Evidence map›Paper›PMID 41514468›Full record

ArticleBMC psychology2026

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 with emotion dysregulation.

Carla A Mazefsky, Madison Bradley, Kara Duman, Kelly B Beck, Caitlin M Conner, Nicole Powell, Greg J Siegle, Shannon Jones, Caitlin Trabert, Niza Tonarely-Busto and 7 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06158581 (The Emotion Awareness and Skills Enhancement), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06158581 narecruitingnot on this map

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

TypeinterventionalSponsorUniversity of PittsburghRan2024 to 2027Enrolled470ConditionsAutism Spectrum DisorderArmsThe Emotion Awareness and Skills Enhancement Program, The Unified Protocol
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Carla A MazefskyDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA. mazefskyca@upmc.edu.
Madison BradleyDepartment of Psychology, University of Alabama, Tuscaloosa, AL, USA.
Kara DumanDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
Kelly B BeckDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
Caitlin M ConnerDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
Nicole PowellDepartment of Psychology, University of Alabama, Tuscaloosa, AL, USA.
Greg J SiegleDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
Shannon JonesDepartment of Psychology, University of Alabama, Tuscaloosa, AL, USA.
Caitlin TrabertPrivate practice, Ebensburg, PA, USA.
Niza Tonarely-BustoDepartment of Psychology, University of Miami, Coral Gables, FL, USA.
Ashley M ShawSchool of Social and Behavioral Sciences, University of New England, Portland, ME, USA.
Flor de Abril CameronDepartment of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
David J KolkoDepartment of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.
Chaeryon KangDepartment of Psychiatry, Department of Biostatistics and Health Data, University of Pittsburgh, Pittsburgh, PA, USA.
Jill Ehrenreich-MayDepartment of Psychology, University of Miami, Coral Gables, FL, USA.
Todd J FarchioneDepartment of Psychological and Brain Sciences, Boston University, Boston, MA, USA.
Susan W WhiteDepartment of Psychology, University of Alabama, Tuscaloosa, AL, USA.

Funding

Patient-Centered Outcomes Research Institute IDD-2022C1-26418
6 · The paper itself

Abstract

backgroundMany autistic people seek therapy for mental health concerns or to improve emotional wellbeing. Unfortunately, there is limited guidance for providers on the most effective approach to improve mental health for autistic people. Therapies that target emotion dysregulation may be clinically effective and parsimonious. However, it remains unclear if emotion dysregulation interventions that were not developed for autism are effective or if interventions developed for autistic clients may confer additional benefits in terms of effectiveness and ease of implementation by community clinicians. The Emotion Awareness and Skills Enhancement (EASE) Program was developed to target emotion dysregulation specifically in autism, and has been shown to be efficacious for autistic youth and young adults in a standard clinical trial conducted in a research setting.

methodsIn this Hybrid Type 1 comparative effectiveness randomized controlled trial, we examine clinical impact and implementation outcomes across two treatments. The target intervention is a mindfulness-based curriculum developed for autistic clients (EASE) compared to the child, adolescent, and adult Unified Protocols (UP), established interventions rooted in cognitive-behavioral therapy that were not developed for autistic clients. This research is based on a community-driven, advisory model, including two community partner groups that provide input on project implementation. Providers are community clinicians at mental health agencies in Pennsylvania and Alabama, with randomization by agency. Clients include autistic individuals aged 10 to 30 years, with a target sample size of 400. Data are collected at pre-, mid-, post-, and 3 months following therapy. The primary aim is to test comparative effectiveness. The secondary aim is to evaluate the feasibility, benefits, harms, and implementation outcomes. A third exploratory aim focuses on moderators of outcome. EASE is hypothesized to outperform UP. The primary outcomes are client emotion dysregulation and provider-rated acceptability and feasibility of implementation. Secondary outcomes include responder status determined by a condition-naive interviewer, questionnaires of mental health, quality of life, and client satisfaction, and coder-rated therapeutic alliance. Qualitative data on feasibility and implementation outcomes is collected from clients, providers, and agency leaders. DISCUSSION: Findings will inform clinical decision-making and hopefully help increase access to evidence-based mental healthcare for autistic individuals.

trial registrationThis trial is registered with ClinicalTrials.gov ID NCT06158581. It was first registered on 11/27/23.

Indexed as

Affective SymptomsAutistic DisorderAwarenessCognitive Behavioral TherapyEmotional RegulationMindfulnessAdolescentAdultChildComparative Effectiveness ResearchFemaleHumansMaleRandomized Controlled Trials as TopicYoung AdultAutism spectrum disorderCognitive-behavioralComparative effectivenessEmotion dysregulationMental healthMindfulnessTherapy

Identifiers

PMID41514468
PMCPMC12882242

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.