Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT03432832
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2018-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emotion Awareness and Skills Enhancement Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-08', 'size': 1280213, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-09T12:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'per protocol analysis versus intent to treat analytic approach due to the pandemic'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2018-01-17', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Clinical Global Impression Scale- Improvement (CGI-I)', 'timeFrame': 'The CGI-I will be completed at 16 weeks (post-treatment)', 'description': 'The CGI-I will be used as a measure of overall improvement. The CGI-I (Improvement) scale 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.'}, {'measure': 'Emotion Dysregulation Inventory Reactivity Scale Short Form (EDI-SF)', 'timeFrame': 'The EDI-SF will be completed at 16 weeks (post-treatment).', 'description': 'The EDI SF is a measure of emotional reactivity and regulation. The EDI SF is based on theta scores, with a mean of 0 and SD of 1 and possible range from -1.99 to 2.105. Higher scores suggest greater dysregulation, so improvement would be measured by a decrease in scores.'}], 'secondaryOutcomes': [{'measure': 'Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': 'The CGI-I will be completed at 16 weeks (post-treatment)', 'description': 'The Brief Psychiatric Rating Scale (BPRS) is an interview-based measure of psychopathology severity widely used in clinical trials. It consists of 24 items that measure psychiatric symptoms, each of which are on a 1 (not reported) to 7 (very severe) scale, so that lower scores are an indication of improvement. An assignment naïve rater scores the items based upon client report and clinical observation. All scales ask about symptoms over the last 7 days. The single item on "Global Improvement" will be used.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Abidin, R. R. (2012). Parenting Stress Index, Fourth Edition Short Form (PSI-4). Lutz, FL: PAR.'}, {'type': 'BACKGROUND', 'citation': 'Achenbach, T. M., & Rescorla, L. (2001). Manual for the ASEBA school-age forms and profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.'}, {'pmid': '20015584', 'type': 'BACKGROUND', 'citation': 'Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.'}, {'pmid': '3993694', 'type': 'BACKGROUND', 'citation': 'Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.'}, {'pmid': '26262903', 'type': 'BACKGROUND', 'citation': 'Aman M, Rettiganti M, Nagaraja HN, Hollway JA, McCracken J, McDougle CJ, Tierney E, Scahill L, Arnold LE, Hellings J, Posey DJ, Swiezy NB, Ghuman J, Grados M, Shah B, Vitiello B. Tolerability, Safety, and Benefits of Risperidone in Children and Adolescents with Autism: 21-Month Follow-up After 8-Week Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2015 Aug;25(6):482-93. doi: 10.1089/cap.2015.0005.'}, {'pmid': '25096930', 'type': 'BACKGROUND', 'citation': 'Anagnostou E, Jones N, Huerta M, Halladay AK, Wang P, Scahill L, Horrigan JP, Kasari C, Lord C, Choi D, Sullivan K, Dawson G. Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder. Autism. 2015 Jul;19(5):622-36. doi: 10.1177/1362361314542955. Epub 2014 Aug 5.'}, {'pmid': '24313878', 'type': 'BACKGROUND', 'citation': 'Anderson DK, Liang JW, Lord C. Predicting young adult outcome among more and less cognitively able individuals with autism spectrum disorders. J Child Psychol Psychiatry. 2014 May;55(5):485-94. doi: 10.1111/jcpp.12178. Epub 2013 Dec 9.'}, {'pmid': '10842426', 'type': 'BACKGROUND', 'citation': 'Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.'}, {'pmid': '17899349', 'type': 'BACKGROUND', 'citation': 'Baker AE, Lane A, Angley MT, Young RL. The relationship between sensory processing patterns and behavioural responsiveness in autistic disorder: a pilot study. J Autism Dev Disord. 2008 May;38(5):867-75. doi: 10.1007/s10803-007-0459-0.'}, {'pmid': '3806354', 'type': 'BACKGROUND', 'citation': 'Baron RM, Kenny DA. 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Epub 2014 Mar 7.'}, {'pmid': '27699685', 'type': 'BACKGROUND', 'citation': 'Mazefsky CA, Day TN, Siegel M, White SW, Yu L, Pilkonis PA; Autism and Developmental Disabilities Inpatient Research Collaborative (ADDIRC). Development of the Emotion Dysregulation Inventory: A PROMIS(R)ing Method for Creating Sensitive and Unbiased Questionnaires for Autism Spectrum Disorder. J Autism Dev Disord. 