Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158581
• Other study ID #: STUDY23090024
• Secondary ID: IDD-2022C1-26418
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: August 1, 2027

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Kara Duman, MSW
• Phone: 1-866-647-3436
• Email: emotiontherapy[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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, the investigators 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.

Description:

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. The investigators 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. The investigators will look at effectiveness of the treatments, as well as the feasibility, benefits and harms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

Inclusion Criteria:

• professional diagnosis of ASD

• a score in the clinical range on the EDI-Reactivity or EDI-Dysphoria scale based on caregiver report or self-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

Exclusion Criteria:

• acute psychosis

• imminent suicide/homicide threat

• intoxication

• mania

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• The Emotion Awareness and Skills Enhancement Program
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.
• The Unified Protocol
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Alabama	Tuscaloosa	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Patient-Centered Outcomes Research Institute, University of Alabama, Tuscaloosa

Country where clinical trial is conducted

United States, 

References & Publications (4)

Barlow DH, Farchione T, Sauer-Zavala, Shannon Murray Latin H, et al. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. Second Edi. Oxford University Press; 2017.

Conner CM, White SW, Beck KB, Golt J, Smith IC, Mazefsky CA. Improving emotion regulation ability in autism: The Emotional Awareness and Skills Enhancement (EASE) program. Autism. 2019 Jul;23(5):1273-1287. doi: 10.1177/1362361318810709. Epub 2018 Nov 7. — View Citation

Ehrenreich-May J, Kennedy SM, Sherman JA, et al. Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents: Therapist Guide. Oxford University Press; 2017.

Ellard KK, Fairholme CP, Boisseau CL, Farchione TJ, Barlow DH. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: Protocol Development and Initial Outcome Data. Cogn Behav Pract. 2010 Feb;17(1):88-101. doi: 10.1016/j.cbpra.2009.06.002. Epub 2010 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	Baseline and Post treatment of first client (after all 16 sessions, average 16-20 weeks)
Primary	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	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.	Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
Secondary	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
Secondary	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
Secondary	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
Secondary	Emotion Regulation Questionnaire for Children and Adolescents	ERQ-CA 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
Secondary	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)
Secondary	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), 3 months following post-treatment
Secondary	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)
Secondary	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), 3 months following post-treatment
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	AASPIRE Patient Health Questionnaire-9	This is a 9-item self-report questionnaire for screening, diagnosing, monitoring and measuring the severity of depression, that includes an item that is widely utilized as an index of suicidal ideation severity. Each item is rated on a scale from Rarely or not at all to Almost every day. Higher scores would relate to higher depression.	Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Secondary	Inventory of Statements about Self-Injury	ISAS is a continuous self-report measure of self-injurious behaviors. It is the most commonly used measure of self-injury. Higher numbers in Section 1 would indicate more self-injurious behaviors.	Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Secondary	Working Alliance Inventory	WAI is a clinician-report measure assessing the therapeutic alliance between the client/participant and the clinician. The measure is 12 items, rated on a 5-point scale.	Midpoint (after completing 8 sessions, average 8 weeks), After completing 15 sessions (average 15-19 weeks)
Secondary	Vanderbilt Therapeutic Alliance Scales Revised, Short Form	VTAS-R-SF is an observational measure of alliance and consists of five items to capture the strength of the perceived support and trust, participation, and agreement on tasks and goals between client and therapist. Each item is rated 0-5, and higher scores mean more alliance. The measure is used for coding videos of the therapy sessions. It will be completed twice with each participant but the timepoint is randomized (one randomized session from the first half of therapy and one randomized session from the second half of therapy).	2 randomized timepoints over up to 20 Weeks
Secondary	Child Involvement Rating Scale	Child Involvement Rating Scale is a 10-item, 6-point observational scale to rate involvement and engagement during therapy. The first 6 items rate positive involvement where 0 is not at all and 5 is a great deal. The last 4 items rate negative involvement where 0 is not at all and 5 is a great deal. The measure is used for coding videos of the therapy sessions. The measure will be completed twice with each participant but the timepoint is randomized (one randomized session from the first half of therapy and one randomized session from the second half of therapy).	2 randomized timepoints over up to 20 Weeks