Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-05 @ 9:55 PM
Study NCT ID:
NCT00536094
Status:
COMPLETED
Last Update Posted:
2013-09-24
First Post:
2007-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
School-based Treatment for Anxious Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-23', 'studyFirstSubmitDate': '2007-09-25', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety Disorders Interview Schedule for DSM-IV: Child Version', 'timeFrame': 'Measured at pre-treatment, post-treatment, and one month follow-up'}], 'secondaryOutcomes': [{'measure': 'Screen for Child Anxiety Related Disorders (SCARED) - Child Version', 'timeFrame': 'Measured at pre-treatment, post-treatment, and one month follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cognitive behavioral therapy', 'Youth', 'School', 'African American'], 'conditions': ['Anxiety Disorders']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ginsburg, G. S., Becker, K. D., Kingery, J.,and Nichols, T. (2008). Transporting CBT for childhood anxiety disorders into inner city school-based mental health clinics. Cognitive and Behavioral Practice, 15, 148-158.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of a school-based cognitive behavior therapy in urban, predominantly low-income, African-American children diagnosed with an anxiety disorder.', 'detailedDescription': 'Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal part of life and growing up, for some children this anxiety becomes chronic, relentless, and progressively worse if left untreated. Physical symptoms typically accompany the intense anxiety caused by the disorder and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Anxiety disorders among children have become increasingly prevalent, indicating that excessive fear, worry, and anxiety in children are emerging public health issues. Recent studies have shown that CBT is an effective form of treatment for childhood anxiety disorders; however, it often requires the use of expert CBT clinicians. The purpose of this study is to deliver a school-based version of CBT to predominantly low-income, inner-city, African-American children with anxiety disorders. Clinicians within the school will undergo CBT training and adapt the treatment program to fit the needs of the participating children.\n\nAll participants in this study will undergo an initial evaluation to assess anxiety symptoms, disorders, and associated impairments. The children will then be randomly assigned to receive 12 weekly sessions of school-based CBT or treatment as usual, which will involve 12 weekly sessions of psychosocial treatment. Three parent sessions will be offered for families in both groups at Weeks 2, 6, and 10. All treatment sessions will occur at school during the day and will be led by school-based clinicians. A follow-up session will be conducted at post-treatment and 1 month after the last session to assess anxiety symptoms and disorders. Parent, teacher, and clinician ratings will also be used to assess the treatment outcomes of each child.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets DSM-IV criteria for primary diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), specific phobia (SP), or social phobia (SOP)\n* Received a score of at least 4 on the ADIS for DSM-IV:C's Clinician's Severity Rating Scale (CSR) for GAD, SAD, SP, and/or SOP\n* Received a minimum 1 point difference in ADIS for DSM-IV:C severity scores between the primary disorder and other disorders (e.g., depressive disorders, disruptive behavior disorders, attention deficit hyperactive disorder \\[ADHD\\], and other anxiety disorders such as obsessive compulsive disorder \\[OCD\\], post-traumatic stress disorder \\[PTSD\\], acute stress disorder)\n\nExclusion Criteria:\n\n* Diagnosed with a pervasive developmental disorder, mental retardation, organic mental disorders, schizophrenia, or other psychotic disorders\n* Psychotic or suicidal\n* Currently receiving treatment for anxiety\n* Requires immediate or alternative treatment\n* Previously failed a trial of at least 10 sessions for anxiety within 2 years of study entry\n* Absent 50% of school days in the 2 months preceding random assignment to treatment groups\n* History of child abuse and requires ongoing Department of Social Services supervision"}, 'identificationModule': {'nctId': 'NCT00536094', 'briefTitle': 'School-based Treatment for Anxious Children', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'School-Based CBT for Anxious African-American Children', 'orgStudyIdInfo': {'id': 'R34MH074552', 'link': 'https://reporter.nih.gov/quickSearch/R34MH074552', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R34MH074552', 'link': 'https://reporter.nih.gov/quickSearch/R34MH074552', 'type': 'NIH'}, {'id': 'DSIR 84-CTS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive cognitive behavioral therapy for anxiety that includes exposure', 'interventionNames': ['Behavioral: Cognitive behavioral therapy (CBT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will receive treatment as usual as delivered by school-based clinicians', 'interventionNames': ['Behavioral: Treatment as usual (TAU)']}], 'interventions': [{'name': 'Cognitive behavioral therapy (CBT)', 'type': 'BEHAVIORAL', 'otherNames': ['CBT'], 'description': 'CBT includes 45-minute psychotherapy sessions once a week for a period of approximately 12 weeks.', 'armGroupLabels': ['1']}, {'name': 'Treatment as usual (TAU)', 'type': 'BEHAVIORAL', 'otherNames': ['TAU'], 'description': 'TAU includes 45-minute psychosocial treatment sessions once a week for a period of approximately 12 weeks.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Golda Ginsburg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Golda S. Ginsburg, Ph.D.', 'investigatorAffiliation': 'National Institute of Mental Health (NIMH)'}}}}