ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19

ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)

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).

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Autism Spectrum Disorder; Psychological Distress
• Intervention / Treatment: Behavioral: Emotional Support Plan; Behavioral: Daily Monitoring

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Rutgers University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotional Support Plan (ESP) + Weekly Monitoring; This will involve weekly assessments without prompting to use the plan.	Behavioral: Emotional Support Plan; 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.
Experimental: Emotional Support Plan (ESP) + 4x Daily Monitoring; 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	Behavioral: Emotional Support Plan; 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.; Behavioral: Daily Monitoring; The daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 week study period
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.	8 week study period
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.	8 week study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 week study period

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): February 9, 2022
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: smartphone; ecological momentary assessment (EMA); ecological momentary intervention (EMI)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Neurodevelopmental Disorders; Stress, Psychological; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: Pro2020001593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No