Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-27 @ 10:00 AM
Study NCT ID:
NCT06367192
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
School Readiness Intervention for Preschool Children With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-04-11', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Intervention Measure', 'timeFrame': 'Collected immediately after the intervention', 'description': 'A brief (4-items) Likert-scale questionnaire assessing feasibility of the intervention. This measure is completed by care givers and intervention providers.'}, {'measure': 'Acceptability of Intervention Measure', 'timeFrame': 'Collected immediately after the intervention', 'description': 'A brief (4-items) Likert-scale questionnaire assessing acceptability of the intervention. This measure is completed by care givers and intervention providers.'}], 'secondaryOutcomes': [{'measure': 'Bracken School Readiness Assessment - 3rd Edition', 'timeFrame': 'Baseline and Collected immediately after the intervention', 'description': 'A Standardized assessment of school readiness skills for preschool children.'}, {'measure': 'Woodcock Johnson Tests of Achievement - Fourth Edition', 'timeFrame': 'Baseline and Collected immediately after the intervention', 'description': 'A standardized measure of reading, mathematics, and spelling.'}, {'measure': 'NIH Toolbox Flanker Test', 'timeFrame': 'Baseline and Collected immediately after the intervention', 'description': 'A computerized test of inhibitory control.'}, {'measure': 'Head-Toes-Knees-Shoulders Revised', 'timeFrame': 'Baseline and Collected immediately after the intervention', 'description': 'A behavioral measure that examines self-regulation in preschool children.'}, {'measure': 'Behavior Rating Inventory of Executive Functioning Preschool or Child', 'timeFrame': 'Baseline and Collected immediately after the intervention', 'description': 'A parent rating form that assesses executive functioning using a set of standardized questions.'}, {'measure': 'The Parenting Scale', 'timeFrame': 'Baseline and Collected immediately after the intervention', 'description': 'A self-report measure completed by caregivers assessing their parenting skills.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org/protocols', 'label': 'Clinical Trials Open at St. Jude'}]}, 'descriptionModule': {'briefSummary': 'The study participant is being asked to take part in this clinical trial, a type of research study, because the participant is a young child with sickle cell disease or the caregiver of a child with sickle cell disease. This study is being done to test a school readiness program for children with sickle cell disease (ages 3.5-6,5 years old).\n\nPrimary Objective\n\nAssess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 3.5-6.5) diagnosed with sickle cell disease.\n\nSecondary Objectives\n\nObjective 1:\n\nMeasure preliminary efficacy of the adapted school readiness intervention compared to routine care among preschool children ages (3.5-6.5) diagnosed with sickle cell disease.\n\nObjective 2:\n\nExamine implementation factors (i.e., barriers and facilitators) during post-intervention.', 'detailedDescription': '* Group randomization- Parent and child will be randomly selected (like the flip of a coin) to receive either the school readiness intervention or the standard school resources.\n* Attend virtual classroom program sessions- If the participant is in the school readiness group, the caregiver, will attend about 8 weeks of sessions virtually with a teacher and a caregiver of a child with sickle cell, for a total of 8 sessions. The sessions will be during the summer and done in a group. Each session will last about 1 ½ hours and will be video recorded. These sessions will be shared with another researcher for feedback and consistency.\n* Complete a caregiver interview-If you are in the school readiness group, a member of the study team will interview you after the virtual classroom sessions are over. The interview will take about 15-20 minutes and will be audio recorded. The caregiver will be asked for suggestions and how satisfied with the program.\n* Complete assessments - Caregiver and child will complete a set of assessments that evaluate school readiness skills (e.g., early math and reading), child behaviors, and parent-child relationships before and after the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '78 Months', 'minimumAge': '42 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Diagnosed with sickle cell disease of any genotype.\n* Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)\n* Age 3.5-6.5 years inclusive at the time of enrollment\n* English as the primary language\n* Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines\n\nCaregiver Participants\n\n* Have a child diagnosed with SCD of any genotype between the ages of 3.5-6.5 years and enrolled in SCCRIP\n* English as the primary language\n\nExclusion Criteria\n\n* Do not have a child diagnosed with SCD of any genotype between the ages of 3.5-6.5 years and enrolled in SCCRIP\n* Non-English speakers'}, 'identificationModule': {'nctId': 'NCT06367192', 'briefTitle': 'School Readiness Intervention for Preschool Children With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'School Readiness Intervention for Preschool Children With Sickle Cell Disease', 'orgStudyIdInfo': {'id': 'SKITS2'}, 'secondaryIdInfos': [{'id': 'K23HL166697', 'link': 'https://reporter.nih.gov/quickSearch/K23HL166697', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Readiness Intervention', 'description': '* Attend virtual classroom program sessions- If participants are in the school readiness group, the caregiver, will attend about 8 weeks of sessions virtually with a teacher or social worker and a caregiver of a child with sickle cell, for a total of 8 sessions. The sessions will be during the summer and done in a group. Each session will last about 1 ½ hours and will be video recorded. \\> •Complete a caregiver interview-If participants are in the school readiness group, a member of the study team will interview you after the virtual classroom sessions are over. The interview will take about 15-20 minutes and will be audio recorded. Participants will be asked for suggestions and how satisfied you were with the program.\n* Complete assessments - Caregiver and participant will complete a set of assessments that evaluate school readiness skills (e.g., early math and reading), child behaviors, and parent-child relationships before and after the intervention.', 'interventionNames': ['Behavioral: The adapted Kids in Transition to School Intervention']}, {'type': 'OTHER', 'label': 'Control: Standard school resources', 'description': 'Parents will be provided with information about preschool programs available in the community and age appropriate books for their children', 'interventionNames': ['Behavioral: Standard school resources']}], 'interventions': [{'name': 'The adapted Kids in Transition to School Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Kids in Transition to School (KITS)'], 'description': "An intensive, school readiness intervention designed to improve preschoolers' social skills, early literacy, numeracy, and self-regulation skills at high risk for academic difficulties. The intervention is delivered virtually over 8 weeks with caregivers and intentionally occurs over the summer when there is a gap in preschool services.", 'armGroupLabels': ['Readiness Intervention']}, {'name': 'Standard school resources', 'type': 'BEHAVIORAL', 'description': 'Information about local preschool programs and age appropriate books for children will be provided.', 'armGroupLabels': ['Control: Standard school resources']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'ANDREW HEITZER, PhD', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}, {'name': 'ANDREW HEITZER, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'centralContacts': [{'name': 'ANDREW HEITZER, PhD', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '866-278-5833'}], 'overallOfficials': [{'name': 'ANDREW Heitzer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be made available at the time of article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.', 'accessCriteria': 'Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}