Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-28 @ 12:28 PM
Study NCT ID:
NCT06831851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-26
First Post:
2025-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Music and Storytelling on Linguistic, Socioemotional, and Adaptive Development in Children Aged 12-36 Months: an Intervention Protocol in Municipal Early Childhood Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'No other parties are masked in this study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Developmental Assessment using Bayley-III Scales of Infant and Toddler Development', 'timeFrame': 'The primary outcome measure (developmental assessment using Bayley-III) will be assessed at baseline (before the intervention) and after 4 months of intervention, focusing on linguistic, socio-emotional, and adaptive behavior domains', 'description': "Developmental Assessment using the Bayley-III Scales The primary outcome measure will focus on evaluating the child's development through the Bayley Scales of Infant and Toddler Development (Bayley-III), a widely used tool for assessing multiple domains of early childhood development, including cognitive, motor, language, socio-emotional, and adaptive behavior. The aim is to detect any developmental delays or deviations, providing critical information for early intervention. The Bayley-III will be administered to children up to 42 months of age to ensure comprehensive developmental screening across different stages."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Environmental enrichment', 'Child development', 'Early childhood education', 'Adaptive behavior', 'Randomized clinical trial'], 'conditions': ['Child Development', 'Adaptive Behavior', 'Early Child Development', 'Music Education', 'Preschool Education']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial aims to evaluate the impact of a structured enriched environment on the linguistic, adaptive behavior, and socioemotional development of children aged 12 to 36 months. The study addresses two main questions:\n\nDoes the intervention improve linguistic, adaptive behavior, and socioemotional development compared to standard care? Does parental guidance amplify the benefits of the intervention?\n\nParticipants will be randomly assigned to one of two groups:\n\nIntervention Group:\n\nChildren will participate in musical activities twice per week (singing, exploring simple instruments, and musical games) and daily storytelling sessions using interactive and visual aids.\n\nWithin this group, parents in the "with guidance" subgroup will attend biweekly meetings to learn strategies for reinforcing the intervention at home, while the "without guidance" subgroup will not include parental training.\n\nControl Group:\n\nChildren will receive standard care complemented by alternative artistic and pedagogical activities (e.g., drawing, painting), without the structured intervention.', 'detailedDescription': 'This study aims to evaluate the impact of an enriched intervention program on early childhood development, emphasizing the role of parental involvement. Participants will be randomly assigned to two main groups:\n\nControl Group:\n\nChildren will follow routine childcare activities, including artistic and educational engagements (e.g., drawing, painting, storytelling).\n\nIntervention Group:\n\nChildren in this group will participate in a structured program combining daily storytelling sessions and weekly musicalization activities.\n\nThis group will be further divided into two subgroups:\n\nWith Parental Guidance: Parents or guardians will attend bi-weekly guidance meetings to receive strategies for reinforcing the intervention at home.\n\nWithout Parental Guidance: No parental meetings will be conducted; children will participate in the program independently.\n\nIntervention Activities:\n\nThe intervention includes:\n\nStorytelling: Interactive, daily sessions (30 minutes/day) designed to foster creativity and imagination using visual and verbal methods.\n\nMusicalization: Interactive, twice-weekly sessions (40 minutes each) incorporating singing, rhythm games, and exploration of simple musical instruments to enhance motor and cognitive skills.\n\nAssessment Measures:\n\nThe primary developmental domains-linguistic, socio-emotional, and adaptive behaviors-will be assessed using the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary measures include parental adherence (in the guidance subgroup) and engagement levels during activities.\n\nThis pilot study will provide foundational data to support the development of larger-scale, evidence-based interventions focused on enhancing early childhood developmental outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren of both sexes, aged between 12 and 36 months. Enrolled full-time in Municipal Early Childhood Education Centers (CMEIs). Attending with a daily workload of 10 hours, five days a week.