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

Not Applicable

Completed

• Conditions: Psychological Distress; Stress, Psychological; Autism Spectrum Disorder
• Interventions: Behavioral: Emotional Support Plan; Behavioral: Daily Monitoring

• Registration Number: NCT04460677
• Lead Sponsor: Rutgers, The State University of New Jersey

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-07
• Study Start: 2020-08-12
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emotional Support Plan (ESP) + 4x Daily Monitoring	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
Emotional Support Plan (ESP) + 4x Daily Monitoring	Emotional Support Plan	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
Emotional Support Plan (ESP) + Weekly Monitoring	Emotional Support Plan	This will involve weekly assessments without prompting to use the plan.

Primary Outcome Measures

Name	Time	Method
Decreased distress on Patient Health Questionnaire (PHQ-9)	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	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)	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 Outcome Measures

Name	Time	Method
Adult Self Report (ASR)	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.

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 Piscataway, New Jersey, United States