May 4, 2026
StartActual
Sep 30, 2026
Primary completionEst.
May 31, 2027
CompletionEst.
May 31, 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 9, 2026→Sep 30, 2026 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Start date Sep 9, 2026→Sep 30, 2026 (now actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07564583
Lead sponsor
Columbia University
Collaborators
Children's Hospital of Philadelphia, American Foundation for Suicide Prevention
Responsible party
Liat Itzhaky (Adjunct Associate Research Scientist in the Department of Psychiatry, Columbia University) — Principal investigator
First posted
May 4, 2026
Start date
Sep 30, 2026
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Liat Itzhaky, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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