Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT06927518
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Receptive Language Intervention vs Individual Therapy for Preschool Children With 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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-07-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laura Mize Teach Me To Talk receptive language checklist, Me To Talk receptive language checklist,', 'timeFrame': '2 months', 'description': 'Laura Mize, a pediatric speech-language pathologist, created the "Teach Me To Talk" resources, including a Receptive Language Skills Checklist. This checklist is designed to help parents, therapists, and educators assess and track a child\'s receptive language development, particularly for toddlers and young children with language delays or disorders, including autism.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '38435203', 'type': 'BACKGROUND', 'citation': 'Gajre MP, Shah M, Pradhan SV, Aseri H. Examining the Impact of Group-Based Social Skills Intervention in Autistic Children Aged Eight to 15 Years. Cureus. 2024 Feb 1;16(2):e53376. doi: 10.7759/cureus.53376. eCollection 2024 Feb.'}, {'type': 'BACKGROUND', 'citation': 'Akbar RF, Kiyani HS, Saqulain G. Effectiveness of group therapy versus individual therapy in acquisition of pre-linguistic skills in children with expressive language disorders. The Rehabilitation Journal. 2023.'}]}, 'descriptionModule': {'briefSummary': "Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social communication and social interaction and the presence of restricted, repetitive behaviors. Atypical behaviors, conditioning, and difficulties interacting with others are emblems of Autism spectrum disorder (ASD). Autism spectrum disorder (ASD) frequently affects receptive language skills essential for comprehension and communication. Early intervention is crucial for optimizing language outcomes. This randomized controlled trial (RCT) investigates the comparative efficacy of receptive language intervention (RLI) in group versus individual therapy settings for preschool children with ASD.\n\nThis study aims to investigate the efficacy of receptive language intervention (RLI) in group versus individual therapy settings for preschool children with Autism Spectrum Disorder (ASD) aged 3-5 years. The study aims to address the knowledge gap regarding optimal delivery methods for receptive language interventions. Twenty preschool children (ages 3-5) with ASD will be randomly assigned to either group (n=10) or individual (n=10) therapy conditions. Outcome measures will assess by Laura Mize Teach Me To Talk receptive language checklist, noted before therapy and after completing 20 sessions post-therapy (after 7 weeks). Statistical analysis was done using SPSS 20. An Independent t-test was utilized to see any difference between groups. The study's findings will inform evidence-based practice, enhancing receptive language skills in preschool children with ASD. The study could give precious perceptivity to clinicians, preceptors, and policymakers, helping them make informed, substantiation-based opinions about the most effective and doable intervention strategies. The expected outcomes include comparable receptive language outcomes between group and individual therapy, identification of setting-specific benefits and challenges, and child characteristics influencing treatment response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 3 to 5 years diagnosed with ASD.\n* Children who are able to attend regular therapy sessions as scheduled in the study (either group or individual therapy).\n* Both male and female will be included.\n\nExclusion Criteria:\n\n* Children with co-occurring severe medical conditions.\n* Children who have already received intensive speech and language therapy for receptive language skills within the last 6 months.\n* Children with behavioral issues so severe (e.g., aggression, extreme hyperactivity) that they might disrupt group therapy sessions or be unable to focus in individual therapy.'}, 'identificationModule': {'nctId': 'NCT06927518', 'briefTitle': 'Effects of Receptive Language Intervention vs Individual Therapy for Preschool Children With Autism Spectrum Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Receptive Language Intervention vs Individual Therapy for Preschool Children With', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/24/0655'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual Therapy', 'description': '14 participant will receive individual therapy. Each participant will receive 3 session per week for 2 Months.', 'interventionNames': ['Other: Receptive language intervention by using the total communication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Therapy', 'description': '16 participants will divided in 2 groups. each group will receive 3 session per week for 2 Months.', 'interventionNames': ['Other: Receptive language intervention by using the total communication']}], 'interventions': [{'name': 'Receptive language intervention by using the total communication', 'type': 'OTHER', 'description': 'Receptive language intervention using Total Communication (TC) for children with autism can be highly effective. Total Communication involves using a combination of communication methods to support language comprehension and expression. It recognizes that individuals with autism often benefit from multi-modal communication rather than relying solely on spoken language.', 'armGroupLabels': ['Group Therapy', 'Individual Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Irum Khara, MS', 'role': 'CONTACT', 'phone': '03203986465'}], 'facility': 'Irum Khara', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Imran Amjad, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}, {'name': 'Syeda Mariam Zahra, MS SLP', 'role': 'CONTACT', 'email': 'mariam.zahra@riphah.edu.pk', 'phone': '03344164996'}], 'overallOfficials': [{'name': 'Syeda Mariam Zahra, MS SLP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}