Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-24 @ 10:05 AM
Study NCT ID:
NCT00578318
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
African American Knowledge Optimized for Mindfully Healthy Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ab2892@georgetown.edu', 'phone': '2026872392', 'title': 'Alfiee M. Breland-Noblem Ph.D., MHSc', 'organization': 'Georgetown University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We lost 3 participants prior to intervention completion of the intervention which impacted results.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event reporting occurred for the duration of data collection with this phase of the study from 2007 - 2011, including a 3 month follow up period after the last patient completed the protocol.', 'description': "Since the participants in the study were at-risk for depression or met criteria for depression and the purpose of the study was to assist the participants in securing treatment for their depression, we did not assess any of the patients as at risk for adverse events since they were being followed clinically by the study PI and the PI's mentors.", 'eventGroups': [{'id': 'EG000', 'title': 'Motivational Interviewing Active', 'description': '2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Delayed Control', 'description': 'At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Attendance at First Depression Treatment Appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Interviewing Active', 'description': '2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention'}, {'id': 'OG001', 'title': 'Delayed Control', 'description': 'At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients)', 'description': 'Patients were randomized to the intervention or a delayed control group. The primary outcome was bifurcated as yes or no to specify whether or not the patient attended the first available depression treatment appointment scheduled after he/she completed the AAKOMA protocol. The average time to attendance at the first session was approximately 3-4 weeks and during this intermediate time between completion of the protocol and initiation of treatment all patients were followed by study staff).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Motivational Interviewing Active', 'description': '2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention'}, {'id': 'FG001', 'title': 'Delayed Control', 'description': 'At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study patients were recruited from the local community using tested, strategic community engagement procedures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Motivational Interviewing Active', 'description': '2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention'}, {'id': 'BG001', 'title': 'Delayed Control', 'description': 'At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-15', 'studyFirstSubmitDate': '2007-12-19', 'resultsFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-15', 'studyFirstPostDateStruct': {'date': '2007-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attendance at First Depression Treatment Appointment', 'timeFrame': 'Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients)', 'description': 'Patients were randomized to the intervention or a delayed control group. The primary outcome was bifurcated as yes or no to specify whether or not the patient attended the first available depression treatment appointment scheduled after he/she completed the AAKOMA protocol. The average time to attendance at the first session was approximately 3-4 weeks and during this intermediate time between completion of the protocol and initiation of treatment all patients were followed by study staff).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '16768016', 'type': 'BACKGROUND', 'citation': 'Breland-Noble AM, Bell C, Nicolas G. Family first: the development of an evidence-based family intervention for increasing participation in psychiatric clinical care and research in depressed African American adolescents. Fam Process. 2006 Jun;45(2):153-69. doi: 10.1111/j.1545-5300.2006.00088.x.'}, {'pmid': '22984337', 'type': 'RESULT', 'citation': 'Breland-Noble AM, Bell CC, Burriss A, Poole HK; The AAKOMA Project Adult Advisory Board. The Significance of Strategic Community Engagement in Recruiting African American Youth & Families for Clinical Research. J Child Fam Stud. 2012 Apr 1;21(2):273-280. doi: 10.1007/s10826-011-9472-1. Epub 2011 Mar 4.'}, {'pmid': '22354616', 'type': 'RESULT', 'citation': 'Breland-Noble AM; AAKOMA Project Adult Advisory Board. Community and treatment engagement for depressed African American youth: the AAKOMA FLOA pilot. J Clin Psychol Med Settings. 2012 Mar;19(1):41-8. doi: 10.1007/s10880-011-9281-0.'}, {'pmid': '21512751', 'type': 'RESULT', 'citation': 'Breland-Noble AM, Bell CC, Burriss A; AAKOMA Project Adult Advisory Board. "Mama just won\'t accept this": adult perspectives on engaging depressed African American teens in clinical research and treatment. J Clin Psychol Med Settings. 2011 Sep;18(3):225-34. doi: 10.1007/s10880-011-9235-6.'}, {'pmid': '20564682', 'type': 'RESULT', 'citation': 'Breland-Noble AM, Burriss A, Poole HK; AAKOMA PROJECT Adult Advisory Board. Engaging depressed African American adolescents in treatment: lessons from the AAKOMA PROJECT. J Clin Psychol. 2010 Aug;66(8):868-79. doi: 10.1002/jclp.20708.'}], 'seeAlsoLinks': [{'url': 'http://www.aakomaproject.org', 'label': 'Study Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to better understand how African American families identify and treat emotional and behavioral concerns associated with depression in their adolescent youth. The goals of the study included (a) identifying factors associated with participation in psychiatric research and treatment and (b) developing an intervention to increase participation in psychiatric research and treatment.', 'detailedDescription': "The aim of this study was to obtain an in-depth understanding of African Americans' perceptions of barriers to adolescent and family engagement in psychiatric treatment and research utilizing a mixed methods approach in two Phases. Phase I consisted of data collected via surveys, focus groups and individual interviews with African American adults and youth. The data generated in Phase I provided a foundation for the domains incorporated into manual development and therapist training procedures of the subsequent intervention phase of the project (Phase II).\n\nAfter the research team developed the depression treatment engagement intervention, the intervention was pilot tested in a sample of depressed African American youth and families (Phase II)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons who self-identify as Black or African American\n* Adolescents aged 11 to 17 at the time of recruitment\n* Adult parents\n* Parent consent and adolescent assent\n* Demonstrated cognitive ability to understand participation\n\nExclusion Criteria:\n\n* Diminished capacity to participate'}, 'identificationModule': {'nctId': 'NCT00578318', 'acronym': 'AAKOMA', 'briefTitle': 'African American Knowledge Optimized for Mindfully Healthy Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Treatment Engagement in Psychiatric Clinical Research and Care for Depressed African American Adolescents', 'orgStudyIdInfo': {'id': 'Pro00006780 (9065)'}, 'secondaryIdInfos': [{'id': '1K01MH073814-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K01MH073814-01A1', 'type': 'NIH'}, {'id': '5K01MH073814-02', 'link': 'https://reporter.nih.gov/quickSearch/5K01MH073814-02', 'type': 'NIH'}, {'id': '5K01MH073814-03', 'link': 'https://reporter.nih.gov/quickSearch/5K01MH073814-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing Active', 'description': 'Patients received a stepped progression of talk based treatment utilizing Motivational Interviewing as the basis.', 'interventionNames': ['Behavioral: Motivational Interviewing Active']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Control', 'description': 'Patients received Treatment as usual (TAU) (i.e. no specific intervention and supportive check-ins from the study staff)', 'interventionNames': ['Behavioral: Motivational Interviewing Active']}], 'interventions': [{'name': 'Motivational Interviewing Active', 'type': 'BEHAVIORAL', 'description': 'Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.', 'armGroupLabels': ['Delayed Control', 'Motivational Interviewing Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Child and Family Study Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Alfiee M Breland-Noble, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alfiee Breland-Noble', 'investigatorAffiliation': 'Georgetown University'}}}}