Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-05 @ 5:06 PM
Study NCT ID:
NCT02935218
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2016-08-30', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'written feedback', 'timeFrame': '12 weeks', 'description': 'the participants provide written feedback regarding the changes due to the parental skills training'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Borderline Personality Disorder']}, 'referencesModule': {'references': [{'pmid': '27980787', 'type': 'DERIVED', 'citation': 'Renneberg B, Rosenbach C. "There is not much help for mothers like me": Parenting Skills for Mothers with Borderline Personality Disorder - a newly developed group training program. Borderline Personal Disord Emot Dysregul. 2016 Dec 1;3:16. doi: 10.1186/s40479-016-0050-4. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': "N=15 mothers with Borderline Personality Disorder who had young children (aged 0-6 years) participated in a 12-week training program. To estimate the participants' impairment, parental stress and psychological distress were assessed before the training. After the training, participants and trainers were asked to provide feedback regarding the valuation of and the changes due to the training."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Borderline diagnosis in mothers\n* Infants between 6 months and 6 years\n* Mothers and their children must be in regular contact with each other\n\nExclusion Criteria:\n\n* Acute child endangerment\n* Maternal acute suicidality'}, 'identificationModule': {'nctId': 'NCT02935218', 'briefTitle': 'Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program', 'organization': {'class': 'OTHER', 'fullName': 'Freie Universität Berlin'}, 'officialTitle': 'Parenting Skills for Mothers With Borderline Personality Disorder: A Newly Developed Group Training Program', 'orgStudyIdInfo': {'id': 'RenRos01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Parenting Skills for Mothers with BPD', 'description': 'single-arm study', 'interventionNames': ['Behavioral: Parenting Skills for Mothers with BPD']}], 'interventions': [{'name': 'Parenting Skills for Mothers with BPD', 'type': 'BEHAVIORAL', 'description': 'The cognitive-behavioral Group Training for mothers with BPD consists of 12 weekly sessions promoting parenting skills including primary needs of children, stress and stress management, dealing with conflicts, mindfulness, emotion regulation, routine and flexibility, the role of the body in parenting, basic assumptions about parenting, and self-care.', 'armGroupLabels': ['Parenting Skills for Mothers with BPD']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'qualitative data not suitable for sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Freie Universität Berlin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr. Charlotte Rosenbach', 'investigatorAffiliation': 'Freie Universität Berlin'}}}}