Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01243905
Status:
UNKNOWN
Last Update Posted:
2011-01-19
First Post:
2010-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-18', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 21 weeks', 'timeFrame': 'Baseline, 21 weeks', 'description': 'GHQ:It is the shorten version of the General Health Questionaire 60. It consists four categories;somatic symptoms,anxiety and insomnia,social dysfunction and depressive tendency.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks', 'timeFrame': 'the baseline, 7weeks, 21weeks'}, {'measure': 'Change from baseline in the total score of the Abnormal Behavior Checklist at 7 weeks', 'timeFrame': 'the baseline, 7weeks, 21weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pervasive Developmental Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness of group psychoeducation for the psychological distress of mothers with the children of high-functioning pervasive developmental disorder and for their behavior based on disorder traits.', 'detailedDescription': 'Pervasive Developmental Disorder (PDD) is defined by its unique symptoms such as qualitative impairment in social interaction and communication and restricted repetitive and stereotyped patterns of behavior and interests. Recently, studies have been conducted on PDD without mental retardation, and have reported that the morbidity of PDD is 0.6%-1.7％． Several studies have focused on distress of the mothers of PDD facing atypical development of their children. Some of them have indicated the associations between depression and family history of PDD. Therefore it is important to pay attention to parental mental health.\n\nIn Western countries, researchers have investigated the effectiveness of various psychotherapeutic techniques such as childcare counseling and education for mothers about how to treat their children with PDD. It has been reported that one of them which innovates pragmatical methods to manage their children and parental educational programs made improvement in parental adaptation to their children and parental mental health.\n\nHowever, to the best of our knowledge, few studies have shown the effectiveness of family intervention about PDD in Japan, despite widely implementation of family psychoeducation with various approaches in medical center, public health department. New research may be needed to establish rigorous evidence base for improvement of parental mental health and of behaviors of their children with PDD.\n\nThe investigators hypothesized that psychoeducation programs for mothers in addition to treatment as usual to their children would be more effective for parental mental health and behaviors of their children with PDD than treatment usual to their children alone.\n\nThe purpose of this study is to examine the effectiveness of psychoeducation to the psychological distress of mothers with the children of high-functioning PDD and to behaviors of the children affected by disorder traits, in a randomized controlled trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Mothers whose children have been diagnosed with any disorders by DSM-Ⅳ-TR as: 1) Autistic disorder and not mental retardation; 2) Asperger disorder; or 3) Pervasive developmental disorder not otherwise specified and not mental retardation\n2. Children were diagnosed at more than 3 months before allocation\n3. Children were between 2 and 6.5 years and have more than 6 months as pre-school period at allocation\n4. Mothers who are native speakers of Japanese.\n5. Mothers who are biological mother of and actually bringing their children.\n\nExclusion Criteria:\n\n1. Mothers who are at risk of taking an emotional toll and unable to understand the contents of psychoeducation for any reason.\n2. Mothers who are not allowed to participate in this study judged by the doctors of the children for any reason.'}, 'identificationModule': {'nctId': 'NCT01243905', 'briefTitle': 'Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Nagoya City University'}, 'officialTitle': 'Group Psychoeducational Program for Mothers of Preschool Children With High Functional Pervasive Developmental Disorders: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NCUPsychiatry003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Family psychoeducation plus TAU', 'description': 'Family psychoeducational therapy in addition to treatment as usual for the child (TAU)', 'interventionNames': ['Other: Family psychoeducational therapy plus TAU']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Treatment as usual for the child (TAU)', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'Family psychoeducational therapy plus TAU', 'type': 'OTHER', 'description': 'Group psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians', 'armGroupLabels': ['Family psychoeducation plus TAU']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Treatment as usual administered by physicians', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '467-8601', 'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Atsurou Yamada, MD, PhD', 'role': 'CONTACT', 'email': 'atsurou@med.nagoya-cu.ac.jp', 'phone': '+52-851-5511', 'phoneExt': '3970'}], 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masako Suzuki, Medical Bachelor', 'role': 'CONTACT', 'email': 'masako8886@leaf.ocn.ne.jp'}, {'name': 'Masako Suzuki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}], 'overallOfficials': [{'name': 'Masako Suzuki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nagoya City University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nagoya City University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Masako Suzuki', 'oldOrganization': 'Nagoya City University Graduate School of Medical Sciences'}}}}