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A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum

Primary Purpose

Suicidal Ideation, Suicidal and Self-injurious Behavior, Suicide

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Safety Planning Intervention tailored for Autistic Individuals

Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicide Prevention, Autism Spectrum Disorder, Safety Planning Intervention

Eligibility Criteria

12 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Participants

Inclusion Criteria:

15-24 years old
Able and willing to provide informed consent (age ≥18) or assent and parental consent (age <18)
Able to speak English
Have received a safety plan tailored for autistic youth during a clinical visit

Exclusion Criteria:

Altered mental status that precludes ability to provide informed assent or consent (acute psychosis, intoxication, or mania)

Clinician Participants

Inclusion Criteria:

Employment as a provider serving autistic patients at one of the study sites
Employment in a role that involves suicide risk intervention with youth patients at a participating clinic
Able to read and speak English
Able and willing to provide informed consent
18-99 years old

Exclusion Criteria:

There are no exclusion criteria for the clinician participants

Health System Leader Participants

Inclusion Criteria:

Health system or clinic leader at one of the study sites
Employed in a role that provides administrative oversight to clinicians conducting safety plans with patients
Able to read and speak English
Able and willing to provide informed consent
18-99 years old

Exclusion Criteria:

There are no exclusion criteria for the health system leader participants

Sites / Locations

Kennedy Krieger InstituteRecruiting
University of North Carolina at Chapel HillRecruiting
Nationwide Children's HospitalRecruiting
Children's Hospital of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Safety Planning Intervention Tailored for Autistic Individuals

Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts

Arm Description

The Safety Planning Intervention Tailored for Autistic individuals (SPI-A) is a brief collaborative intervention that results in an individually tailored plan designed to lower the short-term risk of suicide in autistic youth.

The Safety Planning Intervention Tailored for Autistic individuals plus structured follow-up contacts (SPI-A+) is a multi-component intervention comprised of SPI-A and structured follow-up consisting of at least 2 brief contacts.

Outcomes

Primary Outcome Measures

Change in suicidal ideation and behavior

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinical interview that measures suicidal ideation (range 0-5, with higher scores indicating more severe ideation) and suicidal behavior (count of total number of actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behavior). The C-SSRS will be administered at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.

Secondary Outcome Measures

Change in mental health treatment utilization

The Service Assessment for Children and Adolescents (SACA) is an interview designed to gather information on the patient participants' use of mental health services, including residential (e.g., hospital), outpatient (e.g., outpatient mental health clinic), and school (e.g., counseling) services. The SACA will be administered at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.

Change in quality of life

The Patient-Reported Outcomes Measurement Information System (PROMIS) Autism Battery - Lifespan (PAB-L) is a subset of PROMIS measures that has been validated for assessment of quality of life among autistic individuals. The PAB-L youth self-report includes four domains: Subjective Well-being, Relationships, Emotional Distress, and Health. Items are rated on a 1-5 scale, with higher scores indicating a greater presence of the measured construct. Patient participants will complete the PAB-L at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.

Change in well-being

Well-being will be measured with the Outcome Rating Scale (ORS), a 4-item visual analog scale assessing functioning in individual, interpersonal, social, and overall functioning over the past week. Item scores range from 0-10, with higher scores indicating better functioning. Patient participants will complete the ORS at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.

Change in skills to manage suicidal ideation

The Suicide-Related Coping Scale (SRCS) assesses knowledge of and confidence in using coping strategies and supports to manage suicidal thoughts and urges. The SRCS items are rated on a 5-point scale ("strongly disagree" to "strongly agree"). Higher scores indicate greater coping skills to manage suicidal crises. Patient participants will complete the SRCS at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.

Change in access to lethal means

The patient participants will answer the three access to lethal means questions from the Adapted Behavioral Risk Factor Surveillance System Survey (BRFSS), selected from the PhenX Toolkit, at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up. These questions capture whether firearms are present in the home and, if so, how they are stored (e.g., loaded and unlocked).

Change in safety plan use

The Brief Safety Plan Use Scale (BSPUS) will be used to assess the extent to which patient participants have utilized their safety plans since the prior assessment timepoint (e.g., "How many times did you use the safety plan since last meeting?" "Where have you been keeping the safety plan?"). Patient participants will complete the BSPUS at 1-month follow-up, 6-month follow-up, and 12-month follow-up.

Change in acute care services for suicidality

The Service Assessment for Children and Adolescents (SACA) will be used to assess patient participants' acute care services for suicidal thoughts and behaviors. The SACA will be administered at baseline, 1-month follow-up, 6-month follow-up, and 12-month follow-up.

Intervention acceptability

Patient, clinician, and health system leader participants will complete the Acceptability of Intervention Measure (AIM), a widely used four-item measure that can be administered to a wide range of stakeholders to determine the extent to which they believe an intervention is acceptable. Items are rated from 1-5, with higher scores indicating greater acceptability. Patient participants will complete the AIM at the 1-month follow-up timepoint. Clinician and health system leader participants will complete the AIM in Year 1 and Year 4 of the study.

Intervention feasibility

Patient, clinician, and health system leader participants will complete the Feasibility of Intervention Measure (FIM), a widely used four-item measure that can be administered to a wide range of stakeholders to determine the extent to which they believe an intervention is feasible. Items are rated from 1-5, with higher scores indicating greater feasibility. Patient participants will complete the FIM at the 1-month follow-up timepoint. Clinician and health system leader participants will complete the FIM in Year 1 and Year 4 of the study.

