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

Primary Purpose

Autism, Trauma, Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Exposure Therapy (WET) via telehealth
Sponsored by
University of Wyoming
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • University of WyomingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Written Exposure Therapy

Arm Description

Behavioral therapy: Written Exposure Therapy via telehealth

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 in loneliness symptoms on the University of California Los Angeles (UCLA) Loneliness Scale
The University of California Los Angeles (UCLA) is a self-report measure for symptoms of loneliness. Scores range from 0 to 60; higher scores reflect higher levels of loneliness.
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 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 in emotion regulation difficulties on the Difficulties in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation Scale (DERS) is a self-report measure of emotion regulation difficulties. Scores range from 36 to 180; higher scores reflect greater emotion regulation difficulties.
Change in stigma towards help-seeking on the Self-Stigma of Seeking Help (SSOSH) Scale
The Self-Stigma of Seeking Help (SSOSH) Scale is a self-report measure of stigma towards seeking psychological support. Scores range from 10 to 50; higher scores reflect greater stigma.
Change in stigma towards anxiety on the Skidmore Anxiety Stigma Scale (SASS)
The Skidmore Anxiety Stigma Scale (SASS) is a self-report measure of stigma or negative beliefs about anxiety. Scores range from 0 to 70; higher scores reflect greater anxiety stigma.
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 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 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 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 in pain behavior on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Behavior Scale.
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Behavior Scale is a 20-item measure of pain behavior. Scores range from 20 to 100; higher scores indicate more frequent pain behavior.
Change in health-related quality of life on the Centers for Disease Control Health-Related Quality of Life Scale (CDC HRQOL)
The Centers for Disease Control Health-Related Quality of Life Scale (CDC HRQOL) is a self-report of health-related quality of life (CDC HRQOL). The measure yields a number of unhealthy days (from 0 to 30); higher numbers reflect worse health-related quality of life.
Change in frequency of safety behaviors on the Safety Behavior Assessment Form
The Safety Behavior Assessment Form is a self-report questionnaire of the frequency of safety behaviors relating to PTSD. Total scores range from 0 to 123; higher scores reflect a higher frequency of safety behaviors.
Change in mental health symptoms on the clinician-administered Structured Clinical Interview for DSM-5
The Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders (DSM)-5 (SCID-5) is a clinical interview for symptoms of mental health diagnoses. The measure yields number of symptoms for which an individual meets criteria, and whether an individual meets diagnostic criteria, indicating that the person experiences a clinically significant amount of mental health symptom in a particular domain.
Change in physical activity as assessed on Fitbit.
Participants Fitbit measurements of number of steps will be assessed via their Fitbit device. A higher number of steps indicates a higher level of physical activity.
Change in sleep quality as assessed on Fitbit.
Participants Fitbit measurements of sleep quality will be assessed via their Fitbit device. A higher sleep quality indicates overall better sleep outcomes.
Change in sleep duration as assessed on Fitbit.
Participants Fitbit measurements of sleep duration in hours will be assessed via their Fitbit device. A higher sleep duration indicates greater numbers slept.
Change in resting heart rate as assessed on Fitbit.
Participants Fitbit measurements of resting heart rate will be assessed via their Fitbit device. Lower resting heart rate indicates a more positive health outcome.

Full Information

First Posted
April 25, 2023
Last Updated
August 13, 2023
Sponsor
University of Wyoming
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1. Study Identification

Unique Protocol Identification Number
NCT05862467
Brief Title
A Pilot Participatory Program Evaluation of a Virtual Trauma Support Program for Autistic Adults
Official Title
Efficacy of a Posttraumatic Stress Disorder (PTSD) Intervention for Autistic Adults on Biobehavioral Health
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wyoming

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Trauma, Posttraumatic Stress Disorder, Posttraumatic Stress Symptom

