Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 6:14 PM
Study NCT ID:
NCT00078728
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2004-03-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Family-Based Prevention Program for Childhood Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gginnsbu@jhmi.edu', 'phone': '410-955-1544', 'title': 'Golda Ginsburg, PhD,Professor', 'organization': 'The Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Of the 40 participants in the study, no adverse events occured or were reported.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 Family-based Prevention Program', 'description': 'Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Evaluation Only', 'description': 'Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Children With Child Anxiety Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Family-based Prevention Program', 'description': 'Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.'}, {'id': 'OG001', 'title': '2 Evaluation Only', 'description': 'Evaluation only : Participants will undergo evaluations without active intervention for 8 weeks but received an informational packet on anxiety disorders.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 month', 'description': 'Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Child Anxiety Diagnoses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1 Family-based Prevention Program', 'description': 'Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.'}, {'id': 'OG001', 'title': '2 Evaluation Only', 'description': 'Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Family-based Prevention Program', 'description': 'Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.'}, {'id': 'FG001', 'title': '2 Evaluation Only', 'description': 'Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '1 Family-based Prevention Program', 'description': 'Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.'}, {'id': 'BG001', 'title': '2 Evaluation Only', 'description': 'Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.20', 'spread': '1.91', 'groupId': 'BG000'}, {'value': '8.68', 'spread': '1.81', 'groupId': 'BG001'}, {'value': '8.94', 'spread': '1.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2004-03-05', 'resultsFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2004-03-05', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-24', 'studyFirstPostDateStruct': {'date': '2004-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Children With Child Anxiety Diagnosis', 'timeFrame': '12 month', 'description': 'Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.'}, {'measure': 'Child Anxiety Diagnoses', 'timeFrame': '12 months', 'description': 'The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anxiety'], 'conditions': ['Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.', 'detailedDescription': "Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care.\n\nParticipants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers with a current, primary anxiety disorder\n* 7-12 year old children without an anxiety disorder\n\nExclusion Criteria:\n\n* Mothers that do not have a current, primary anxiety disorder\n* 7-12 year old children with an anxiety disorder\n* 7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study'}, 'identificationModule': {'nctId': 'NCT00078728', 'briefTitle': 'Family-Based Prevention Program for Childhood Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Family-Based Prevention for Childhood Anxiety', 'orgStudyIdInfo': {'id': 'K23MH063427', 'link': 'https://reporter.nih.gov/quickSearch/K23MH063427', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23MH063427', 'link': 'https://reporter.nih.gov/quickSearch/K23MH063427', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Family-based anxiety prevention program', 'description': 'Participants will complete an 8 session (1 session/week), cognitive behavioral therapy-based, family prevention program to be administered by a trained clinician, after randomization to the study. The prevention program will include 3 booster sessions that take place after the first 8 sessions.', 'interventionNames': ['Behavioral: Family-Based Anxiety Prevention Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Evaluation only', 'description': 'Waitlist control group. Participants in this group will receive general information (in the form of a printed packet) about anxiety after randomization to the study. Families in this group will complete all study evaluations and will then be offered the option of participating in the prevention program. Families who accept will begin the prevention sessions and will receive the same CBT-based, family-based prevention program as the other treatment arm.', 'interventionNames': ['Behavioral: Evaluation only']}], 'interventions': [{'name': 'Family-Based Anxiety Prevention Program', 'type': 'BEHAVIORAL', 'description': 'Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. The intervention will begin immediately after randomization to the study.', 'armGroupLabels': ['Family-based anxiety prevention program']}, {'name': 'Evaluation only', 'type': 'BEHAVIORAL', 'description': 'Participants will undergo evaluations without active treatment for 8 weeks.', 'armGroupLabels': ['Evaluation only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Golda S. Ginsburg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}