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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NCAutism+4 MoreSafety Planning Intervention tailored for Autistic Individuals - Behavioral
Eligibility
15 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two suicide prevention strategies to see which is more effective, feasible, and acceptable for autistic individuals.

Eligible Conditions
  • Autism
  • Suicidal and Self-Harm Behaviour
  • Suicidal Thoughts
  • Suicide

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Patient Participants: 1-month follow-up; Clinician and Health System Leader Participants: up to 4 years

Year 4
Intervention acceptability
Intervention feasibility
Month 12
Feeling suicidal (finding)
Up to 12 months
Change in access to lethal means
Change in acute care services for suicidality
Therapeutic procedure
Change in quality of life
Change in safety plan use
Change in skills to manage suicidal ideation
Change in well-being

Trial Safety

Trial Design

2 Treatment Groups

Safety Planning Intervention Tailored for Autistic Individuals Plus Structured F...
1 of 2
Safety Planning Intervention Tailored for Autistic Individuals
1 of 2

Active Control

1665 Total Participants · 2 Treatment Groups

Primary Treatment: Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts · No Placebo Group · N/A

Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts
Behavioral
ActiveComparator Group · 1 Intervention: Safety Planning Intervention Tailored for Autistic Individuals Plus Structured Follow-Up Contacts · Intervention Types: Behavioral
Safety Planning Intervention Tailored for Autistic Individuals
Behavioral
ActiveComparator Group · 1 Intervention: Safety Planning Intervention tailored for Autistic Individuals · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: patient participants: 1-month follow-up; clinician and health system leader participants: up to 4 years

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
497 Previous Clinical Trials
29,834,611 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
661 Previous Clinical Trials
7,853,821 Total Patients Enrolled
University of PennsylvaniaOTHER
1,875 Previous Clinical Trials
41,147,054 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,385 Previous Clinical Trials
3,939,615 Total Patients Enrolled
Nationwide Children's HospitalOTHER
313 Previous Clinical Trials
5,214,157 Total Patients Enrolled
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.OTHER
82 Previous Clinical Trials
22,823 Total Patients Enrolled
Brenna Maddox, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Shari Jager-Hyman, PhDPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
25 Total Patients Enrolled

Eligibility Criteria

Age 15 - 99 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
I'm sorry, but it seems like the criterion you provided is incomplete. Can you please provide more information?
You are between the ages of 15 and 24.
You have received a safety plan designed for youth with autism during a previous clinical visit.
You understand the study and agree to participate if you are 18 years or older. If you are under 18 years old, you and your parent or guardian must agree to participate.
You can speak and understand English.

Who else is applying?

What state do they live in?
Michigan100.0%
What site did they apply to?
Nationwide Children's Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Does this research accommodate individuals over 30 years of age?

"The eligibility requirements for this medical trial specify that participants must be between 15 and 99 years old. Meanwhile, there are 309 trials intended specifically for minors aged under 18, with 197 more catered to seniors over 65." - Anonymous Online Contributor

Unverified Answer

What is the current geographic scope of this investigative endeavor?

"Four medical institutions are collaborating on this research including Nationwide Children's Hospital in Columbus, Kennedy Krieger Institute in Baltimore, and Children's Hospital of Pennsylvania in Philadelphia. Additionally, there are 4 additional sites engaged with the project." - Anonymous Online Contributor

Unverified Answer

What criteria must one meet in order to be enrolled in this clinical trial?

"This trial, which seeks to recruit 1665 participants, offers the potential of participation for those with suicidal tendencies aged 15-99." - Anonymous Online Contributor

Unverified Answer

Are there vacancies open to participants in this clinical investigation?

"Yes, according to clinicaltrials.gov this medical trial is still recruiting participants. It was initially posted on August 23rd 2022 and the last edit occurred October 11th of that same year." - Anonymous Online Contributor

Unverified Answer

To what extent has patient participation been observed in this clinical research?

"Verified. Clinicaltrials.gov reveals that enrollment for this clinical trial is currently open. It was initially posted on August 23rd 2022 and has since been updated most recently on October 11th of the same year. 1665 participants must be sourced from 4 distinct sites in order to reach completion goals." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.