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NCT Number: NCT07508436

Crisis Interventions for Pediatric Providers - Autism Version

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location contact

Jessica Schwartzman, PhD

CONTACT

[email protected]

323-207-5910

Jessica Schwartzman, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Safety Planning Intervention

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Feasibility of Intervention Measure

    Time frame: Baseline to 6 months

    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.

  2. Fidelity of implementation

    Time frame: 6 months

    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.

  3. Semi-structured interview to assess intervention feasibility

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica M Schwartzman, PhD

CONTACT

[email protected]

323-207-5910

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 2, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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