Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

Study Overview
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Brief Summary
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Too few clinicians are able and willing to help autistic patients. A recent review identified challenges to mental health service delivery in autism, including a lack of interventions designed for community implementation and limited workforce capacity. It has been argued that improving impairment in emotion regulation has the potential to improve a range of mental health difficulties in autistic people. In this clinical trial we are comparing two evidence-based interventions for emotion regulation, to determine if one created specifically for autistic people is clinically superior. The interventions will be implemented in the community, through partnering agencies.

Detailed Description
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This study will compare the effectiveness of two transdiagnostic interventions for autistic adolescents and young adults - an intervention in widespread use among non-autistic populations (The Unified Protocol; UP) versus an autism-specific intervention (The Emotion Awareness and Skills Enhancement Program; EASE). The UP and EASE are ideal comparators because they are structurally equivalent and transdiagnostic - both shown to improve mental health outcomes that stakeholders identify as important, such as depression, irritability, and anxiety. We will partner with 10 different community clinics in Pennsylvania and Alabama to recruit participants and facilitate the interventions. Each clinic will be randomized to use either UP or EASE. We will look at effectiveness of the treatments, as well as the feasibility, benefits and harms.

Official Title
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The Emotion Awareness and Skills Enhancement (EASE) Program Versus the Unified Protocol (UP)

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: The Emotion Awareness and Skills Enhancement Program
* Behavioral: The Unified Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: professional diagnosis of ASD a score in the clinical range on the EDI-Reactivity (7 item) or Dysphoria scale (6 item) based on caregiver report communicative ability (verbal or nonverbal) Clinician judgment that person could meaningfully participate and potentially benefit A caregiver or other adult with consistent contact who can complete assessments Client must live in Alabama or Pennsylvania Home access to internet and device for online assessments and meetings Exclusion Criteria: acute psychosis imminent suicide/homicide threat intoxication mania

