Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-29 @ 7:01 PM
Study NCT ID:
NCT05777161
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2023-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-20', 'size': 847173, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-08T07:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors were blind to condition. The integrity of the blind was evaluated'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in functioning per parent', 'timeFrame': 'Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)', 'description': "Children's Sheehan Disability Scale (parent report) consisting of 5 items rated from 0 (not at all) to 10 (very, very much) summed to total score ranging from 0 (no interference) to 50 (severe interference)."}, {'measure': 'Change in functioning per child', 'timeFrame': 'Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)', 'description': "Children's Sheehan Disability Scale (child report) consisting of 3 items rated from 0 (not at all) to 10 (very, very much) summed to total score ranging from 0 (no interference) to 30 (severe interference)."}], 'primaryOutcomes': [{'measure': 'Change in symptom severity per blinded independent evaluator', 'timeFrame': 'Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)', 'description': 'Measured by the Clinical Global Impression Scale (GCI-S) rating of severity of psychopathology ranging from 1 (not at all ill) to 7 (extremely ill), with a score of 1 or 2 reflecting no to minimal symptoms'}, {'measure': 'Treatment efficiency', 'timeFrame': 'post-treatment (approximately 14 weeks)', 'description': 'Number of appointments attended'}], 'secondaryOutcomes': [{'measure': 'Change in anxiety symptoms per blinded independent evaluator', 'timeFrame': 'Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)', 'description': 'Pediatric Anxiety Rating Scale consisting of 5 items rated from 0 (no symptoms) to 5 (most severe) summed for a total score ranging from 0 (no symptoms) to 25 (most severe).'}, {'measure': 'Change in symptom severity per parent', 'timeFrame': 'Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)', 'description': "Spence Children's Anxiety Scale parent-report consisting of 38 items rated from 0 (never) to 3 (always) summed to a total score of 0 (no symptoms) to 108 (most severe)."}, {'measure': 'Change in symptom severity per child', 'timeFrame': 'Baseline, mid-treatment (after 6 sessions), post-treatment (approximately 14 weeks)', 'description': "Spence Children's Anxiety Scale child-report consisting of 38 items rated from 0 (never) to 3 (always) summed to a total score of 0 (no symptoms) to 108 (most severe)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety Disorders', 'Obsessive-Compulsive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety disorders and obsessive compulsive disorder (OCD).', 'detailedDescription': 'The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) through baseline comparisons, to compare effectiveness of individual PCET and individual standard cognitive behavioral therapy (CBT), to compare efficiency of individual PCET and individual standard CBT, to compare effectiveness of group intensive PCET, individual PCET, and individual standard CBT, and acceptability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a DSM-5 anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, agoraphobia, separation anxiety disorder, social and specific phobias, as assessed on the relevant modules of the (MINI-Kids; (Sheehan et al., 2010) by study staff in the PADC.\n* Be appropriate for the PADC standard outpatient therapy program, and be interested in starting outpatient therapy,\n* Have the anxiety disorder as their primary diagnosis,\n* If taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic medication, had no medication changes made at least 8 weeks prior to initiating participation in the study and agree to no changes during the 12 weeks of the study.\n\nExclusion Criteria:\n\n* History of and/or current psychosis, autism, bipolar disorder, or current suicidality, or eating disorder as assessed during the initial clinical interview and all available clinical information.\n* Current positive diagnosis in the child's caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives (based on clinical interview).\n* Secondary diagnosis of oppositional defiant disorder or major depression of sufficient severity to prevent anxiety treatment.\n* Severity of symptoms that warrant higher level of care (i.e. intensive, residential, IOP, inpatient)\n* Family is unable to attend weekly sessions (i.e. geographical or scheduling barriers)\n* History of good quality exposure or CBT."}, 'identificationModule': {'nctId': 'NCT05777161', 'briefTitle': 'A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Randomized-controlled Trial of Therapy for Children and Adolescents With Anxiety Disorders and Obsessive Compulsive Disorder (OCD)', 'orgStudyIdInfo': {'id': '20-008982'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parent Coached Exposure Therapy-Individual (PCET-I) Group', 'description': 'Subjects will receive six to 14 weekly sessions of individual Parent Coached Exposure Therapy', 'interventionNames': ['Behavioral: Parent Coached Exposure Therapy - Individualized']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Cognitive Behavior Therapy (CBT) Group', 'description': 'Subjects will receive 6 to 14 weekly sessions of individual Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Cognitive Behavior Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study)', 'description': 'Subjects will receive 5 day (nine sessions) of group-based Parent Coached Exposure Therapy delivered within a span of five days (Monday through Friday), followed by 5 weeks of self-care', 'interventionNames': ['Behavioral: Parent Coached Exposure Therapy - Group (removed from study)']}], 'interventions': [{'name': 'Parent Coached Exposure Therapy - Individualized', 'type': 'BEHAVIORAL', 'otherNames': ['PCET-I'], 'description': 'Subject and parent begin by working with a therapist to create an individualized fear hierarchy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety.', 'armGroupLabels': ['Parent Coached Exposure Therapy-Individual (PCET-I) Group']}, {'name': 'Cognitive Behavior Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.', 'armGroupLabels': ['Traditional Cognitive Behavior Therapy (CBT) Group']}, {'name': 'Parent Coached Exposure Therapy - Group (removed from study)', 'type': 'BEHAVIORAL', 'otherNames': ['PCET'], 'description': 'Subjects and parents will work in a group setting to receive exposure therapy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety.', 'armGroupLabels': ['Parent Coached Exposure Therapy-5day Intensive (PCET-5day) Group (removed from study)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Stephen Whiteside, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Following publication of results. Indefinitely by request.', 'ipdSharing': 'YES', 'description': 'Current upon request. Determining how to make data more easily accessible.', 'accessCriteria': 'Approval of analysis plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephen Whiteside', 'investigatorAffiliation': 'Mayo Clinic'}}}}