Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06929858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Cognitive-Behavioral Strategies on Nurses Caring for Children With Autism Spectrum Disorder
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-04-15', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Efficacy', 'timeFrame': '2 months', 'description': 'Tool: Nursing Self-Efficacy Scale, Total scores range from 10 to 40, with higher scores indicating greater self-efficacy.'}], 'secondaryOutcomes': [{'measure': 'Sense of Coherence', 'timeFrame': '2 months', 'description': 'Tool: Sense of Coherence Scale, Total scores range from 13 to 91, with higher scores indicating a stronger sense of coherence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nurses Behaviors']}, 'referencesModule': {'references': [{'pmid': '41277762', 'type': 'DERIVED', 'citation': 'Zoromba MA, Alenezi A, El-Monshed AH, Loutfy A, Ali AM, Alkubati SA, El-Gazar HE. Effect of Cognitive-Behavioural Strategies on Self-Efficacy, Sense of Coherence and Psychological Ownership Among Nurses Caring for Children With Autism Spectrum Disorder: A Randomised Control Trial. J Psychiatr Ment Health Nurs. 2025 Nov 24. doi: 10.1111/jpm.70066. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if a structured training program in cognitive-behavioral strategies can improve:\n\nSelf-efficacy: The belief in one's ability to succeed in specific tasks or situations.\n\nSense of coherence: A perception of life as comprehensible, manageable, and meaningful.\n\nPsychological ownership: A sense of possession or attachment to one's job or role.\n\nThese outcomes are critical for nurses working with children with ASD, as their role involves unique emotional and professional challenges. The study will use a rigorous scientific approach to assess the effectiveness of the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'genderBased': False, 'healthyVolunteers': True, 'eligibilityCriteria': 'Registered nurses who provide direct care to children with ASD in settings such as hospitals, clinics, or specialized care centers.\n\nInclusion Criteria:\n\n* At least 6 months of experience caring for children with ASD.\n* Currently employed in a direct caregiving role for these children.\n\nExclusion Criteria:\n\n* Nurses with prior formal training in cognitive-behavioral therapy.\n* Nurses planning to leave their position during the study period.'}, 'identificationModule': {'nctId': 'NCT06929858', 'briefTitle': 'Effect of Cognitive-Behavioral Strategies on Nurses Caring for Children With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Port Said University'}, 'officialTitle': 'Effect of Cognitive-Behavioral Strategies on Self-Efficacy, Sense of Coherence, and Psychological Ownership Among Nurses Caring for Children With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'SCBR-375/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBS Intervention group', 'description': 'Interventional study gropu receives the cognitive-behavioral strategies training', 'interventionNames': ['Other: cognitive-behavioral strategies training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Continues with usual practice'}], 'interventions': [{'name': 'cognitive-behavioral strategies training', 'type': 'OTHER', 'description': 'A structured training program focused on cognitive-behavioral strategies tailored to the challenges of caring for children with ASD. Examples include:\n\nTechniques to manage stress (e.g., relaxation exercises). Cognitive reframing to address negative thoughts. Coping skills to enhance resilience in a demanding work environment.', 'armGroupLabels': ['CBS Intervention group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Port Said University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}