Clinical trial NCT03432832: Emotion Awareness and Skills Enhancement Program
Official title: Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2018-02-14
Enrollment: 113
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: per protocol analysis versus intent to treat analytic approach due to the pandemic
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. ages 12-21 years, inclusive
2. 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.
3. Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 \[WASI-2\] FSIQ \>=75).
4. Fluent in the English language
5. Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.

Exclusion Criteria:

1. Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.
2. Previous or current diagnosis of a psychotic disorder.
3. 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.

Primary outcomes:
measure: The Clinical Global Impression Scale- Improvement (CGI-I)
timeFrame: The CGI-I will be completed at 16 weeks (post-treatment)
measure: Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF)
timeFrame: The EDI-SF will be completed at 16 weeks (post-treatment).
Secondary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: The CGI-I will be completed at 16 weeks (post-treatment)
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
city: Pittsburgh
country: United States
facility: Shannondora Porton
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Carla Mazefsky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Susan White
role: PRINCIPAL_INVESTIGATOR
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