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

NCT05862467 | Completed

• 1 other identifier: 20230331CM03524
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; Trauma; Posttraumatic Stress Disorder; Posttraumatic Stress Symptom

Outcome Measures

Primary Outcomes (1)

• 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 (an average of 6 months)

Secondary Outcomes (17)

• Change in depressive symptoms on the Patient Health Questionnaire (PHQ) Scale

  Change across baseline to follow-up (an average of 6 months)

• Change in anxiety symptoms on the Anxiety Scale for Autism-Adults (ASA-A)

  Change across baseline to follow-up (an average of 6 months)

• Change in loneliness symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale

  Change across baseline to follow-up (an average of 6 months)

• Change in psychological adjustment concerns on the Brief Adjustment Scale (BASE-6)

  Change across baseline to follow-up (an average of 6 months)

• Change in experiential avoidance symptoms on the Brief Experiential Avoidance Questionnaire

  Change across baseline to follow-up (an average of 6 months)

Other Outcomes (10)

• Change in autistic quality of life on the Autism Spectrum Quality of Life Scale.

  Change across baseline to follow-up (an average of 6 months)

• Change in overall quality of life on the World Health Organization Quality of Life Scale

  Change across baseline to follow-up (an average of 6 months)

• Change in positive Autistic identity on the Autism Spectrum Identity Scale (ASIS)

  Change across baseline to follow-up (an average of 6 months)

Study Arms (1)

Written Exposure Therapy

EXPERIMENTAL

Behavioral therapy: Written Exposure Therapy via telehealth

Behavioral: Written Exposure Therapy (WET) via telehealth

Interventions

Written Exposure Therapy (WET) via telehealth BEHAVIORAL

Written Exposure Therapy (WET) via telehealth

Written Exposure Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wyoming: lead

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82071, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Wounds and Injuries; Stress Disorders, Post-Traumatic

Interventions

Wettability

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Hydrophobic and Hydrophilic Interactions; Chemical Phenomena; Surface Properties

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking -- as single group design, all participants receive the program.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group study, where all participants receive telehealth-based Written Exposure therapy (WET). Feasibility and initial efficacy is assessed via pre-post assessments, conducted pre-WET, at the end of WET, and 1 and 6 months post program completion.

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 17, 2023
• Study Start: October 26, 2023
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)