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Clinical Trials/NCT04460677
NCT04460677
Completed
N/A

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

Rutgers, The State University of New Jersey1 site in 1 country26 target enrollmentAugust 12, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychological Distress
Sponsor
Rutgers, The State University of New Jersey
Enrollment
26
Locations
1
Primary Endpoint
Decreased distress on Patient Health Questionnaire (PHQ-9)
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 12, 2020
End Date
February 9, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vanessa H. Bal, PhD

Assistant Professor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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

  • Adult Self Report (ASR)(8 week study period)

Study Sites (1)

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