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OpenTrials
Completed

NCT Number: NCT04460677

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

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).

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Key information

Conditions

Psychological Distress Autism Spectrum Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

Piscataway, New Jersey, 08854, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Daily Monitoring

Behavioral

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

Primary outcomes

  1. Decreased distress on Patient Health Questionnaire (PHQ-9)

    Time frame: 8 week study period

    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.

  2. Decreased distress on EMA reports

    Time frame: 8 week study period

    EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.

  3. Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)

    Time frame: 8 week study period

    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 outcomes

  1. Adult Self Report (ASR)

    Time frame: 8 week study period

    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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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