Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT05568303
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2022-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-04', 'studyFirstSubmitDate': '2022-10-01', 'studyFirstSubmitQcDate': '2022-10-01', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean scores of psychological distress scores among study group post intervention', 'timeFrame': 'two months', 'description': 'Change in mean scores of psychological distress'}, {'measure': 'Change in mean scores of problem solving skills inventor among study group post intervention', 'timeFrame': '2 months', 'description': 'Change in mean scores of problem solving skills inventory'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism disorders, maternal stress'], 'conditions': ['Cognitive Behavioral Therapy and Problem Solving', 'Autism Disorders and Maternal Stress']}, 'descriptionModule': {'briefSummary': 'Cognitive behavioral therapy sessions can effectively reduce distress in mothers of children with autism. here we emphasize on the role of problem solving appraisal in CBT sessions to improve problem solving skills ability and minimize psychological distress . pre- intervention assessment (T1) for all participants , then designed 8 sessions for study group will apply .\n\npost intervention assessment (T2) will conduct immediately after CBT sessions', 'detailedDescription': 'mothers of children with autistic spectrum disorders have a lots of burdens due to child symptoms its, lack of availability of services and limited resources , thus in turn lead them to become unable to face problems/stressors and to be psychological distress. CBT is an effective therapy to minimize stress, anxiety and depression. Mothers who participated in the study recruited from three governmental hospitals that has an out patients clinics specialized in autism and other developmental disorders for children at ElBehairah governate , Egypt . Based on inclusion and exclusion criteria for mothers and their children, mothers informed about the nature of the study and their benefits for participations. assessment tools will use ; depression ,anxiety and stress scale (DAS) and problem solving inventory (PSI). First assessment will occur , then randomly the participants divide into either study ( intervention) group or control group .CBT sessions will provide for study group to enhance their problem solving ability and psychological state. Second assessment (T2) will occur after finishing program sessions for all participants'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': "only mothers of autistics children's involve", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMothers caregivers who have:\n\n* A child with autism spectrum disorders diagnosed science at least 6 months , and her/ his diagnosis done by a psychiatrist\n* Just one child with autistic disorder\n* Their ages between 20-50 years old\n* Did not expose to previous interventional / rehabilitation programs for his/her child.\n\nExclusion Criteria for mothers:\n\n* have a diagnosis of any of psychiatric disorders\n* Being absent more than three sessions in study group\n\nExclusion criteria for children: if they have:\n\n* Intelligence level below 70\n* Have severe deterioration\n* Receive psychiatric medication\n* Have multiple disorders'}, 'identificationModule': {'nctId': 'NCT05568303', 'briefTitle': 'the Role of Problem Solving in Cognitive Behavioral Therapy for Mothers With Autistic Children', 'organization': {'class': 'OTHER', 'fullName': 'Jouf University'}, 'officialTitle': 'The Effect of Cognitive Behavioral Therapy on Psychological Distress Among Mothers of Children With Autism Spectrum Disorders: The Role of Problem-Solving Appraisal', 'orgStudyIdInfo': {'id': '62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study ( interventional ) group', 'description': 'this group received 8 sessions of CBT', 'interventionNames': ['Behavioral: CBT techniques']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'they will receive on intervention sessions or any education researchers makes meeting every month to answer any questions and to maintain continuity of relation with participants'}], 'interventions': [{'name': 'CBT techniques', 'type': 'BEHAVIORAL', 'description': 'through CBT sessions , the participants apply problem solving process in managing their stressors . examining the role of cognitions, emotions, and behaviors to form cause and effect relationship of participants psychological distress', 'armGroupLabels': ['study ( interventional ) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22516', 'city': 'Behera Governate', 'state': 'Beera', 'country': 'Egypt', 'facility': 'Governmental Clinic'}, {'zip': '00966', 'city': 'JOUF', 'country': 'Saudi Arabia', 'facility': 'Enas Mahrous Abdelaziz'}], 'overallOfficials': [{'name': 'Enas M Abdelaziz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jouf University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'based on request from principle investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jouf University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Enas Mahrous AbdelAziz', 'investigatorAffiliation': 'Jouf University'}}}}