Comparing Two Different Emotion Therapies for Autistic Youth and Young Adults
- Conditions
- Autism Spectrum Disorder
- Registration Number
- NCT06158581
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 470
- 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.
- Higher level of care is needed (Imminent Suicide / Homicide Threat, acute psychosis, mania)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Provider Self-Efficacy Scale 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.
Emotion Dysregulation Inventory 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 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.
- Secondary Outcome Measures
Name Time Method PROMIS Depression Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment It is a brief, change sensitive 8 item measure. It is a 1-5 scale, where 1 is Never and 5 is Always.
Child & Adolescent Mindfulness Measure Baseline, Midpoint (after completing 8 sessions), Post treatment (after all 16 sessions, average 16-20 weeks) 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.
WHO Quality of Life-BREF-ID Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment 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.
Buss-Perry Aggression Questionnaire Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment 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.
Satisfaction with Life Scale Baseline, Post treatment (after all 16 sessions, average 16-20 weeks) 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.
Credibility and Expectancy Questionnaire Baseline, Post treatment (after all 16 sessions, average 16-20 weeks) It will assess treatment expectancy and rationale for the assessed treatments.
Inventory of Statements about Self-Injury Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment 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.
Working Alliance Inventory Midpoint (after completing 8 sessions, average 8 weeks), After completing 15 sessions (average 15-19 weeks) 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.
Clinical Global Impressions Baseline, Post treatment (after all 16 sessions, average 16-20 weeks) 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.
PROMIS Anxiety Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment It is a brief, change sensitive 8 item measure. It is a 1-5 scale, where 1 is Never and 5 is Always.
Emotion Regulation Questionnaire for Children and Adolescents Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment 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.
Self-Compassion Scale-Youth Version Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment 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.
AASPIRE Patient Health Questionnaire-9 Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment 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.
AASPIRE Flourishing Scale Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment It is 9 item scale that assesses aspects of life satisfaction for autistic individuals. It is a scale from strongly disagree to strongly agree.
AASPIRE Burnout Scale Short Form Baseline, Post treatment (after all 16 sessions, average 16-20 weeks), 3 months following post-treatment It is a 14-item self-report measure of autistic burnout. It is a scale from strongly disagree to strongly agree.
Vanderbilt Therapeutic Alliance Scales Revised, Short Form 2 randomized timepoints over up to 20 Weeks 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 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).
Child Involvement Rating Scale 2 randomized timepoints over up to 20 Weeks 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 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).
Relationships, Employment, Autonomy, and Life Satisfaction Baseline, Post treatment (after all 16 sessions, average 16-20 weeks) 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.
Trial Locations
- Locations (2)
University of Alabama
🇺🇸Tuscaloosa, Alabama, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama🇺🇸Tuscaloosa, Alabama, United StatesMadison BradleyContact205-348-2472emotiontherapy@ua.edu