2018 Nov;48(11):3736-3746. doi: 10.1007/s10803-016-2907-1.'}, {'pmid': '24231164', 'type': 'BACKGROUND', 'citation': 'Mazefsky CA, White SW. Emotion regulation: concepts & practice in autism spectrum disorder. Child Adolesc Psychiatr Clin N Am. 2014 Jan;23(1):15-24. doi: 10.1016/j.chc.2013.07.002. Epub 2013 Aug 30.'}, {'pmid': '12151468', 'type': 'BACKGROUND', 'citation': 'McCracken JT, McGough J, Shah B, Cronin P, Hong D, Aman MG, Arnold LE, Lindsay R, Nash P, Hollway J, McDougle CJ, Posey D, Swiezy N, Kohn A, Scahill L, Martin A, Koenig K, Volkmar F, Carroll D, Lancor A, Tierney E, Ghuman J, Gonzalez NM, Grados M, Vitiello B, Ritz L, Davies M, Robinson J, McMahon D; Research Units on Pediatric Psychopharmacology Autism Network. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002 Aug 1;347(5):314-21. doi: 10.1056/NEJMoa013171.'}, {'pmid': '20483969', 'type': 'BACKGROUND', 'citation': 'Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S, Walkup JT. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010 May 19;303(19):1929-37. doi: 10.1001/jama.2010.607.'}, {'pmid': '24951836', 'type': 'BACKGROUND', 'citation': 'Rieffe C, De Bruine M, De Rooij M, Stockmann L. Approach and avoidant emotion regulation prevent depressive symptoms in children with an Autism Spectrum Disorder. Int J Dev Neurosci. 2014 Dec;39:37-43. doi: 10.1016/j.ijdevneu.2014.06.003. Epub 2014 Jun 19.'}, {'pmid': '26371618', 'type': 'BACKGROUND', 'citation': 'Shallcross AJ, Gross JJ, Visvanathan PD, Kumar N, Palfrey A, Ford BQ, Dimidjian S, Shirk S, Holm-Denoma J, Goode KM, Cox E, Chaplin W, Mauss IB. Relapse prevention in major depressive disorder: Mindfulness-based cognitive therapy versus an active control condition. J Consult Clin Psychol. 2015 Oct;83(5):964-75. doi: 10.1037/ccp0000050. Epub 2015 Aug 10.'}, {'pmid': '18645422', 'type': 'BACKGROUND', 'citation': 'Simonoff E, Pickles A, Charman T, Chandler S, Loucas T, Baird G. 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J Autism Dev Disord. 2015 Dec;45(12):3939-48. doi: 10.1007/s10803-015-2592-5.'}, {'pmid': '20091348', 'type': 'BACKGROUND', 'citation': 'White SW, Albano AM, Johnson CR, Kasari C, Ollendick T, Klin A, Oswald D, Scahill L. Development of a cognitive-behavioral intervention program to treat anxiety and social deficits in teens with high-functioning autism. Clin Child Fam Psychol Rev. 2010 Mar;13(1):77-90. doi: 10.1007/s10567-009-0062-3.'}, {'pmid': '22735897', 'type': 'BACKGROUND', 'citation': 'White SW, Ollendick T, Albano AM, Oswald D, Johnson C, Southam-Gerow MA, Kim I, Scahill L. Randomized controlled trial: Multimodal Anxiety and Social Skill Intervention for adolescents with autism spectrum disorder. J Autism Dev Disord. 2013 Feb;43(2):382-94. doi: 10.1007/s10803-012-1577-x.'}, {'pmid': '27262124', 'type': 'BACKGROUND', 'citation': 'White SW, Elias R, Salinas CE, Capriola N, Conner CM, Asselin SB, Miyazaki Y, Mazefsky CA, Howlin P, Getzel EE. Students with autism spectrum disorder in college: Results from a preliminary mixed methods needs analysis. Res Dev Disabil. 2016 Sep;56:29-40. doi: 10.1016/j.ridd.2016.05.010. Epub 2016 Jun 1.'}, {'pmid': '28685409', 'type': 'BACKGROUND', 'citation': 'White SW, Elias R, Capriola-Hall NN, Smith IC, Conner CM, Asselin SB, Howlin P, Getzel EE, Mazefsky CA. Development of a College Transition and Support Program for Students with Autism Spectrum Disorder. J Autism Dev Disord. 2017 Oct;47(10):3072-3078. doi: 10.1007/s10803-017-3236-8.'}, {'pmid': '40750084', 'type': 'DERIVED', 'citation': 'White SW, Conner CM, Beck K, Mazefsky CA. Efficacy of the Emotion Awareness and Skills Enhancement (EASE) Program in Autism: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Jul 31:S0890-8567(25)01410-8. doi: 10.1016/j.jaac.2025.07.1058. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This project will address impaired emotion regulation in adolescents with ASD (autism spectrum disorder). There are no evidence-based interventions to improve emotion regulation (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and substantially impedes capacity to learn and function across all life settings, and reduce their quality of life and that of their families. The primary objective of this study is to formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled trial (RCT).', 'detailedDescription': "The current study is to test a new intervention called Emotional Awareness and Skills Enhancement (EASE). This program was designed to address ASD-specific obstacles to effective emotion regulation, such