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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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.
- Conditions
- Autism, Suicide Prevention
- 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 group | Role | What they receive |
|---|---|---|
| Safety Planning Intervention | Active comparator | The 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) | Experimental | The 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.
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
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
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)
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
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
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.
- First posted2 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Jessica Schwartzman, Children's Hospital Los Angeles
- Investigators
- Jessica Schwartzman, PhD, Principal investigator, Children's Hospital Los Angeles
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Planning for Autistic Youth: A Randomized Controlled Trial With Providers in Pediatric Clinics
- ClinicalTrials.gov ID
- NCT07508436
- Acronym / sponsor ID
- CHLA-25-00359
- Conditions
- Autism, Suicide Prevention
- Keywords
- Autism, Suicide Prevention, Safety Planning Intervention, Pediatric Clinics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Apr 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 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?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Safety Planning Intervention | Active comparator | Behavioral: Safety Planning InterventionThe SPI is a brief, evidence-based suicide prevention intervention for youth and adults that can be delivered by diverse providers. |
| Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) | Experimental | Behavioral: Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Safety Planning InterventionThe 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. | Behavioural | Safety Planning Intervention |
| Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)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. | Behavioural | Crisis Interventions for Pediatric Providers - Autism version (CIPP-A) |
Primary outcome
Feasibility: Number of times that providers use SPI or CIPP-A in 6 months
Time frame: Baseline to 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.
Acceptability: Acceptability of Intervention Measure
Time frame: Baseline to 6 months
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.
Initial Effectiveness: Providers confidence in using SPI or CIPP-A
Time frame: Baseline to 6 months
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.
3 secondary outcomes
Feasibility of Intervention Measure
Time frame: Baseline to 6 months
Fidelity of implementation
Time frame: 6 months
Semi-structured interview to assess intervention feasibility
Time frame: 6 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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Jessica Schwartzman, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
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.