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

NCT ID: NCT04460677

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-12
• Study Completion Date: 2022-02-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Emotional Support Plan (ESP) + Weekly Monitoring

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

Group Type: EXPERIMENTAL

Emotional Support Plan

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Emotional Support Plan

Intervention Type: 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.

Daily Monitoring

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Daily Monitoring

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Vanessa H. Bal, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rutgers University

Piscataway, New Jersey, United States

Countries

United States

Other Identifiers

Pro2020001593

Identifier Type: -

Identifier Source: org_study_id