Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults

University of Pittsburgh

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: The Unified Protocol; Behavioral: The Emotion Awareness and Skills Enhancement Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06158581

STUDY23090024

IDD-2022C1-26418 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 470 estimated patients

Sex: All

Ages: 10 to 30 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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470 participants in 2 patient groups

The Emotion Awareness and Skills Enhancement

Experimental group

Description:

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.

Treatment:

Behavioral: The Emotion Awareness and Skills Enhancement Program

The Unified Protocol

Active Comparator group

Description:

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.

Treatment:

Behavioral: The Unified Protocol