Back to resultsASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19
Primary Purpose
Psychological Distress, Stress, Psychological, Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Support Plan
Daily Monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Psychological Distress focused on measuring smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)
Eligibility Criteria
Inclusion Criteria Adults 18 years or older with previously established diagnoses in ASD will be invited to participate. Adults who have a verbal IQ above 70 or who are students admitted to a college or university will be included in the study.
Exclusion Criteria
- Individuals who are younger than 18 years old or who does not have diagnosis of ASD will excluded from the study as the purpose of the current research is to evaluate the validity of ESPs in adults with autism.
- Adults who are unable to understand English will be excluded because the instruments being investigated are currently only validated in English and the study team is not sufficiently fluent in other languages to provide assurance that informed consent could be obtained (or intervention provided) in a language besides English.
- Subjects without access to a compatible iOS and Android smartphone (nearly all phones from the past 10 years are compatible) will be excluded because the study requires subjects to record responses on a smartphone app. Individuals will not be excluded from the study based on race, ethnicity or gender.
- Subjects who have a verbal IQ below 70 will be excluded as this is a study that requires self-report and engagement in a one-on-one intervention.
- If the PI's clinical judgment is that it would not be in the adult's best interest to be enrolled, they may also be excluded.
Sites / Locations
- Rutgers University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Emotional Support Plan (ESP) + Weekly Monitoring
Emotional Support Plan (ESP) + 4x Daily Monitoring
Arm Description
This will involve weekly assessments without prompting to use the plan.
Participants in this arm will be prompted on their phones 4x/day randomly, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt
Outcomes
Primary Outcome Measures
Decreased distress on Patient Health Questionnaire (PHQ-9)
The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress.
Decreased distress on EMA reports
EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.
Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more anxiety.
Secondary Outcome Measures
Adult Self Report (ASR)
The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.
Full Information
NCT ID
NCT04460677
First Posted
July 6, 2020
Last Updated
August 9, 2022
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04460677
Brief Title
ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19
Official Title
ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
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 purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress, Stress, Psychological, Autism Spectrum Disorder
Keywords
smartphone, ecological momentary intervention (EMI), ecological momentary assessment (EMA)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emotional Support Plan (ESP) + Weekly Monitoring
Arm Type
Experimental
Arm Description
This will involve weekly assessments without prompting to use the plan.
Arm Title
Emotional Support Plan (ESP) + 4x Daily Monitoring
Arm Type
Experimental
Arm Description
Participants in this arm will be prompted on their phones 4x/day randomly, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt
Intervention Type
Behavioral
Intervention Name(s)
Emotional Support Plan
Intervention Description
The Emotional Support Plan (ESP) is designed to help adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic.
Intervention Type
Behavioral
Intervention Name(s)
Daily Monitoring
Intervention Description
The daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed.
Primary Outcome Measure Information:
Title
Decreased distress on Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress.
Time Frame
8 week study period
Title
Decreased distress on EMA reports
Description
EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.
Time Frame
8 week study period
Title
Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more anxiety.
Time Frame
8 week study period
Secondary Outcome Measure Information:
Title
Adult Self Report (ASR)
Description
The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.
Time Frame
8 week study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Adults 18 years or older with previously established diagnoses in ASD will be invited to participate. Adults who have a verbal IQ above 70 or who are students admitted to a college or university will be included in the study.
Exclusion Criteria
Individuals who are younger than 18 years old or who does not have diagnosis of ASD will excluded from the study as the purpose of the current research is to evaluate the validity of ESPs in adults with autism.
Adults who are unable to understand English will be excluded because the instruments being investigated are currently only validated in English and the study team is not sufficiently fluent in other languages to provide assurance that informed consent could be obtained (or intervention provided) in a language besides English.
Subjects without access to a compatible iOS and Android smartphone (nearly all phones from the past 10 years are compatible) will be excluded because the study requires subjects to record responses on a smartphone app. Individuals will not be excluded from the study based on race, ethnicity or gender.
Subjects who have a verbal IQ below 70 will be excluded as this is a study that requires self-report and engagement in a one-on-one intervention.
If the PI's clinical judgment is that it would not be in the adult's best interest to be enrolled, they may also be excluded.
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19
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