Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-25 @ 12:02 AM
Study NCT ID:
NCT02441569
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2015-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Common Engagement Strategies (Common Factors) for Childhood Anxiety
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-05', 'studyFirstSubmitDate': '2015-05-08', 'studyFirstSubmitQcDate': '2015-05-11', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Screen for Child Anxiety Related Emotional Disorders (SCARED)', 'timeFrame': '3 months', 'description': 'Re-test on short inventory of anxiety-related symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': "This trial examines the effectiveness of training pediatric primary care providers (nurse practitioners, doctors) to use of strategies that enhance family/youth empowerment and engagement during office visits for children with mild to moderate problems with anxiety. Children coming for routine care at one clinic are screened for anxiety symptoms and seen by either a specially trained provider or one of the clinic's other regular staff members.", 'detailedDescription': 'Children who are thought to have mild to moderate anxiety will, via their parents, be offered the opportunity to receive treatment from their pediatric primary care provider. Providers will either use their existing anxiety approaches or will use those approaches combined with extra communication skills designed to promote patient and parent engagement in care. Children will be seen for up to 4 30-minute visits at 2 week intervals, with a follow-up telephone call 3 months later to asses the impact of treatment. Children with more severe anxiety (or those whose parents so desire) will be referred for specialized mental health care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coming for well-child visit to designated clinical site;\n* SCARED score 25 or greater\n\nExclusion Criteria:\n\n* acute medical illness, SCARED 40 or greater'}, 'identificationModule': {'nctId': 'NCT02441569', 'briefTitle': 'Common Engagement Strategies (Common Factors) for Childhood Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Common Engagement Strategies (Common Factors) for Childhood Anxiety', 'orgStudyIdInfo': {'id': 'P20MH086048', 'link': 'https://reporter.nih.gov/quickSearch/P20MH086048', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Common factors intervention', 'description': 'Children and parents in this arm will be cared for by a provider who has received brief training in common factors patient engagement skills (the intervention) for use in addition to standard anxiety-related advice. Thus this arm will receive common factors engagement training for provider.', 'interventionNames': ['Behavioral: Common factors engagement training for provider', 'Behavioral: Standard pediatric advice for childhood anxiety']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Children and parents in this arm will be cared for by a provider who is able to offer standard pediatric anxiety-related advice (the control intervention). Families will receive standard pediatric advice for childhood anxiety.', 'interventionNames': ['Behavioral: Standard pediatric advice for childhood anxiety']}], 'interventions': [{'name': 'Common factors engagement training for provider', 'type': 'BEHAVIORAL', 'description': 'Primary care providers have received brief training in communication skills designed to promote family engagement in care including understanding of treatment and empowerment.', 'armGroupLabels': ['Common factors intervention']}, {'name': 'Standard pediatric advice for childhood anxiety', 'type': 'BEHAVIORAL', 'description': 'Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.', 'armGroupLabels': ['Common factors intervention', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Pediatric Clinic', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Lawrence S Wissow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Georgetown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}