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Crisis Interventions for Pediatric Providers - Autism Version

ConditionsAutismSuicide Prevention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChildren's Hospital Los Angeles

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Safety Planning InterventionActive comparator 1 intervention
Group B: Crisis Interventions for Pediatric Providers - Autism version (CIPP-A)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Baseline to 6 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Los Angeles

Lead sponsor

Children's Hospital of Philadelphia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: