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

NCT04460677 | Completed

• 1 other identifier: Pro2020001593
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Psychological Distress; Stress, Psychological; Autism Spectrum Disorder

Keywords

smartphone; ecological momentary intervention (EMI); ecological momentary assessment (EMA)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adult Self Report (ASR)

  8 week study period

Study Arms (2)

Emotional Support Plan (ESP) + Weekly Monitoring

EXPERIMENTAL

This will involve weekly assessments without prompting to use the plan.

Behavioral: Emotional Support Plan

Emotional Support Plan (ESP) + 4x Daily Monitoring

EXPERIMENTAL

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; Behavioral: Daily Monitoring

Interventions

Emotional Support Plan BEHAVIORAL

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.

Emotional Support Plan (ESP) + 4x Daily Monitoring; Emotional Support Plan (ESP) + Weekly Monitoring

Daily Monitoring BEHAVIORAL

The daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed.

Emotional Support Plan (ESP) + 4x Daily Monitoring

Eligibility Criteria

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 7, 2020
• Study Start: August 12, 2020
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)