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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:
Participants will complete the following as part of the study, which is completed entirely over telehealth.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Written Exposure Therapy | Experimental | Behavioral therapy: Written Exposure Therapy via telehealth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Written Exposure Therapy (WET) via telehealth | Behavioral | Written Exposure Therapy (WET) via telehealth |
|
| 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) |
| 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) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wyoming | Laramie | Wyoming | 82071 | United States |
Participants were excluded from the study prior to enrollment if they did not meet study inclusion criteria.
Autistic adults were enrolled in this study from October 2023 to July 2024. Participants were recruited through flyers and advertisements posted to social media, listservs, and clinic emails.
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| ID | Title | Description |
|---|---|---|
| FG000 | Written Exposure Therapy | Behavioral therapy: Written Exposure Therapy via telehealth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment to End of Intervention |
| |||||||||||||
| 1 Month Follow Up |
| |||||||||||||
| 6 Month Follow Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Written Exposure Therapy | Behavioral therapy: Written Exposure Therapy via telehealth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
|
From enrollment until end of follow-up, up to 6 months after intervention completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Written Exposure Therapy | Behavioral therapy: Written Exposure Therapy via telehealth |
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This study was a pilot feasibility study with a single arm pre-post design and a small sample size, with no randomization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina McDonnell | University of Wyoming | See email | christina.mcdonnell@uwyo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2026 | May 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D014947 | Wounds and Injuries |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017155 | Wettability |
| ID | Term |
|---|---|
| D057927 | Hydrophobic and Hydrophilic Interactions |
| D055598 | Chemical Phenomena |
| D013499 | Surface Properties |
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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.
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No masking -- as single group design, all participants receive the program.
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| 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) |
| 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) |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | Score on scale |
|
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
|
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
|
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
|
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
|
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|
| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
|
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Number of steps | 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) |
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Hours | 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) |
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| Secondary | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Beats per minute/day | 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) |
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| Other Pre-specified | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| Other Pre-specified | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| Other Pre-specified | 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. | The number of participants reported here may differ from the numbers reported in the Participant Flow because some participants did not complete all measures at all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 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) |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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