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Emotional Support Plan for Autism Spectrum Disorder

N/A

Waitlist Available

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 week study period

Awards & highlights

No Placebo-Only Group

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).

Eligible Conditions

Autism Spectrum Disorder
Life Stress
Stress
Psychological Distress
Autism

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 week study period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 week study period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 week study period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Decreased distress on EMA reports

Decreased distress on Patient Health Questionnaire (PHQ-9)

Secondary study objectives

Adult Self Report (ASR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Emotional Support Plan (ESP) + Weekly MonitoringExperimental Treatment1 Intervention

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

Group II: Emotional Support Plan (ESP) + 4x Daily MonitoringExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emotional Support Plan

2020

N/A

~30

Daily Monitoring

2020

N/A

~30