Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

Official title

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

Overview

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.

Detailed 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 12 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.

Interventions

• 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 pr
• Behavioral 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

Primary outcome measures

• Emotion Dysregulation Inventory [Time frame: 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 [Time frame: Baseline and Post treatment of first client (after all 16 sessions, average 16-20 weeks)]
• Provider Self-Efficacy Scale [Time frame: Baseline and Post trial (4 years)]

Secondary outcome measures (12)

• Clinical Global Impressions [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)]
• PROMIS Depression [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment]
• PROMIS Anxiety [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment]
• Buss-Perry Aggression Questionnaire [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment]
• Emotion Regulation Questionnaire for Children and Adolescents [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment]
• Child & Adolescent Mindfulness Measure [Time frame: Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks)]
• WHO Quality of Life-BREF-ID [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment]
• Satisfaction with Life Scale [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)]
• Self-Compassion Scale-Youth Version [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment]
• Relationships, Employment, Autonomy, and Life Satisfaction [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)]
• AASPIRE Flourishing Scale [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment]
• AASPIRE Burnout Scale Short Form [Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment]

Eligibility criteria

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
• The study is open to people with a range of communication abilities. Participants must be able to consent to the study themselves and answer questions about themselves.
• Participants need to have a support person that could answer questions about them too. This could be a parent, caregiver, family member, partner or friend. Independent adults can opt out of this portion.
• Participants must live in Alabama or Pennsylvania.

Exclusion criteria

\- Higher level of care is needed (Imminent Suicide / Homicide Threat, acute psychosis, mania)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• University of Alabama — Tuscaloosa
• University of Pittsburgh — Pittsburgh

Publications

• 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. PMID 30400749
• 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. PMID 33762811
• 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.
• 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.
• Mazefsky CA, Bradley M, Duman K, Beck KB, Conner CM, Powell N, Siegle GJ, Jones S, Trabert C, Tonarely-Busto N, Shaw AM, de Abril Cameron F, Kolko DJ, Kang C, Ehrenreich-May J, Farchione TJ, White SW. Study protocol for a comparative effectiveness randomized controlled trial comparing the emotion awareness and skills enhancement program to the unified protocol in autistic youth and young adults wi PMID 41514468

Identifiers

NCT: NCT06158581 · STUDY23090024 · IDD-2022C1-26418

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