Crisis Interventions for Pediatric Providers - Autism Version

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?

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 Overview

• Status: Not yet recruiting
• Conditions: Autism; Suicide Prevention
• Intervention / Treatment: Behavioral: Safety Planning Intervention; Behavioral: Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica M Schwartzman, PhD; Phone Number: 323-207-5910; Email: trendlab@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
      • Contact: Jessica Schwartzman, PhD; Phone Number: 323-207-5910; Email: trendlab@chla.usc.edu
      • Principal Investigator: Jessica Schwartzman, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Safety Planning Intervention; The SPI is a brief, evidence-based suicide prevention intervention for youth and adults that can be delivered by diverse providers.	Behavioral: Safety Planning Intervention; 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	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.	6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Jessica Schwartzman, PhD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Autism; Safety Planning Intervention; Suicide Prevention; Pediatric Clinics
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Mental Disorders; Behavioral Symptoms; Self-Injurious Behavior; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Suicide; Behavior; Suicide Prevention; Autistic Disorder; Psychotherapy; Behavioral Disciplines and Activities; Crisis Intervention
• Other Study ID Numbers: CHLA-25-00359; 6UM4MC54988-01-03 (Other Grant/Funding Number: Health Resources and Services Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No