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
No masking -- as single group design, all participants receive the program.
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Written Exposure Therapy
Arm Type
Experimental
Arm Description
Behavioral therapy: Written Exposure Therapy via telehealth
Intervention Type
Behavioral
Intervention Name(s)
Written Exposure Therapy (WET) via telehealth
Intervention Description
Written Exposure Therapy (WET) via telehealth
Primary Outcome Measure Information:
Title
Change in posttraumatic stress disorder (PTSD) symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
Description
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.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Secondary Outcome Measure Information:
Title
Change in depressive symptoms on the Patient Health Questionnaire (PHQ) Scale
Description
The PHQ is a self-report measure of depressive symptoms. Total scores range from 0-27; higher scores reflect greater levels of depressive symptoms.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in anxiety symptoms on the Anxiety Scale for Autism-Adults (ASA-A)
Description
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.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in loneliness symptoms on the University of California Los Angeles (UCLA) Loneliness Scale
Description
The University of California Los Angeles (UCLA) is a self-report measure for symptoms of loneliness. Scores range from 0 to 60; higher scores reflect higher levels of loneliness.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in psychological adjustment concerns on the Brief Adjustment Scale (BASE-6)
Description
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.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in experiential avoidance symptoms on the Brief Experiential Avoidance Questionnaire
Description
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.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in emotion regulation difficulties on the Difficulties in Emotion Regulation Scale (DERS)
Description
The Difficulties in Emotion Regulation Scale (DERS) is a self-report measure of emotion regulation difficulties. Scores range from 36 to 180; higher scores reflect greater emotion regulation difficulties.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in stigma towards help-seeking on the Self-Stigma of Seeking Help (SSOSH) Scale
Description
The Self-Stigma of Seeking Help (SSOSH) Scale is a self-report measure of stigma towards seeking psychological support. Scores range from 10 to 50; higher scores reflect greater stigma.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in stigma towards anxiety on the Skidmore Anxiety Stigma Scale (SASS)
Description
The Skidmore Anxiety Stigma Scale (SASS) is a self-report measure of stigma or negative beliefs about anxiety. Scores range from 0 to 70; higher scores reflect greater anxiety stigma.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)
Description
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.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in sleep difficulties on the Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in pain intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.
Description
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.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in pain interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.
Description
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.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in pain behavior on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Behavior Scale.
Description
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Behavior Scale is a 20-item measure of pain behavior. Scores range from 20 to 100; higher scores indicate more frequent pain behavior.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in health-related quality of life on the Centers for Disease Control Health-Related Quality of Life Scale (CDC HRQOL)
Description
The Centers for Disease Control Health-Related Quality of Life Scale (CDC HRQOL) is a self-report of health-related quality of life (CDC HRQOL). The measure yields a number of unhealthy days (from 0 to 30); higher numbers reflect worse health-related quality of life.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in frequency of safety behaviors on the Safety Behavior Assessment Form
Description
The Safety Behavior Assessment Form is a self-report questionnaire of the frequency of safety behaviors relating to PTSD. Total scores range from 0 to 123; higher scores reflect a higher frequency of safety behaviors.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in mental health symptoms on the clinician-administered Structured Clinical Interview for DSM-5
Description
The Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders (DSM)-5 (SCID-5) is a clinical interview for symptoms of mental health diagnoses. The measure yields number of symptoms for which an individual meets criteria, and whether an individual meets diagnostic criteria, indicating that the person experiences a clinically significant amount of mental health symptom in a particular domain.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in physical activity as assessed on Fitbit.
Description
Participants Fitbit measurements of number of steps will be assessed via their Fitbit device. A higher number of steps indicates a higher level of physical activity.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in sleep quality as assessed on Fitbit.
Description
