Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06292520
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of ABLLS-R and Portage Guide in the Development of Receptive Language Skills Autism Spectrum Disorder.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2023-12-25', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ABLLS-R for the development of receptive language in children with Autism', 'timeFrame': '6 months', 'description': 'Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) is a criterion referenced assessment tool, curriculum planning manual, and tracking system for the prerequisite skills required for the development of basic language and communication as well as skills required to support learning in significant academic, adaptive, and motor domains assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes.'}, {'measure': 'Portage Guide for the development of receptive language in children with Autism', 'timeFrame': '6 months', 'description': 'A home-based early intervention program called Portage Guide to Early Education is for preschoolers who are developmentally delayed. It consists of a method of teaching parents how to instruct their own children, a set of reading materials, and the triadic model of service delivery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorders', 'Non-verbal Learning Disorder']}, 'referencesModule': {'references': [{'pmid': '22350453', 'type': 'BACKGROUND', 'citation': 'Maljaars J, Noens I, Scholte E, van Berckelaer-Onnes I. Language in low-functioning children with autistic disorder: differences between receptive and expressive skills and concurrent predictors of language. J Autism Dev Disord. 2012 Oct;42(10):2181-91. doi: 10.1007/s10803-012-1476-1.'}, {'pmid': '31920593', 'type': 'BACKGROUND', 'citation': 'Sket GM, Overfeld J, Styner M, Gilmore JH, Entringer S, Wadhwa PD, Rasmussen JM, Buss C. Neonatal White Matter Maturation Is Associated With Infant Language Development. Front Hum Neurosci. 2019 Dec 17;13:434. doi: 10.3389/fnhum.2019.00434. eCollection 2019.'}, {'pmid': '26408635', 'type': 'BACKGROUND', 'citation': 'Plesa Skwerer D, Jordan SE, Brukilacchio BH, Tager-Flusberg H. Comparing methods for assessing receptive language skills in minimally verbal children and adolescents with autism spectrum disorders. Autism. 2016 Jul;20(5):591-604. doi: 10.1177/1362361315600146. Epub 2015 Sep 25.'}, {'pmid': '30078460', 'type': 'BACKGROUND', 'citation': 'Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'Language is the system someone uses to communicate with another person. This covers the origins and construction of words, their definitions, and the use of language in various contexts. In normally developing children, receptive language skills are typically much more advanced than expressive language skills. However, some studies found that toddlers and kids with ASD had a relatively greater impairment in receptive language skills than in expressive language skills. The study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder (N=12).\n\nThe study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABLLS-R protocol and other will receive Interventions under portage guide protocol. The data will be analysed by using SPSS 22 statistical software. The results of the study of both the groups will be compared and conclusion will be made on the basis of results. Receptive language skills are crucial for communication and social interaction. Research comparing these assessment tools can contribute to the development of more effective early intervention programs for children with ASD. By identifying the most appropriate assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes. By understanding the strengths and limitations of each assessment tool, professionals can create more individualized treatment plans for children with ASD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with autism spectrum disorder with mild to moderate severity level will be included in the study.\n* The age range of the children will be from three years to seven years.\n\nExclusion Criteria:\n\n* Children with other neurological disorders or any comorbid conditions will be excluded from the study.\n* Children who are not participated in any kind of other intervention.'}, 'identificationModule': {'nctId': 'NCT06292520', 'briefTitle': 'Comparison of ABLLS-R and Portage Guide in the Development of Receptive Language Skills Autism Spectrum Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'ABLLS-R and Portage Guide in the Development of Receptive Language Skills in Children With Autism Spectrum Disorder.', 'orgStudyIdInfo': {'id': '4847'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABLLS-R protocol', 'description': 'The study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and compare their effectiveness in developing the Receptive.', 'interventionNames': ['Other: ABLLS-R protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Portage Guide Protocol', 'description': 'The study will evaluate Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder.', 'interventionNames': ['Other: Portage Guide Protocol']}], 'interventions': [{'name': 'Portage Guide Protocol', 'type': 'OTHER', 'description': 'Portage Guide Protocol will be given to this group The study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABL', 'armGroupLabels': ['Portage Guide Protocol']}, {'name': 'ABLLS-R protocol', 'type': 'OTHER', 'description': 'ABLLS-R protocol will be given to this group', 'armGroupLabels': ['ABLLS-R protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05309', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Bases Institute', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Aleena Irum, MS-SLP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}