Suicidal IdeationNCT07564583
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
A study testing Child - Safety Planning Intervention and C-SPI+ecological momentary assessment in people with Suicidal Ideation and Suicidal Behaviors, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Suicidal Ideation, Suicidal Behaviors
- What is being tested?
- Child - Safety Planning Intervention and C-SPI+ecological momentary assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Child received a diagnosis of a psychotic disorder or intellectual disability
- Child is suffering from active mania
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this 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:
Read more
- Does the intervention appear clear and acceptable to the children and caregivers?
- 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:
- Children and parents will respond to questions in an interview and through self-reports in an in-person meeting
- Children and parents will receive the intervention (those in the intervention groups)
- Parents will report daily for one month (only those in the intervention + reporting group)
- 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
- Being tested
- Child - Safety Planning Intervention, C-SPI+ecological momentary assessment
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child - Safety Planning InterventionBehavioural
Also called C-SPI
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.
C-SPI+ecological momentary assessmentBehavioural
Also called EMA, C-SPI
C-SPI and daily, self-reported use of C-SPI
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | No intervention | Not described |
| Child-safety planning intervention (C-SPI) + TAU | Experimental | Child - Safety Planning Intervention Receives: Behavioral: Child - Safety Planning Intervention |
| C-SPI + TAU + ecological momentary assessment | Other | Child - Safety Planning Intervention and daily reporting Receives: Behavioral: Child - Safety Planning Intervention; Behavioral: C-SPI+ecological momentary assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 1 and 3 months
Suicidal ideation severity
On a scale of 0-5 with higher score indicating worse outcome
Measured: 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)
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start9 Sep 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Liat Itzhaky, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564583
- Sponsor's protocol ID
- AAAV3403
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
- ClinicalTrials.gov ID
- NCT07564583
- Acronym / sponsor ID
- AAAV3403
- Conditions
- Suicidal Ideation, Suicidal Behaviors
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, American Foundation for Suicide Prevention
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the intervention appear clear and acceptable to the children and caregivers?
- 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:
- Children and parents will respond to questions in an interview and through self-reports in an in-person meeting
- Children and parents will receive the intervention (those in the intervention groups)
- Parents will report daily for one month (only those in the intervention + reporting group)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | No intervention | – |
| Child-safety planning intervention (C-SPI) + TAU | Experimental | Behavioral: Child - Safety Planning InterventionChild - Safety Planning Intervention |
| C-SPI + TAU + ecological momentary assessment | Other | Behavioral: Child - Safety Planning Intervention, Behavioral: C-SPI+ecological momentary assessmentChild - Safety Planning Intervention and daily reporting |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Child received a diagnosis of a psychotic disorder or intellectual disability
- Child is suffering from active mania
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child - Safety Planning InterventionAlso: C-SPIThe 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. | Behavioural | C-SPI + TAU + ecological momentary assessment, Child-safety planning intervention (C-SPI) + TAU |
| C-SPI+ecological momentary assessmentAlso: EMA, C-SPIC-SPI and daily, self-reported use of C-SPI | Behavioural | C-SPI + TAU + ecological momentary assessment |
Primary outcome
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)
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)
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)
Suicidal ideation severity
Time frame: 1 and 3 months
On a scale of 0-5 with higher score indicating worse outcome
1 secondary outcome
Mental health treatment engagement/service utilization
Time frame: 1 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child - Safety Planning Intervention and C-SPI+ecological momentary assessment in people with Suicidal Ideation and Suicidal Behaviors, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the C-SPI (time frame: At baseline (following the intervention), and at 1 and 3 months follow-ups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.