Autism Spectrum DisorderNCT06158581
Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults
A study testing The Emotion Awareness and Skills Enhancement Program and The Unified Protocol in people with Autism Spectrum Disorder, run by University of Pittsburgh at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- The Emotion Awareness and Skills Enhancement Program and The Unified Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Higher level of care is needed (Imminent Suicide / Homicide Threat, acute psychosis, mania)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Kara L Duman, MSW, 1-866-647-3436, emotiontherapy@upmc.edu
- Recruiting
University of Alabama
Tuscaloosa, Alabama, 35401
Madison Bradley, 205-348-2472, emotiontherapy@ua.edu
About this study
Official title: The Emotion Awareness and Skills Enhancement (EASE) Program Versus the Unified Protocol (UP)
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- The Emotion Awareness and Skills Enhancement Program, The Unified Protocol
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Emotion Awareness and Skills Enhancement ProgramBehavioural
Also called EASE
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 ProtocolBehavioural
Also called UP
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.
| Study group | Role | What they receive |
|---|---|---|
| The Emotion Awareness and Skills Enhancement | Experimental | 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. Receives: Behavioral: The Emotion Awareness and Skills Enhancement Program |
| The Unified Protocol | Active comparator | 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. Receives: Behavioral: The Unified Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline and Post treatment of first client (after all 16 sessions, average 16-20 weeks)
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.
Measured: Baseline and Post trial (4 years)
Secondary outcomes (18)
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks)
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Credibility and Expectancy Questionnaire
It will assess treatment expectancy and rationale for the assessed treatments.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
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.
Measured: Midpoint (after completing 8 sessions, average 8 weeks), After completing 15 sessions (average 15-19 weeks)
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 or audio files 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).
Measured: 2 randomized timepoints over up to 20 Weeks
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 or audio files 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).
Measured: 2 randomized timepoints over up to 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start8 Apr 2024
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama, Tuscaloosa, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Carla Mazefsky, University of Pittsburgh
- Investigators
- Carla Mazefsky, PhD, Principal investigator, University of PittsburghSusan White, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158581
- Sponsor's protocol ID
- STUDY23090024
- Other IDs
- IDD-2022C1-26418
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PCORI, the funder, is committed to open science and the investigators are required to deposit their Full Data package in a PCORI-designated data repository. The investigators will enter into a Data Contributor Agreement with a PCORI-designated repository after the investigators complete data collection. The repository will make the Full Data Package available for third-party requests when PCORI makes the Final Research Report available on the PCORI website, or at the time of publication of the research project's primary results in a peer-reviewed journal, whichever comes first.
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.
PubMed 30400749Ellard 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.
PubMed 33762811Barlow 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 with emotion dysregulation. BMC Psychol. 2026 Jan 9;14(1):187. doi: 10.1186/s40359-025-03891-7.
PubMed 41514468
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emotion Awareness and Skills Enhancement (EASE) Program Versus the Unified Protocol (UP)
- ClinicalTrials.gov ID
- NCT06158581
- Acronym / sponsor ID
- STUDY23090024
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Alabama, Tuscaloosa, Patient-Centered Outcomes Research Institute
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Emotion Awareness and Skills Enhancement | Experimental | Behavioral: The Emotion Awareness and Skills Enhancement ProgramEASE 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. |
| The Unified Protocol | Active comparator | Behavioral: The Unified ProtocolUP 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. |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Higher level of care is needed (Imminent Suicide / Homicide Threat, acute psychosis, mania)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Emotion Awareness and Skills Enhancement ProgramAlso: EASEEASE 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. | Behavioural | The Emotion Awareness and Skills Enhancement |
| The Unified ProtocolAlso: UPUP 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. | Behavioural | The Unified Protocol |
Primary outcome
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
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.
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)
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.
Provider Self-Efficacy Scale
Time frame: Baseline and Post trial (4 years)
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.
18 secondary outcomes
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
Credibility and Expectancy Questionnaire
Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks)
AASPIRE Patient Health Questionnaire-9
Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Inventory of Statements about Self-Injury
Time frame: Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment
Working Alliance Inventory
Time frame: Midpoint (after completing 8 sessions, average 8 weeks), After completing 15 sessions (average 15-19 weeks)
Vanderbilt Therapeutic Alliance Scales Revised, Short Form
Time frame: 2 randomized timepoints over up to 20 Weeks
Child Involvement Rating Scale
Time frame: 2 randomized timepoints over up to 20 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 30400749Conner 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.
- Background: PubMed 33762811Ellard 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.
- BackgroundBarlow 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.
- BackgroundEhrenreich-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.
- Derived from this study: PubMed 41514468Mazefsky 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 with emotion dysregulation. BMC Psychol. 2026 Jan 9;14(1):187. doi: 10.1186/s40359-025-03891-7.
- Individual participant dataSharing planned: Yes. PCORI, the funder, is committed to open science and the investigators are required to deposit their Full Data package in a PCORI-designated data repository. The investigators will enter into a Data Contributor Agreement with a PCORI-designated repository after the investigators complete data collection. The repository will make the Full Data Package available for third-party requests when PCORI makes the Final Research Report available on the PCORI website, or at the time of publication of the research project's primary results in a peer-reviewed journal, whichever comes first.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carla Mazefsky, PhD principal investigator
University of Pittsburgh
Susan White, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Emotion Awareness and Skills Enhancement Program and The Unified Protocol in people with Autism Spectrum Disorder, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara Duman, MSW (1-866-647-3436, emotiontherapy@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158581, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.