NCT07508436

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Dec 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

March 27, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

AutismSuicide PreventionSafety Planning InterventionPediatric Clinics

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Feasibility of Intervention Measure

    Baseline to 6 months

  • Fidelity of implementation

    6 months

  • Semi-structured interview to assess intervention feasibility

    6 months

Study Arms (2)

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.

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.

Behavioral: Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)

Interventions

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.

Safety Planning Intervention

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Autistic DisorderSuicide Prevention

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jessica Schwartzman, PhD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica M Schwartzman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Staff/USC Faculty CWR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 2, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations