Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT06893666
Status:
COMPLETED
Last Update Posted:
2025-07-15
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Play Based Therapy on Attention Level of Children With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010989', 'term': 'Play Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NHS Attention and Listening Screener', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The screener was designed to measure attention and listening of children. It is dichotomous (yes/no) comprising of 9 items according to age rang of 3-5 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Play Therapy', 'Down Syndrome', 'Attention', 'Randomized Control Trial', 'Child Development'], 'conditions': ['Down Syndrome']}, 'referencesModule': {'references': [{'pmid': '30376388', 'type': 'BACKGROUND', 'citation': 'Lu WP, Tsai WH, Lin LY, Hong RB, Hwang YS. The Beneficial Effects of Massage on Motor Development and Sensory Processing in Young Children with Developmental Delay: A Randomized Control Trial Study. Dev Neurorehabil. 2019 Oct;22(7):487-495. doi: 10.1080/17518423.2018.1537317. Epub 2018 Oct 30.'}, {'type': 'BACKGROUND', 'citation': 'Manshi, Dimple Choudhry, Anshu Kumari, & Priyanka Gulati. (2023). To Compare the Attention Span of Down Syndrome Children with Healthy Children of Same Age Group. International Journal of Medical Science and Diagnosis Research, 7(2). https://doi.org/10.32553/ijmsdr.v7i2.976'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the attention level of children with down syndrome receiving play based therapy as compared to children receiving child centered play therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 3-5 years\n* Gender: Both male and female\n* Children who are currently taking speech therapy sessions with parental involvement.\n* Medically stable children with no severe ongoing health issues that could interfere with their participation in the study.\n\nExclusion Criteria:\n\n* Children with severe sensory impairments\n* Co-morbid neurological conditions that may confound the results\n* Children who received intervention from any other institute'}, 'identificationModule': {'nctId': 'NCT06893666', 'briefTitle': 'Effects of Play Based Therapy on Attention Level of Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Play Based Therapy on Attention Level of Children With Down Syndrome', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/24/0678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Play based therapy', 'description': 'Experimental group was given pay based therapy. Total of 4 sessions were given each session of 40min.', 'interventionNames': ['Other: Play based therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Child centered play therapy', 'description': 'Control group was given child centered play therapy. Total of 4 sessions were given each session of 40min.', 'interventionNames': ['Other: Child centered play therapy']}], 'interventions': [{'name': 'Play based therapy', 'type': 'OTHER', 'description': 'Experimental group was given pay based therapy. Total of 4 sessions were given each session of 40min.', 'armGroupLabels': ['Play based therapy']}, {'name': 'Child centered play therapy', 'type': 'OTHER', 'description': 'Control group was given child centered play therapy. Total of 4 sessions were given each session of 40min.', 'armGroupLabels': ['Child centered play therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Aleena Irum', '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'}}}}