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Emotion Awareness and Skills Enhancement<br>EASE is a 16-session mindfulness-based intervention (MBI). It emphasizes a small set of core concepts (i.e., mindfulness practices, distress tolerance, encouraging helpful thoughts, self-compassion) that are repeated with consistent language throughout. Emphasis is placed on increasing awareness of gradients of emotional arousal. | Behavioral: The Emotion Awareness and Skills Enhancement Program<br>* EASE is a cutting-edge program created by researchers at the University of Alabama and the University of Pittsburgh in collaboration with autistic individuals, caregivers of autistic youth, and therapists. The overarching goal of the program is to support autistic clients who want to work on emotion regulation. EASE is unique because it targets emotional distress in autistic youth and adults, instead of targeting the core symptoms of autism (i.e., it is not a social skills intervention). The program is a 16-session, mindfulness-based intervention. Each session is 1:1 for 45 minutes to one hour. While the program is designed for individual intervention, caregivers are also invited to play an active role on the care team.<br>* Other names: EASE;|
| Active Comparator: The Unified Protocol<br>UP is a 12-21 session cognitive behavioral therapy (CBT) based treatment. In this study, there will be 16 sessions. UP is focused on identifying emotions and building new coping strategies. It is customizable to meet the needs of the individual. | Behavioral: The Unified Protocol<br>* UP is a thoroughly-studied, manualized intervention created by researchers at the University of Miami in conjunction with researchers at Boston University. The program was designed to be customizable to meet the needs of people with a variety of diagnoses, allowing more individuals to access emotion regulation resources. The protocol also has different modules to accommodate different developmental levels (UP-Children, UP-Adolescent, UP-Adult). The overall goal of UP is to help clients identify emotions and build new strategies to cope with stressful life situations and distressing emotions. The protocol is flexible, with each session is about 45 to 60 minutes and the number of sessions varying between 12 - 21 sessions. For the current study, the treatment will take place over 16 sessions. The intervention is cognitive behavioral therapy (CBT) based but also includes hints of mindfulness-based intervention strategies.<br>* Other names: UP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion Dysregulation Inventory | The EDI does not have a single overall score. It is comprised of two scales: Reactivity and Dysphoria. Items are on a 0 to 4 scale, where 0 is Never happens and 4 is Almost always happens or causes a serious problem. There are clinical cutoffs for both scales. | Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment | 
| Weiner's Acceptability, Appropriateness, & Feasibility of Intervention Scales | Weiner's is a widely used 12-item battery of three scales assessing intervention acceptability, appropriateness, and feasibility with strong psychometric properties. There is a 1 to 5 scale, where 1 is Completely disagree and 5 is Completely agree. Higher scores indicate greater acceptability, appropriateness, and feasibility. | Post treatment (after all 16 sessions, average 16-20 weeks) | 
| Provider Self-Efficacy Scale | It assesses both knowledge (of protocol) and confidence (in one's ability to implement as intended). It is a 0-10 scale, where 0 is not at all confident and 10 is extremely confident. Higher scores indicate higher confidence. | Baseline and Post trial (4 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions | The CGI will be used as a measure of overall improvement. The CGI 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. | Post treatment (after all 16 sessions, average 16-20 weeks) | 
| Columbia-Suicide Severity Rating Scale | C-SSRS is a widely used interview of the frequency and severity of suicidal ideation and behaviors. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment | 
| PROMIS Depression | It is a brief, change sensitive 8 item measure. It is a 1-5 scale, where 1 is Never and 5 is Always. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment | 
| PROMIS Anxiety | It is a brief, change sensitive 8 item measure. It is a 1-5 scale, where 1 is Never and 5 is Always. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment | 
| Buss-Perry Aggression Questionnaire | 27-item self-report measure of general aggression, physical aggression, verbal aggression, anger, and hostility. It is a 1-7 scale, where 1 is Extremely uncharacteristic of me and 7 is Extremely characteristic of me. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment | 
| Emotion Regulation Questionnaire | ERQ has10 items that comprise of two scales: cognitive reappraisal use and expressive suppression, which are two regulatory strategies considered adaptive and protective in terms of mental health. It is a 1-7 scale, where 1 is Strongly disagree and 7 is Strongly agree. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment | 
| Child & Adolescent Mindfulness Measure | CAMM is a 10-item self-report measure of mindfulness. It is a 0-4 scale, where 0 is Never true and 4 is Always true. When scoring, you reverse all scores (i.e. 0 to 4) and then sum. Higher scores correspond to higher levels of mindfulness. | Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks) | 
| WHO Quality of Life-BREF-ID | WHOQoL-BREF-ID is a simplified version of the World Health Organization Quality of Life. It has a 3 or 5 point visual response scale, where 1 is Not at all and 5 is Totally. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks) | 
| Satisfaction with Life Scale | Satisfaction was Life Scale is a 5-item measure of global life satisfaction. It is a 1-7 scale, where 1 is Strongly disagree and 7 is Strongly agree. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks) | 
| Self-Compassion Scale-Youth Version | Self-Compassion Scale - Youth Version consists of 17 self-report items ranked on a 5-point Likert scale, yielding six subscales (self-kindness, self-judgment, common humanity, isolation, mindfulness, over-identification) and an overall score. 1 is Almost Never and 5 Almost Always. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks) | 
| Relationships, Employment, Autonomy, and Life Satisfaction | REALS Measures are a compilation of scales tapping many areas of adult life. Each scale is scored independently and should be utilized as different sources of information. It does not produce a global outcome score. With the frequency scales, it is a 0-4 scale where 0 is Never and 4 is Always. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks) | 
| AASPIRE Flourishing Scale | It is 9 item scale that assesses aspects of life satisfaction for autistic individuals. It is a scale from strongly disagree to strongly agree. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment | 
| AASPIRE Burnout Scale Short Form | It is a 14-item self-report measure of autistic burnout. It is a scale from strongly disagree to strongly agree. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment | 
| Credibility and Expectancy Questionnaire | It will assess treatment expectancy and rationale for the assessed treatments. | Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment |