CLINICAL TRIAL

Emotional Support Plan - Self Guided (ESP-S) for Autism Spectrum Disorder

Recruiting · Any Age · All Sexes · Piscataway, NJ

This study is evaluating whether a program that provides emotional support can help autistic students.

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About the trial for Autism Spectrum Disorder

Eligible Conditions
Autism Spectrum Disorder · Depression, Anxiety

Treatment Groups

This trial involves 3 different treatments. Emotional Support Plan - Self Guided (ESP-S) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Emotional Support Plan - Clinician Guided (ESP-C)
BEHAVIORAL
Experimental Group 2
Emotional Support Plan - Self Guided (ESP-S)
BEHAVIORAL
Experimental Group 3
Emotional Support Plan - Clinician Guided (ESP-C)
BEHAVIORAL

Eligibility

This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Previous ASD diagnosis
Has smartphone (to access the ESP app)
At least 6th grade Reading Comprehension on the WRAT-5. The WRAT-5 may not be required if a student has other evidence of age-appropriate reading level.
Be currently enrolled in a Postsecondary Education (PSE) institution.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 15 week monitoring period
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 week monitoring period
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 15 week monitoring period.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Emotional Support Plan - Self Guided (ESP-S) will improve 3 primary outcomes and 4 secondary outcomes in patients with Autism Spectrum Disorder. Measurement will happen over the course of 15 week monitoring period.

Change Young Adult Coping Orientation for Problem Experience (YA-COPE)
15 WEEK MONITORING PERIOD
The YA-COPE is a 56-item measure designed to capture coping behaviors of college students. Items are rated on a scale of 1(never) to 5 (most of the time. Higher scores indicate more positive strategies.
15 WEEK MONITORING PERIOD
Change in Emotion Dysregulation Inventory
15 WEEK MONITORING PERIOD
The EDI is a measure of emotion dysregulation designed for use with individuals with autism. Items are rated on a scale of 0-5. Higher score equal more symptoms.
15 WEEK MONITORING PERIOD
Change in Adult Behavior Checklist
15 WEEK MONITORING PERIOD
The ABCL is a caregiver-report 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. Higher scores equal more symptoms.
15 WEEK MONITORING PERIOD
Change in Adult Self Report
15 WEEK MONITORING 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. Higher scores equal more symptoms.
15 WEEK MONITORING PERIOD
Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
15 WEEK MONITORING 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.
15 WEEK MONITORING PERIOD
Change in distress on Ecological Momentary Assessment (EMA) reports
15 WEEK MONITORING PERIOD
EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring groups only). Scores range from 0(not at all) to 5 (very much). Higher scores on the item equal higher levels of distress.
15 WEEK MONITORING PERIOD
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Who is running the study

Principal Investigator
V. H. B.
Prof. Vanessa H. Bal, PhD
Rutgers, The State University of New Jersey

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of autism spectrum disorder?

This sample highlights the broad range of developmental disorders of the autistic spectrum. The autism spectrum (with a high degree of comorbidity with other developmental disorders) may be a more "typical" case of developmental disorder.

Anonymous Patient Answer

What are common treatments for autism spectrum disorder?

A common treatment for autism spectrum disorder is the administration of a stimulant medication, such as an antipsychotic agent, or an antipsychotic medication plus an MAOI. This may be a first-line treatment for patients with non-autistic severe autism. Antipsychotics are also sometimes used for children with autism whom do not respond to medication or other options. Other treatment options for Autism Spectrum Disorder include behavioral intervention and/or occupational therapy.

Anonymous Patient Answer

Can autism spectrum disorder be cured?

The majority of children diagnosed with ASD will demonstrate significant improvement with appropriate intervention, at least long-term before they are considered to have recovered from the condition.

Anonymous Patient Answer

What causes autism spectrum disorder?

The causes of ASD are still unknown. Some of what we know about ASD is due to genetics, most of it being found in boys and in premature births. There is a possibility that prenatal exposures and nutritional problems may have played a role in the disease. There is also a possible role for infections such as rubella or cytomegalovirus during pregnancy in relation to the development of the disease. The evidence of infectious agents or exposure to environmental factors as the cause of ASD is currently not widely accepted. There is evidence that the development of ASD can be influenced by genes; and that the risk of the disease may be increased during pregnancy.

Anonymous Patient Answer

How many people get autism spectrum disorder a year in the United States?

The estimated prevalence of ASD in the general population is around 1% and the prevalence of ASD amongst adults is around 5%. The number of new diagnoses of ASD/ASD are estimated at over 15,000 a year.

Anonymous Patient Answer

What is autism spectrum disorder?

Those with ASD have specific behaviours and impairments but there is not a clear pattern to their symptoms and they sometimes have similar symptoms as other children with developmental delays such as Down Syndrome, Rett syndrome and fragile X syndrome. The condition may have a genetic basis which will affect the development of the brain and other organs, and is usually noticed early on and treated by family physicians and paediatricians. The disorder, as with other autism spectrum disorders, can affect the communication and social interaction between parents and their children and between a person with the disorder and their family. Most people with ASD have mild or moderate disabilities and require lifelong support, with parents ideally taking an active part in helping.

Anonymous Patient Answer

What does emotional support plan - self guided (esp-s) usually treat?

There is little evidence yet that esp-s, given with the same [training], affect change in autism spectrum disorder, and thus, there is no scientific basis for esp-s currently as a treatment. [Emotional Support Plan Self-guided (Enc-s)- self guided (self-empl-s)]

Anonymous Patient Answer

What is the latest research for autism spectrum disorder?

Although no current treatment approaches are known to prevent the development of ASD, research has been done on the causes and ways to prevent the onset or worsening of the disorder, so that treatments such as drugs, therapy or dietary supplements may become a reality. Current research is looking at the following aspects: [reactive] environmental factors, gene-environment interactions, the function of autoantibodies in ASD, [reactive] gut-brain interactions, new therapies and the development of more accurate diagnostic tests and biomarkers.

Anonymous Patient Answer

Who should consider clinical trials for autism spectrum disorder?

Clinically relevant outcomes are measured in ASD clinical trials, including cognitive development, social skills, and adaptive behavior. These outcomes should be tested in future trials. Clinically meaningful outcomes also demonstrate that the trial protocol should include an open-label extension of the study, lasting a minimum of one year beyond the end of the trial. Clinicians evaluating potential clinical trial candidates for autism spectrum disorders should consider assessment of cognitive development, social skills, adaptive behavior, and adverse effects as potential trial outcomes, because they demonstrate the most promise for achieving meaningful patient outcomes, even with treatment. Clinical Trial Registration Number: (NCT00228625).

Anonymous Patient Answer

Has emotional support plan - self guided (esp-s) proven to be more effective than a placebo?

Self-guided ESP - esp (Empowerment Support PeiNing) is a feasible approach to empower clients and increase their confidence. This was shown to be more effective than a placebo intervention.

Anonymous Patient Answer

How serious can autism spectrum disorder be?

While the spectrum of ASD and the severity of certain symptoms can range from the mild to debilitating, there are important factors to consider in assessing the severity of ASD. There is also a large body of evidence to support early diagnosis and implementation of interventions, particularly in cases of mild to moderate symptoms. However, we need to better understand the heterogeneity of ASD, specifically in children who are at an earlier stage in developmental delay.

Anonymous Patient Answer

Have there been other clinical trials involving emotional support plan - self guided (esp-s)?

Results from a recent paper suggested that in addition to ESSP, more studies would be fruitful, particularly a higher number of randomized controlled trials for long term studies with stronger evidence and methodological quality than the present study.

Anonymous Patient Answer
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