Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 4:36 AM
Study NCT ID:
NCT00179894
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavior changes as rated by teachers', 'timeFrame': 'Measured at Month 12'}], 'secondaryOutcomes': [{'measure': 'Behavior change as rated by parents', 'timeFrame': 'Measured at Month 12'}, {'measure': 'Behavior changes as rated by classroom observation', 'timeFrame': 'Measured at Month 12'}, {'measure': 'Relation between adherence to protocol and behavior change', 'timeFrame': 'Measured at Month 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD', 'Attention Deficit Hyperactivity Disorder'], 'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'descriptionModule': {'briefSummary': "This study will determine the effectiveness of educating pediatricians about attention deficit hyperactivity disorder treatment guidelines in improving child behavior and pediatricians' adherence to medication guidelines.", 'detailedDescription': 'The most effective treatment for improving the core symptoms of inattention, impulsivity and hyperactivity in children with attention deficit hyperactivity disorder (ADHD) involves the use of stimulant medications. Most children with ADHD are treated by pediatricians, but the treatment provided is often less than optimal. This study is designed to see if training for pediatricians in following guidelines for management of first-line medicines for ADHD leads to improvement in child behavior, and whether the physicians can adhere to the guidelines.\n\nOver 100 studies have shown that stimulant medications are effective for improving the core symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Approximately 70% of children who receive ADHD medications are treated by their primary care pediatrician, but studies show that management is not always optimal. The present study is designed to see if child behavior can be improved by training pediatricians in the use of guidelines for treating ADHD, and whether the physicians can adhere to the guidelines. Twenty-four pediatric practices were randomized to a treatment as usual or specialized care (receiving training in guidelines and computer assisted monitoring of patient progress and medication titration). Children are assessed with parent and teacher reports at baseline, 4-, 9-, and 12-months post initiation of treatment, and classroom observations of behavior are assessed at baseline, 6-, and 12-months. Approximately 400 children are to be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of ADHD\n* Not currently on medication\n\nExclusion Criteria:\n\n* No serious neurological disorders of sever mental health problems (suicidal behavior, autism)'}, 'identificationModule': {'nctId': 'NCT00179894', 'briefTitle': 'Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Improving Medication Use for ADHD in Primary Care', 'orgStudyIdInfo': {'id': 'R01MH066866', 'link': 'https://reporter.nih.gov/quickSearch/R01MH066866', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH066866', 'link': 'https://reporter.nih.gov/quickSearch/R01MH066866', 'type': 'NIH'}, {'id': 'DSIR 82-SECH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Physician training', 'description': 'Physician participants will receive training in guidelines and medication monitoring', 'interventionNames': ['Behavioral: Physician training']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Physician participants will provide usual care and no special intervention'}], 'interventions': [{'name': 'Physician training', 'type': 'BEHAVIORAL', 'description': 'Physicians are trained in guidelines for medication management.', 'armGroupLabels': ['1 Physician training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'John V. Lavigne, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Psychologist', 'investigatorFullName': 'John V. Lavigne', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}