Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-03-22 @ 5:44 AM
Study NCT ID:
NCT02199704
Status:
COMPLETED
Last Update Posted:
2016-08-02
First Post:
2014-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003702', 'term': 'Delusions'}, {'id': 'D006212', 'term': 'Hallucinations'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-31', 'studyFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2014-07-23', 'lastUpdatePostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Psychotic Symptom Rating Scales (PSYRATS)', 'timeFrame': 'Initial Ax, Multiple Baseline Ax, Final Baseline Ax, Up to 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks.', 'description': 'Ax from 0 - 16 weeks.'}, {'measure': 'Parenting and Family Adjustment Scale (PAFAS)', 'timeFrame': 'Initial Ax, Multiple Baselines, Final Baseline, Support Sessions, End Ax, Follow Up. Ax from 0 - 16 weeks.', 'description': 'Ax from 0 - 16 weeks.'}], 'secondaryOutcomes': [{'measure': 'Eyberg Child Behaviour Inventory (ECBI)', 'timeFrame': 'Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.', 'description': 'Ax from 0 - 16 weeks.'}, {'measure': 'Parenting Task Checklist (PTC)', 'timeFrame': 'Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.', 'description': 'Ax from 0 - 16 weeks.'}, {'measure': 'Depression Anxiety and Stress Scale (DASS-21)', 'timeFrame': 'Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.', 'description': 'Ax from 0 - 16 weeks.'}, {'measure': 'Work and Social Adjustment Scale (WSAS)', 'timeFrame': 'Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.', 'description': 'Ax from 0 - 16 weeks.'}, {'measure': 'Warwick-Edinburgh Mental Well-being Scale (WEMWBS)', 'timeFrame': 'Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.', 'description': 'Ax from 0 - 16 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parenting', 'Psychosis', 'Schizophrenia', 'Delusions', 'Hallucinations'], 'conditions': ['Schizophrenia', 'Spectrum', 'Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of the case series study is to explore if a self directed version of the Positive Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with psychosis who are parents.', 'detailedDescription': 'As above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Parents/caregivers (mothers or fathers) with a Schizophrenia-spectrum diagnosis who are:\n\n 2\\. Aged 18 years or more\n\n 3\\. Have at least one child aged 3-10 years old\n\n 4\\. Have a least 10 hours contact time per week with the child.\n\n 5\\. Identify difficulties in parenting during assessment\n\nExclusion Criteria:\n\n* 1\\. Parents/caregivers and family members who do not have good working knowledge of English. They should have enough practical experience to be able to adequately use the English language to understand and respond to questions, to read and complete questionnaires\n\n 2\\. Families who do not have at least one adult who has basic literacy skills\n\n 3\\. Families where there is known intention for their children to be taken into care or where the parent(s) have no regular contact with the index child\n\n 4\\. Parents with a clinical schizophrenia-spectrum diagnosis who have recently been discharged from acute in-patient care for their condition and have less than four weeks of stabilisation of psychotic experiences (operationally defined as no significant change to management or severity of symptoms in a four-week period since discharge as assessed from case notes). This is because if a potential parent with schizophrenia had recently required an inpatient stay, it is important to give them sufficient time to readjust to living in the community and ensure sufficient time is provided for symptom stabilisation before taking part\n\n 5\\. Families seeking support from services regarding child management issues\n\n 6\\. Families actively involved in another current cognitive behavioural therapy based intervention'}, 'identificationModule': {'nctId': 'NCT02199704', 'briefTitle': 'Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series', 'orgStudyIdInfo': {'id': '14/NW/0126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'No control or comparison arm.', 'description': 'This case series study has no control or comparison arm. There is only one arm being evaluated (the self directed parenting intervention).', 'interventionNames': ['Other: Self Directed Positive Parenting Program']}], 'interventions': [{'name': 'Self Directed Positive Parenting Program', 'type': 'OTHER', 'otherNames': ['"Every Parent\'s Self Help Workbook"'], 'description': 'Individuals with psychosis who are parents will receive a copy of the "Every Parent\'s Self Help Workbook" (Markie-Dadds, Sanders \\& Turner, 1999) and up to ten sessions of support. This is a case series study.', 'armGroupLabels': ['No control or comparison arm.']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9PL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Prof Rachel Calam, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lancashire Care NHS Foundation Trust', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist', 'investigatorFullName': 'Dr Chris Taylor', 'investigatorAffiliation': 'University of Manchester'}}}}