Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-28 @ 2:55 PM
Study NCT ID:
NCT00050557
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
2002-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Psychoeducation for Children With Mood Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-02', 'studyFirstSubmitDate': '2002-12-13', 'studyFirstSubmitQcDate': '2002-12-13', 'lastUpdatePostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mood Severity Index', 'timeFrame': 'Measured at Months 6 and 12'}], 'secondaryOutcomes': [{'measure': 'Rage Index (MRS irritability + disruptive-aggressive items)', 'timeFrame': 'Measured at Months 6 and 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mood Disorders']}, 'referencesModule': {'references': [{'pmid': '23800483', 'type': 'DERIVED', 'citation': 'Boylan K, Macpherson HA, Fristad MA. Examination of disruptive behavior outcomes and moderation in a randomized psychotherapy trial for mood disorders. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):699-708. doi: 10.1016/j.jaac.2013.04.014.'}, {'pmid': '19736358', 'type': 'DERIVED', 'citation': 'Fristad MA, Verducci JS, Walters K, Young ME. Impact of multifamily psychoeducational psychotherapy in treating children aged 8 to 12 years with mood disorders. Arch Gen Psychiatry. 2009 Sep;66(9):1013-21. doi: 10.1001/archgenpsychiatry.2009.112.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.', 'detailedDescription': "Mood disorders among youth are a major health concern. Existing mood disorder studies focus on adults, and studies that focus on effective intervention strategies for youth with mood disorders are needed. This 8-session study is an adjunct to ongoing medication management and individual and family psychotherapy for children with mood disorders.\n\nIn this study, parents learn about mood disorders, their treatments, and how to work effectively with mental health and school systems. Parents also practice problem-solving and communication skills for symptom management. Children learn about mood disorders and their treatments, including basic cognitive-behavioral principles. Children also learn and practice anger management, problem-solving, and communication skills.\n\nPatients and their families are randomly assigned to 1 of 2 groups. The first group receives 8 sessions of psychoeducation plus treatment as usual (TAU). The second group is a wait-list control in which participants receive only TAU. Patients and caregivers undergo a variety of interviews, tests, and behavioral observations throughout the study. Anxiety, depression, psychosocial stressors, manic symptoms, and children's experiences with psychotropic medications and with treatment or service providers are assessed. Caregivers, teachers, and family friends undergo interviews and make observations of the patient's level of support, general appearance and behavior, and overall functional capacity. The extent to which caregivers agree on the need for treatment and the extent of caregivers' knowledge of mood disorders is also assessed. Assessments occur at 3, 6, 12, 15, and 18 months after study enrollment. A comprehensive assessment is conducted at study entry and 1 year later."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Major depressive disorder, dysthymic disorder, or bipolar disorder (Type I or II)\n* IQ greater than 70\n* At least one parent/caregiver willing to participate in the study\n* Able to attend six or more of the eight treatment sessions with at least 1 parent'}, 'identificationModule': {'nctId': 'NCT00050557', 'briefTitle': 'Family Psychoeducation for Children With Mood Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Family Psychoeducation: Efficacy in Child Mood Disorders', 'orgStudyIdInfo': {'id': 'R01MH061512', 'link': 'https://reporter.nih.gov/quickSearch/R01MH061512', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH061512', 'link': 'https://reporter.nih.gov/quickSearch/R01MH061512', 'type': 'NIH'}, {'id': 'DSIR CT-S'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual', 'interventionNames': ['Behavioral: Multifamily Psychoeducation Group (MFPG)', 'Behavioral: Treatment as usual (TAU)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment', 'interventionNames': ['Behavioral: Multifamily Psychoeducation Group (MFPG)', 'Behavioral: Treatment as usual (TAU)']}], 'interventions': [{'name': 'Multifamily Psychoeducation Group (MFPG)', 'type': 'BEHAVIORAL', 'description': 'MFPG will include 8 weekly 90-minute group therapy sessions.', 'armGroupLabels': ['1', '2']}, {'name': 'Treatment as usual (TAU)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive standard care for mood disorders.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Mary A. Fristad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mary Fristad', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Psychiatry', 'investigatorFullName': 'Mary Fristad', 'investigatorAffiliation': 'Ohio State University'}}}}