Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT01591694
Status:
COMPLETED
Last Update Posted:
2018-04-06
First Post:
2012-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D019955', 'term': 'Conduct Disorder'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2012-04-09', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavior', 'timeFrame': '1 year', 'description': 'Improved behavioral and emotional regulation, i.e., improved behavior compliance, improved misbehavior symptoms, reduced symptoms of anxiety, depression, attention deficit hyperactivity disorder (ADHD), conduct disorder, oppositional defiant disorder, and post traumatic stress syndrome (PTSD). Improved sleep, toileting, parent-child attachment, and mood regulation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['child trauma', 'maltreatment', 'physical abuse', 'sexual abuse', 'emotional abuse', 'abandonment', 'domestic violence', 'community violence'], 'conditions': ['Post Traumatic Stress Disorder', 'Anxiety', 'Depression', 'Conduct Disorder', 'ADHD']}, 'descriptionModule': {'briefSummary': 'Trauma-informed treatment will improve emotional regulation and behavior.', 'detailedDescription': "The proposed study is to request permission to continue federally mandated data collection to examine the clinical outcomes of children at the Family Center at Kennedy Krieger Institute who are enrolled in evidence-based and promising trauma-informed treatments as part of the National Child Traumatic Stress Network funded by the Substance Abuse and Mental Health Services Administration. The purpose of the National Child Traumatic Stress Initiative(NCTSNI) Evaluation is to determine the extent to which the NCTSI, through the National Child Traumatic Stress Network (NCTSN), has raised the standard of care and improved access to services for traumatized children. In addition, the evaluation assesses the extent to which the NCTSI has served as a national resource capable of improving children's access to high-quality, trauma-informed mental health services. This data, previously collected and managed by the Category I NCTSN Center at Duke will now be managed by ICF Macro in a data system entitled NICON."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children enrolled in treatment at the Family Center and their caregivers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children enrolled in treatment at the Family Center and caregivers\n\nExclusion Criteria:\n\n* Psychosis,\n* Inability to comply with directions'}, 'identificationModule': {'nctId': 'NCT01591694', 'briefTitle': 'National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database', 'organization': {'class': 'OTHER', 'fullName': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}, 'officialTitle': 'National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database', 'orgStudyIdInfo': {'id': 'NA_00047384'}, 'secondaryIdInfos': [{'id': '2U79SM056215', 'link': 'https://reporter.nih.gov/quickSearch/2U79SM056215', 'type': 'SAMHSA'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'FamilyLive', 'description': 'Families with a history of intergenerational trauma (maltreatment, violence exposure, domestic violence, substance abuse, etc.)'}, {'label': 'Yoga Based Psychotherapy', 'description': 'Children with a history of maltreatment and/or violence exposure'}, {'label': 'Biofeedback', 'description': 'Children with a history of maltreatment and violence exposure and their caregivers'}, {'label': 'TST-SA', 'description': 'Trauma Systems Therapy for Adolescent Substance Abuse'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Family Center at Kennedy Krieger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Harolyn Belcher, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Kennedy Krieger Family Center; Associate Professor, Johns Hopkins University School of Medicine.', 'investigatorFullName': 'Harolyn M.E.Belcher, M.D.', 'investigatorAffiliation': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}}}}