Full Information

NCT ID

NCT05398250

First Posted

May 25, 2022

Last Updated

July 20, 2023

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Patient-Centered Outcomes Research Institute, University of Pennsylvania, Nationwide Children's Hospital, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Children's Hospital of Philadelphia

1. Study Identification

Unique Protocol Identification Number

NCT05398250

Brief Title

A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum

Official Title

A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 23, 2022 (Actual)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Rates of suicide have increased significantly over the past two decades, particularly among youth. Compared to the general population, autistic people are significantly more likely to think about suicide, attempt suicide, and die by suicide. Autistic individuals have identified suicide prevention as a top research priority; however, little is known about how to best help autistic youth at risk for suicide. The purpose of this study is to compare the effectiveness, feasibility, and acceptability of two suicide prevention strategies tailored for autistic individuals: the Safety Planning Intervention tailored for Autistic individuals (SPI-A) and SPI-A plus structured follow-up contacts (SPI-A+).

Detailed Description

This study includes three aims: Aim 1: Among autistic youth (age 12-24) at risk for suicide, compare the effectiveness of SPI-A vs. SPI-A+. The primary outcomes of interest are suicidal ideation (SI) and suicidal behavior (SB). Secondary patient-centered outcomes are mental health treatment initiation and engagement, quality of life, well-being, skills to manage SI, access to lethal means, safety plan use, and acute care services for suicidality. Aim 2: Compare implementation outcomes of acceptability and feasibility for the two interventions from the perspectives of patients, clinicians, and health system administrators. Aim 3: Explore patient characteristics that may moderate the relationship between intervention and SI and SB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suicidal Ideation, Suicidal and Self-injurious Behavior, Suicide, Autism Spectrum Disorder

Keywords

Suicide Prevention, Autism Spectrum Disorder, Safety Planning Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1665 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Safety Planning Intervention Tailored for Autistic Individuals

Arm Type

Active Comparator

Arm Description

Arm Title

Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Safety Planning Intervention tailored for Autistic Individuals

Other Intervention Name(s)

SPI-A

Intervention Description

To develop the SPI-A, clinicians work collaboratively with patients, and when indicated, their family members, to create a list of concrete coping mechanisms to be enacted leading up to or during a crisis. This list can be depicted in writing or pictorially, depending on patient preference. As part of the intervention, patients (and family members, when appropriate) also identify warning signs that signal the need to use the safety plan, as well as a detailed plan for reducing access to lethal means. SPI-A is a stand-alone intervention without a follow-up component.

Intervention Type

Behavioral

Intervention Name(s)

Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts

Other Intervention Name(s)

SPI-A+

Intervention Description

SPI-A+ includes SPI-A plus a structured follow-up component. The structured follow-up component of SPI-A+ includes three elements: A brief risk assessment and mood check Review and, if needed, revision of SPI-A Support related to outpatient mental health treatment initiation

Primary Outcome Measure Information:

Title

Change in suicidal ideation and behavior

Description

Time Frame

Through 12 months of follow-up

Secondary Outcome Measure Information:

Title

Change in mental health treatment utilization

Description

Time Frame

Up to 12 months

Title

Change in quality of life

Description

Time Frame

Up to 12 months

Title

Change in well-being

Description

Time Frame

Up to 12 months

Title

Change in skills to manage suicidal ideation

Description

Time Frame

Up to 12 months

Title

Change in access to lethal means

Description

Time Frame

Up to 12 months

Title

Change in safety plan use

Description

Time Frame

Up to 12 months

Title

Change in acute care services for suicidality

Description

Time Frame

Up to 12 months

Title

Intervention acceptability

Description

Time Frame

Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years

Title

Intervention feasibility

Description

Time Frame

Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Patient Participants Inclusion Criteria: 12-24 years old Able and willing to provide informed consent (age ≥18) or assent and parental consent (age <18) Able to speak English Have received a safety plan tailored for autistic youth during a clinical visit Exclusion Criteria: Altered mental status that precludes ability to provide informed assent or consent (acute psychosis, intoxication, or mania) Clinician Participants Inclusion Criteria: Employment as a provider serving autistic patients at one of the study sites Employment in a role that involves suicide risk intervention with youth patients at a participating clinic Able to read and speak English Able and willing to provide informed consent 18-99 years old Exclusion Criteria: There are no exclusion criteria for the clinician participants Health System Leader Participants Inclusion Criteria: Health system or clinic leader at one of the study sites Employed in a role that provides administrative oversight to clinicians conducting safety plans with patients Able to read and speak English Able and willing to provide informed consent 18-99 years old Exclusion Criteria: There are no exclusion criteria for the health system leader participants

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brenna Maddox, PhD

Phone

919.966.0258

brenna_maddox@med.unc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brenna Maddox, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shari Jager-Hyman, PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kennedy Krieger Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21113

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Lipkin, MD

Phone

443-923-3240

Lipkin@KennedyKrieger.org

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27510

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brenna Maddox, PhD

Phone

919-966-0258

brenna_maddox@med.unc.edu

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric Butter, PhD

Phone

614-722-4700

eric.butter@nationwidechildrens.org

Facility Name

Children's Hospital of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amanda Bennett, MD

Phone

267-426-7540

bennettam@chop.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified individual data that support the results will be shared after the publication of the final research report, for a period of at least 7 years, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

Deidentified individual data that support the results will be shared after the publication of the final research report, for a period of at least 7 years.

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Learn more about this trial

A Comparison of Two Brief Suicide Prevention Interventions Tailored for Youth on the Autism Spectrum

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