A Pilot Participatory Program Evaluation of a Virtual Trauma Support Program for Autistic Adults

Efficacy of a Posttraumatic Stress Disorder (PTSD) Intervention for Autistic Adults on Biobehavioral Health

The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are:

• Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET?
• Do biobehavioral health outcomes, including objective (Fitbit indicators of activity, sleep, and heart rate) and subjectively-reported health variables (e.g., sleep, pain, health-related quality of life), improve after receiving WET?
• How do autistic adults experience WET, and how can this program be modified and enhance in the future in collaboration with autistic adults?

Participants will complete the following as part of the study, which is completed entirely over telehealth.

• Participants will first complete an initial assessment, involving brief measures of cognition and autistic traits, as well as interviews and questionnaires about PTSD, mental health, and physical health. If eligible, participants will proceed to the following steps:
• Eligible participants will then start wearing a Fitbit, to be used for the duration of the study.
• Participants will then participate in 5 weekly virtual visits involving the WET protocol, including weekly brief assessment of PTSD and mental and physical health.
• Then, participants will complete a sixth virtual visit the following week where PTSD, mental and physical health, and treatment feedback are assessed.
• Lastly, participants will complete virtual visits 1 and 6 months later involving re-assessment of PTSD and mental and physical health.

Therefore, this is a pre-post single group design, where all participants will receive WET to establish initial efficacy and feasibility. Investigators will also consult with an autistic advisory board throughout the project, and make adaptations as recommended in consultation with autistic adults. The goal is to better understand the initial efficacy and feasibility of WET for supporting autistic adults who have experienced trauma.

Study Overview

• Status: Completed
• Conditions: Trauma; Posttraumatic Stress Disorder; Autism; Posttraumatic Stress Symptom
• Intervention / Treatment: Behavioral: Written Exposure Therapy (WET) via telehealth

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wyoming
    • Laramie, Wyoming, United States, 82071
      • University of Wyoming

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Autistic
• Age 18 years or over
• Has experienced trauma and reports clinically significant symptoms of traumatic stress (clinically elevated score on either Posttraumatic Symptom Checklist (PCL-5) or Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5), and/or other self-report/interview evidence of significant traumatic stress symptoms for which participant wants support/program
• Comfortable speaking and writing in English
• Full Scale Intelligence Quotient (FSIQ) score >= 65 (given written nature of Written Exposure Therapy) on the Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
• Access to device with internet access for telehealth visits

Exclusion Criteria:

• Participant is not Autistic
• Participant is unable to understand English
• Participant is currently receiving trauma-focused therapeutic services
• Participant does not have access to internet connected device for telehealth visits
• Participant receives Full Scale Intelligence Quotient (FSIQ) score < 65 on the Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
• If there are significant safety concerns for any participant (e.g., imminent risk of harm to self or other) the Principal Investigator may determine whether it is not in the adult's best interest to be enrolled given that this study does not provide care/services relating to active risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Written Exposure Therapy; Behavioral therapy: Written Exposure Therapy via telehealth	Behavioral: Written Exposure Therapy (WET) via telehealth; Written Exposure Therapy (WET) via telehealth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale	The Posttraumatic Symptom Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 is a self-report questionnaire of posttraumatic stress disorder symptoms. Total scores range from 0-80; higher scores indicate higher levels of posttraumatic stress disorder symptoms.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale	The PHQ is a self-report measure of depressive symptoms. Total scores range from 0-27; higher scores reflect greater levels of depressive symptoms.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Anxiety Symptoms on the Anxiety Scale for Autism-Adults (ASA-A)	The Anxiety Scale for Autism-Adults (ASA-A) is a self-report measure for anxiety symptoms among autistic adults. Total scores range from 0 to 60; higher scores reflect higher anxiety symptoms.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Loneliness Symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale	The University of California Los Angeles (UCLA) 3-Item Loneliness Scale is a self-report measure for symptoms of loneliness. Scores range from 3 to 9; higher scores reflect higher levels of loneliness.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Psychological Adjustment Concerns on the Brief Adjustment Scale (BASE-6)	The Brief Adjustment Scale (BASE-6) is a brief self-report symptom monitoring measure for general psychological adjustment. Scores from from 6 to 42; higher scores reflect greater psychological adjustment concerns.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Experiential Avoidance Symptoms on the Brief Experiential Avoidance Questionnaire	The Brief Experiential Avoidance Questionnaire is a self-report measure of experiential avoidance. Scores range from 15 to 90; higher scores reflect greater levels of experiential avoidance.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Emotion Regulation Difficulties on the Difficulties in Emotion Regulation Scale (DERS-16)	The Difficulties in Emotion Regulation Scale (DERS-16) is a self-report measure of emotion regulation difficulties. Scores range from 16 to 80; higher scores reflect greater emotion regulation difficulties.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Stigma Towards Help-seeking on the Ultra-Brief Self-Stigma of Seeking Help (SSOSH-3) Scale	The Ultra Brief Self-Stigma of Seeking Help (SSOSH-3) Scale is a self-report measure of stigma towards seeking psychological support. Scores range from 3 to 15; higher scores reflect greater stigma.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)	The Camouflaging Autistic Traits Questionnaire (CATQ) is a self-report measure of masking autistic traits. Scores range from 25 to 175; greater scores reflect a higher level of camouflaging.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Sleep Difficulties on the Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep difficulties. Scores range from 0 to 21; higher scores reflect greater sleep difficulties.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Pain Intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.	The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale is a self-report measure of pain intensity. Total scores range from 3 to 15; higher scores reflect more intense pain.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Pain Interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.	The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale is a self-report measure of pain interference. Total scores range from 8 to 40; higher scores reflect a greater level of pain interference.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Physical Activity as Assessed on Fitbit.	Participants Fitbit measurements of number of steps (average past week daily steps) will be assessed via their Fitbit device.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Sleep Duration as Assessed on Fitbit.	Participants Fitbit measurements of sleep duration in hours (past weekly nightly average in hours) will be assessed via their Fitbit device. A higher sleep duration indicates greater numbers slept.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Resting Heart Rate as Assessed on Fitbit.	Participants Fitbit measurements of resting heart rate (past week daily average) will be assessed via their Fitbit device.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Autistic Quality of Life on the Autism Spectrum Quality of Life Scale.	The Autism Spectrum Quality of Life Scale is a self-report measure of quality of life relating to autism. Total scores range from 9 to 45, and higher scores reflect greater quality of life.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Overall Quality of Life on the World Health Organization Quality of Life Scale	The World Health Organization Quality of Life Scale (WHO QOL) is a 26-item self-report questionnaire of quality of life. Summed total scores range from 26 to 130, and higher scores reflect greater quality of life.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
Change in Positive Autistic Identity on the Autism Spectrum Identity Scale (ASIS)	The Autism Spectrum Identity Scale (ASIS) is a 22-item self-report of autistic identity. Total scores range from 22 to 110, and higher scores reflect a more positive Autistic identity.	Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)

Collaborators and Investigators

• Sponsor: University of Wyoming

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): February 12, 2025

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Autism Spectrum Disorder; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Stress Disorders, Traumatic; Wounds and Injuries; Autistic Disorder; Stress Disorders, Post-Traumatic; Chemical Phenomena; Hydrophobic and Hydrophilic Interactions; Surface Properties; Wettability
• Other Study ID Numbers: 20230331CM03524

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No