Participants Fitbit measurements of sleep quality will be assessed via their Fitbit device. A higher sleep quality indicates overall better sleep outcomes.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in sleep duration as assessed on Fitbit.
Description
Participants Fitbit measurements of sleep duration in hours will be assessed via their Fitbit device. A higher sleep duration indicates greater numbers slept.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in resting heart rate as assessed on Fitbit.
Description
Participants Fitbit measurements of resting heart rate will be assessed via their Fitbit device. Lower resting heart rate indicates a more positive health outcome.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Other Pre-specified Outcome Measures:
Title
Change in life satisfaction on the Satisfaction with Life Scale (SWLS)
Description
The Satisfaction with Life Scale (SWLS) is a self-report measure of life satisfaction. Scores range from 5 to 35; higher scores reflect great satisfaction.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in trait resilience on the Brief Resilience Scale (BRS)
Description
The Brief Resilience Scale (BRS) is a self-report measure of resilience. Total scores range from 6 to 30; higher scores reflect greater resilience.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in autistic quality of life on the Autism Spectrum Quality of Life Scale.
Description
The Autism Spectrum Quality of Life Scale is a self-report measure of quality of life relating to autism. Higher scores reflect greater quality of life.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in overall quality of life on the World Health Organization Quality of Life Scale
Description
The World Health Organization Quality of Life Scale (WHO QOL) is a 26-item self-report questionnaire of quality of life. Higher scores reflect greater quality of life.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
Change in positive Autistic identity on the Autism Spectrum Identity Scale (ASIS)
Description
The Autism Spectrum Identity Scale (ASIS) is a 22-item self-report of autistic identity; higher scores reflect a more positive Autistic identity.
Time Frame
Change across baseline to follow-up (an average of 6 months)
Title
End of program working alliance reported on the Working Alliance Inventory (Short-Revised)
Description
The Working Alliance Inventory is a self-report measure of therapeutic alliance. Scores range from 12 to 60; higher scores reflect a greater therapeutic alliance.
Time Frame
6 weeks (after baseline, on average)
Title
End of program satisfaction reported on the Program Satisfaction Questionnaire
Description
The Program Satisfaction Questionnaire assesses satisfaction with various aspects of the program.
Time Frame
6 weeks (after baseline, on average)
Title
History of adverse childhood experiences reported on the Adverse Childhood Experiences (ACEs) Checklist
Description
The Adverse Childhood Experiences checklist is a measure of ten adverse childhood experiences. Scores range from 0-10; higher scores reflect a greater number of adverse childhood experiences.
Time Frame
Baseline
Title
History of benevolent/positive childhood experiences reported on the Benevolent Childhood Experiences Checklist.
Description
The Benevolent Childhood Experiences checklist is a measure of 10 benevolent/positive childhood experiences. Scores range from 0-10; higher scores reflect greater positive childhood experiences.
Time Frame
Baseline
Title
History of adverse experiences on the Sexual and Gender Minority Adverse Childhood Experiences Scale
Description
The Sexual and Gender Minority Adverse Childhood Experiences Scale (SGM-ACEs) contains 7 items rated as present or not, and on a scale from never to always. Total scores range from 0 to 35; higher scores reflect a greater frequency of adverse experiences.
Time Frame
Baseline
Title
Racial trauma symptoms on the Racial Trauma Scale (RTS)
Description
The Racial Trauma Scale is a self-report measure of racial trauma symptoms. Scores range from 30 to 120; higher scores reflect a higher level of symptoms.
Time Frame
Baseline
Title
Discrimination experiences on the Everyday Discrimination Scale (EDS)
Description
The Everyday Discrimination Scale (EDS) is a 9-item scale of experiences of discrimination. Scores range from 0 to 45; greater scores indicate more experiences of discrimination.
Time Frame
Baseline
Title
History of stressful and traumatic experiences on the Vulnerability Experiences Quotient (VEQ)
Description
The Vulnerability Experiences Quotient (VEQ) is a 60-item self-report measure that assesses whether or not an individual has experienced a range of stressful or traumatic events. Total scores range from 0-60; higher scores reflect a greater number of stressful or traumatic experiences.
Time Frame
Baseline
Title
History of childhood stressful experiences on the Childhood Experiences Survey
Description
The Childhood Experiences Survey is a 17-item measure that assesses the frequency of stressful childhood experiences. Higher scores reflect a greater frequency of stressful experiences.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Facility Information:
Facility Name
University of Wyoming
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
Phone
307-314-9218
Email
christina.mcdonnell@uwyo.edu
First Name & Middle Initial & Last Name & Degree
Director of Research Services
Phone
3077662047
Email
fgraf@uwyo.edu

12. IPD Sharing Statement

Learn more about this trial

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

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