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AutismNCT07508436

Crisis Interventions for Pediatric Providers - Autism Version

A study testing Safety Planning Intervention and Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) in people with Autism and Suicide Prevention, run by Children's Hospital Los Angeles at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to examine the initial feasibility, acceptability, and effectiveness of Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) for providers serving autistic youth in outpatient settings. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Autism, Suicide Prevention
What is being tested?
Safety Planning Intervention and Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to 31 Dec 2028
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Pediatric healthcare providers serving autistic youth in a DBP clinic in the U.S.
  • Willing and able to participate in the study and its activities, including remote training in either SPI or CIPP-A (depending on randomization)
  • Willing and able to provide informed consent
  • Comfortable speaking or communicating in English

Who cannot join

  • Pediatric healthcare providers not serving autistic youth
  • Pediatric healthcare providers not practicing in a DBP clinic in the U.S.
  • Unwilling and unable to participate in the study and its activities
  • Unwilling and unable to provide informed consent
  • Not comfortable speaking or communicating in English

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica M Schwartzman, PhD contact

323-207-5910

trendlab@chla.usc.edu

United States1 site
  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Jessica Schwartzman, PhD, 323-207-5910, trendlab@chla.usc.edu

    Jessica Schwartzman, PhD

Other trials in United States

About this study

Official title: Safety Planning for Autistic Youth: A Randomized Controlled Trial With Providers in Pediatric Clinics

The goal of this clinical trial is to examine the initial feasibility, acceptability, and effectiveness of Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) for providers serving autistic youth in outpatient settings. The main question aims to answer:

  • Assess whether CIPP-A is feasible and acceptable to providers in development behavioral pediatric clinics?
  • Assess whether CIPP-A shows initial effectiveness in increasing providers confidence in managing suicide risk in autistic youth?
Read more

If there is a comparison group: Researchers will compare CIPP-A to general safety planning intervention (SPI) on feasibility, acceptability, and initial effectiveness.

Participants will be randomized to receive training in SPI or CIPP-A and complete online surveys and interviews over 6-months to measure feasibility, acceptability, and initial effectiveness.

Being tested
Safety Planning Intervention, Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)
Keywords
Autism, Suicide Prevention, Safety Planning Intervention, Pediatric Clinics
Medical subject headings
Autistic Disorder, Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Safety Planning InterventionBehavioural

    The Safety Planning Intervention (SPI) is leading, evidence-based intervention that manages risks associated with suicidal thoughts and behaviors in youth. The SPI is delivered by providers to youth and their parents/guardians and focuses on teaching the family a series of safety planning steps to keep youth safe as they experience suicidal thoughts and/or behaviors. The SPI can be delivered by providers to families in person or virtually during clinic visits, and shows effectiveness in increasing child safety. Further, the SPI is a flexible intervention that can be delivered by a variety of healthcare professionals (e.g., pediatricians, social workers, nurses, etc.). The SPI has been found to be effective when delivered in emergency, inpatient, and outpatient settings; in this study, the SPI will be delivered by providers in Developmental-Behavioral Pediatric (DBP) settings.

  • Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)Behavioural

    The CIPP-A is an autism-specific crisis intervention for pediatric providers co-developed by the PI (licensed psychologist) and autistic people, which was published in Pediatrics. Similar to the SPI, CIPP-A is delivered by providers to youth and their parents and focuses on teaching the family a series of crisis interventions to keep youth safe as they experience suicidal thoughts and/or behaviors, with autism-specific adaptations. Autism-specific adaptations include warning signs (e.g., sensory overload, social burnout) that may be unique to this population, as well as coping skills (e.g., quiet time alone in sensory friendly environment, engagement in preferred interests). The CIPP-A contains an overview of autism and how suicidal thoughts/behaviors may present differently in this population. The CIPP-A can be delivered by providers to families in person or virtually during clinic visits. Further, the CIPP-A is can be flexibly delivered by a variety of healthcare professionals.

Study groups in NCT07508436
Study groupRoleWhat they receive
Safety Planning InterventionActive comparatorThe SPI is a brief, evidence-based suicide prevention intervention for youth and adults that can be delivered by diverse providers.
Receives: Behavioral: Safety Planning Intervention
Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)ExperimentalThe CIPP-A is a brief suicide prevention intervention for youth and adults that can be delivered by diverse providers and has been adapted for autistic youth.
Receives: Behavioral: Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility: Number of times that providers use SPI or CIPP-A in 6 months

    The feasibility of SPI and CIPP-A will be assessed by an online survey of the number of times that providers used SPI/CIPP-A with autistic patients in 6 months. Higher scores indicate greater feasibility and use of SPI/CIPP-A (i.e., better outcome).The survey will be administered three times from baseline to 6 months.

    Measured: Baseline to 6 months

  2. Acceptability: Acceptability of Intervention Measure

    The Acceptability of Intervention Measure (AIM) will be administered to providers to assess perceived acceptability of SPI and CIPP-A. The AIM is a widely used measure of the extent to which stakeholders believe an intervention is satisfactory in a given setting (e.g., "I like SPI"). The AIM items are scored on a 5-point scale (1, completely disagree to 5, completely agree), with total scores ranging from 5-25. Higher scores indicate greater acceptability (i.e., better outcome). The AIM will be administered three times from baseline to 6 months.

    Measured: Baseline to 6 months

  3. Initial Effectiveness: Providers confidence in using SPI or CIPP-A

    A series of visual analog scales (VAS; 0-100%) will be used to measure changes in providers' confidence in managing patient crises over the study, with total scores ranging from 0-100. Higher scores indicate greater effectiveness (i.e., better outcome). The VAS will be administered three times from baseline to 6 months.

    Measured: Baseline to 6 months

Secondary outcomes (3)
  1. Feasibility of Intervention Measure

    A secondary outcome measure of the feasibility of SPI and CIPP-A will be assessed by the Feasibility of Intervention Measure (FIM), which assesses the extent to which stakeholders believe an intervention can be delivered in a given setting (e.g., "SPI seems easy to use"). The FIM items are scored on a 5-point scale (1, completely disagree to 5, completely agree), with total scores ranging from 5-25. Higher scores indicate greater feasibility (i.e., better outcome). The FIM will be administered three times from baseline to 6 months.

    Measured: Baseline to 6 months

  2. Fidelity of implementation

    A secondary outcome measure of the feasibility of SPI and CIPP-A will be assessed by a fidelity of implementation survey from providers about their adherence to SPI/CIPP-A components on the Fidelity Survey. Fidelity scores may range from 0-20 with higher scores indicating higher fidelity. The fidelity survey will be administered two times over 6 months.

    Measured: 6 months

  3. Semi-structured interview to assess intervention feasibility

    A secondary outcome measure of the feasibility of SPI and CIPP-A will be assessed by a semi-structured interview to better understand providers' feasibility experiences (30-40 min). The interview will be administered once at 6 months.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Model description
Pediatric providers will be randomized 1:1 to receive training in Safety Planning Intervention (SPI; control condition) or Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508436
Sponsor's protocol ID
CHLA-25-00359
Other IDs
6UM4MC54988-01-03
Status last verified
Apr 2026
First submitted
27 Mar 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Safety Planning Intervention and Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) in people with Autism and Suicide Prevention, run by Children's Hospital Los Angeles 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 5 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: opening soon, as of the sponsor's last update on 13 Apr 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?

Contact Jessica M Schwartzman, PhD (323-207-5910, trendlab@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Number of times that providers use SPI or CIPP-A in 6 months (time frame: Baseline to 6 months). The study lists 3 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 13 Apr 2026.

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