as reduced awareness concerning others' intentions, a limited repertoire of behavioral responses, and inadequate language for understanding emotional experiences. This new program is based on an acceptance-based approach in which awareness of emotion is developed, emotions (whether negative or positive) are accepted, and behavior is regulated in the face of intense emotion. The goal is not to learn to avoid negative emotions, but rather to develop a collection of abilities which allow the individual to manage stress and act in ways that are more adaptive. The investigators expect to find that participants' emotion dysregulation will decrease and their adaptive function will increase following completion of the EASE program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ages 12-21 years, inclusive\n2. A diagnosis of ASD (autism spectrum disorder), as defined by exceeding the ASD cutoff on the ADOS-2 (Autism Diagnostic Observation Scale) or ADI-R (Autism Diagnostic Interview-Revised) In. If the participant has completed the ADOS in a previous study within 3 years and signs a release of information to obtain it, they will not be required to complete another ADOS.\n3. Average verbal intellectual ability (Wechsler Abbreviated Scale of Intelligence-2 \\[WASI-2\\] FSIQ \\>=75).\n4. Fluent in the English language\n5. Problems with regulating emotions based on parent report 6) Parent/guardian who will attend sessions and assessments.\n\nExclusion Criteria:\n\n1. Current concerns of suicidality that warrants immediate clinical care (such potential participants will be referred elsewhere for treatment), determined by clinical interview.\n2. Previous or current diagnosis of a psychotic disorder.\n3. Receiving concurrent psychotherapy treatment for emotional issues (i.e., depression, anxiety, anger) that overlaps with the current study. This will be assessed using current treatment items on the demographic forms.'}, 'identificationModule': {'nctId': 'NCT03432832', 'acronym': 'EASE', 'briefTitle': 'Emotion Awareness and Skills Enhancement Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Emotion Awareness and Skills Enhancement (EASE) Program: A Clinical Trial', 'orgStudyIdInfo': {'id': 'STUDY20110317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotion Awareness/Skills Enhancement', 'description': 'EASE Therapy includes 16 weekly sessions focused on mindfulness exercise, review of prior content, practicing prior skills, outline of current session, discussion of the new skill, handouts, practice and plan for out of session practice held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The investigators will apply a multimodal teaching approach, where individual therapy is buttressed by parent involvement and practice sessions in the youth\'s community. A secure website developed for this project (emotion-Coach or "e-Coach") will augment the intervention by providing online supports to increase treatment intensity or dosage. There will be specific information on how to reinforce the skills at home and in the community.', 'interventionNames': ['Behavioral: EASE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supportive Therapy', 'description': "Supportive Therapy will involve attending 16 weekly therapy sessions held in Webster Hall in Pittsburgh, at the Center for the Prevention of Youth Behavior Problems in Tuscaloosa or via telehealth conferencing software. The intervention will not involve mindfulness or other emotion regulation strategies used in EASE. The therapy will be tailored to the individual's needs and will include aspects common in supportive therapy such as reflective listening, antecedent management, and problem-solving. This program does not have an online component.", 'interventionNames': ['Behavioral: Supportive Therapy']}], 'interventions': [{'name': 'EASE', 'type': 'BEHAVIORAL', 'description': 'Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.', 'armGroupLabels': ['Emotion Awareness/Skills Enhancement']}, {'name': 'Supportive Therapy', 'type': 'BEHAVIORAL', 'description': 'Weekly behavioral sessions with a therapist to work on emotional control', 'armGroupLabels': ['Supportive Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35487', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Shannondora Porton', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Carla Mazefsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Susan White', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Carla Mazefsky', 'investigatorAffiliation': 'University of Pittsburgh'}}}}