Clinical trial NCT06158581: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Alabama, Tuscaloosa
name: Patient-Centered Outcomes Research Institute
First posted: 2023-12-06
Enrollment: 470
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

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.
* Participants must live in Alabama or Pennsylvania.

Exclusion Criteria:

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

Primary outcomes:
measure: Emotion Dysregulation Inventory
timeFrame: Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Weiner's Acceptability, Appropriateness, & Feasibility of Intervention Scales
timeFrame: Baseline and Post treatment of first client (after all 16 sessions, average 16-20 weeks)
measure: Provider Self-Efficacy Scale
timeFrame: Baseline and Post trial (4 years)
Secondary outcomes:
measure: Clinical Global Impressions
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
measure: PROMIS Depression
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: PROMIS Anxiety
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Buss-Perry Aggression Questionnaire
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Emotion Regulation Questionnaire for Children and Adolescents
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Child & Adolescent Mindfulness Measure
timeFrame: Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks)
measure: WHO Quality of Life-BREF-ID
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Satisfaction with Life Scale
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
measure: Self-Compassion Scale-Youth Version
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Relationships, Employment, Autonomy, and Life Satisfaction
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
measure: AASPIRE Flourishing Scale
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: AASPIRE Burnout Scale Short Form
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Credibility and Expectancy Questionnaire
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
measure: AASPIRE Patient Health Questionnaire-9
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Inventory of Statements about Self-Injury
timeFrame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
measure: Working Alliance Inventory
timeFrame: Midpoint (after completing 8 sessions, average 8 weeks), After completing 15 sessions (average 15-19 weeks)
measure: Vanderbilt Therapeutic Alliance Scales Revised, Short Form
timeFrame: 2 randomized timepoints over up to 20 Weeks
measure: Child Involvement Rating Scale
timeFrame: 2 randomized timepoints over up to 20 Weeks
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Carla Mazefsky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Susan White, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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.