Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT01487967
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2011-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of family recruitment and follow-up', 'timeFrame': 'Up to 24 months', 'description': 'The feasibility of this intervention will be assessed by examining the proportion of families screened that meet enrollment criteria, the proportion meeting enrollment criteria that enroll, and the proportion enrolled that complete each study measure.'}], 'secondaryOutcomes': [{'measure': 'Joint Participation in Decision-Making and Partnership', 'timeFrame': 'Baseline', 'description': 'Participation in decision-making, measured by the Observing Patient Involvement (OPTION) scale.\n\nPatient partnership, measured by the Patient Participation in Care Scale score after the initial visit at which ADHD treatment decisions are made'}, {'measure': 'Treatment Acceptability', 'timeFrame': 'Baseline, after 3 months, after 6 months', 'description': 'Treatment acceptability measured by the Treatment Acceptability Questionnaire, Parent version (TAQ-P).'}, {'measure': 'Parent Engagement', 'timeFrame': 'Up to 24 months', 'description': 'Engagement will be measured by the number of primary care visits and number of primary care phone calls over the course of the study period'}, {'measure': 'Treatment Adherence/Receipt', 'timeFrame': 'Up to 24 months', 'description': 'Treatment adherence/receipt measured by the number of mental health visits, number of medication refills, and length of time taken to reach a stable treatment dose.'}, {'measure': 'Clinical Outcomes', 'timeFrame': 'Baseline, after 3 months, after 6 months', 'description': 'Change in symptom severity, measured by the Vanderbilt scale over time Change in functional impairment, measured by the Columbia Impairment Scale (CIS), over time'}, {'measure': 'Goal Attainment', 'timeFrame': 'after 3 months, after 6 months', 'description': 'Parents will identify goals at the study start, and progress toward meeting those goals will be tracked during the study.'}, {'measure': 'Acceptability of the intervention to parents and clinicians', 'timeFrame': 'Up to 24 months', 'description': 'Satisfaction with the intervention will be assessed by parent and clinician responses to open-ended questions about satisfaction, acceptability and unintended consequences of the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attention Deficit Hyperactivity Disorder', 'ADHD', 'Preferences', 'Goals', 'Decision Making'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': "This pilot intervention study will test the feasibility and acceptability and explore the outcomes of an urban, primary care-based intervention to measure families' preferences and goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical care to reach these goals.", 'detailedDescription': 'The intervention includes provision of enhanced, culturally appropriate education about ADHD and its treatment, completion of a validated preference and goal instrument, use of this instrument in the ADHD treatment decision-making process, and tracking of preferences and goals over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All interested non-trainee clinicians at study sites\n* Parents/legal guardians of children age 6-12, in K-6 grade, diagnosed with ADHD.\n\nExclusion Criteria:\n\n* child diagnosed with autism or a psychotic disorder\n* parents non-English speaking\n* parents unable to provide consent\n* pediatric residents'}, 'identificationModule': {'nctId': 'NCT01487967', 'briefTitle': 'Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Preference and Goal-Directed Primary Care to Minimize Disparities and Improve Outcomes in ADHD', 'orgStudyIdInfo': {'id': '11-008315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Families in the intervention arm will receive culturally appropriate educational material, complete the Preference and Goal Instrument at the study start, use the results to inform decision making about ADHD treatment, have their preferences/goals tracked in the electronic health record, and have their progress toward their goals assessed at 3 months and 6 months (approximately).', 'interventionNames': ['Other: Preference and Goal Instrument']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Parents will receive education on ADHD and its treatment, and otherwise receive standard care.'}], 'interventions': [{'name': 'Preference and Goal Instrument', 'type': 'OTHER', 'description': 'Families in the intervention arm will receive culturally appropriate educational material, complete the Preference and Goal Instrument at the study start, use the results to inform decision making about ADHD treatment, have their preferences/goals tracked in the electronic health record, and have their progress toward their goals assessed at 3 months and 6 months (approximately).', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Alexander G Fiks, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}