Emotion Awareness and Skills Enhancement Program

Study Overview
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Brief Summary
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This project will address impaired emotion regulation in adolescents with ASD (autism spectrum disorder). There are no evidence-based interventions to improve emotion regulation (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and function across all life settings, and reduce their quality of life and that of their families. The primary objective of this study is to formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled trial (RCT).

Detailed Description
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The current study is to test a new intervention called Emotional Awareness and Skills Enhancement (EASE). This program was designed to address ASD-specific obstacles to effective emotion regulation, such as reduced awareness concerning others' intentions, a limited repertoire of behavioral responses, and inadequate language for understanding emotional experiences. This new program is based on an acceptance-based approach in which awareness of emotion is developed, emotions (whether negative or positive) are accepted, and behavior is regulated in the face of intense emotion. The goal is not to learn to avoid negative emotions, but rather to develop a collection of abilities which allow the individual to manage stress and act in ways that are more adaptive. The investigators expect to find that participants' emotion dysregulation will decrease and their adaptive function will increase following completion of the EASE program.

Official Title
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Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: EASE
* Behavioral: Supportive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 12-21 years, inclusive A diagnosis of ASD (autism spectrum disorder), as defined by exceeding the ASD cutoff on the ADOS-2 (Autism Diagnostic Observation Scale) or ADI-R (Autism Diagnostic Interview-Revised) In. If the participant has completed the ADOS in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ADOS. Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 [WASI-2] FSIQ >=75). Fluent in the English language Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments. Exclusion Criteria: Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview. Previous or current diagnosis of a psychotic disorder. Receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. This will be assessed using current treatment items on the demographic forms.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: per protocol analysis versus intent to treat analytic approach due to the pandemic
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotion Awareness/Skills Enhancement<br>EASE Therapy includes 16 weekly sessions focused on mindfulness exercise, review of prior content, practicing prior skills, outline of current session, discussion of the new skill, handouts, practice and plan for out of session practice held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The investigators will apply a multimodal teaching approach, where individual therapy is buttressed by parent involvement and practice sessions in the youth's community. A secure website developed for this project (emotion-Coach or e-Coach) will augment the intervention by providing online supports to increase treatment intensity or dosage. There will be specific information on how to reinforce the skills at home and in the community. | Behavioral: EASE<br>* Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.<br>|
| Active Comparator: Supportive Therapy<br>Supportive Therapy will involve attending 16 weekly therapy sessions held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The intervention will not involve mindfulness or other emotion regulation strategies used in EASE. The therapy will be tailored to the individual's needs and will include aspects common in supportive therapy such as reflective listening, antecedent management, and problem-solving. This program does not have an online component. | Behavioral: Supportive Therapy<br>* Weekly behavioral sessions with a therapist to work on emotional control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Clinical Global Impression Scale- Improvement (CGI-I) | The CGI-I will be used as a measure of overall improvement. The CGI-I (Improvement) scale was designed to measure overall symptomatic change at a specific time as compared to baseline that is completed by a rater who is blind to treatment assignment. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). It is only a single item, and lower scores indicate more improvement. | The CGI-I will be completed at 16 weeks (post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF) | The EDI SF is a measure of emotional reactivity and regulation. The EDI SF is based on theta scores, with a mean of 0 and SD of 1 and possible range from -1.99 to 2.105. Higher scores suggest greater dysregulation, so improvement would be measured by a decrease in scores. | The EDI-SF will be completed at 16 weeks (post-treatment). | 
| Brief Psychiatric Rating Scale (BPRS) | The Brief Psychiatric Rating Scale (BPRS) is an interview-based measure of psychopathology severity widely used in clinical trials. It consists of 24 items that measure psychiatric symptoms, each of which are on a 1 (not reported) to 7 (very severe) scale, so that lower scores are an indication of improvement. An assignment naïve rater scores the items based upon client report and clinical observation. All scales ask about symptoms over the last 7 days. The single item on Global Improvement will be used. | The CGI-I will be completed at 16 weeks (post-treatment) |