\n\nExclusion Criteria:\n\nDiagnosis of atypical neurodevelopment. Use of sedative or stimulant medications for memory. Undergoing physical therapy for the locomotor system. Presence of any clinical or functional condition that prevents participation. More than five consecutive absences from the intervention program.'}, 'identificationModule': {'nctId': 'NCT06831851', 'acronym': 'MUS-STORY', 'briefTitle': 'Effects of Music and Storytelling on Linguistic, Socioemotional, and Adaptive Development in Children Aged 12-36 Months: an Intervention Protocol in Municipal Early Childhood Centers', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal de Pernambuco'}, 'officialTitle': 'The Influence of Music and Storytelling on the Linguistic, Socioemotional, and Adaptive Development of Children Aged 12-36 Months: an Intervention Protocol in an Enriched Environment Conducted in Municipal Early Childhood Education Centers (CMEIs)', 'orgStudyIdInfo': {'id': 'INF-MUSIC-STORY01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group with Parental Guidance', 'description': 'Children in this group will participate in structured storytelling sessions (30 minutes per day, once a week) and music education activities (40 minutes, twice per week) in an enriched learning environment. The intervention aims to enhance cognitive, linguistic, socio-emotional, and motor development.\n\nAdditionally, parents or guardians will attend 8 biweekly guidance sessions (60 minutes each), where they will be trained in strategies to reinforce storytelling and musical activities at home. These sessions will provide tools to improve parent-child interaction and promote continuity of learning beyond the daycare setting', 'interventionNames': ['Behavioral: Storytelling Sessions', 'Behavioral: Music Education Sessions', 'Behavioral: Parental Guidance Sessions']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group without Parental Guidance', 'description': 'Children in this group will participate in structured storytelling sessions (30 minutes per day, once a week) and music education activities (40 minutes, twice per week) in an enriched learning environment. The intervention is designed to stimulate cognitive, linguistic, socio-emotional, and motor development through interactive and engaging activities.\n\nUnlike the parental guidance group, this intervention does not include parental training sessions. The activities will be conducted exclusively in the daycare setting, without reinforcement at home', 'interventionNames': ['Behavioral: Storytelling Sessions', 'Behavioral: Music Education Sessions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Children in this group will receive standard daycare activities without structured intervention. Activities will include artistic and pedagogical tasks (e.g., drawing, painting, modeling) as part of their regular curriculum. Additionally, storytelling will be conducted once a week, but without a structured approach or the integration of music education as applied in the experimental groups.\n\nThis group serves as a comparator to assess the effects of storytelling and music education interventions on cognitive, linguistic, socio-emotional, and motor development', 'interventionNames': ['Behavioral: Standard Daycare Activities']}], 'interventions': [{'name': 'Storytelling Sessions', 'type': 'BEHAVIORAL', 'description': 'Children will participate in structured storytelling sessions, held once a week for 30 minutes per session. The sessions will use interactive narrative techniques, including voice modulation, gestures, and visual aids, to enhance cognitive, linguistic, and socio-emotional development. The intervention is designed to promote active engagement, stimulate imagination, and improve attention and language skills in early childhood.', 'armGroupLabels': ['Intervention Group with Parental Guidance', 'Intervention Group without Parental Guidance']}, {'name': 'Music Education Sessions', 'type': 'BEHAVIORAL', 'description': 'Children will participate in structured music education sessions, conducted twice per week for 40 minutes each. The sessions will include rhythm exercises, vocalization, body percussion, and instrumental exploration using age-appropriate musical instruments. Activities will be designed to enhance cognitive, motor, and socio-emotional development by fostering auditory discrimination, fine and gross motor coordination, and social interaction. The intervention follows an interactive and play-based methodology, ensuring active engagement and progressive learning.', 'armGroupLabels': ['Intervention Group with Parental Guidance', 'Intervention Group without Parental Guidance']}, {'name': 'Parental Guidance Sessions', 'type': 'BEHAVIORAL', 'description': 'Parents or guardians will attend 8 biweekly training sessions (60 minutes each) designed to equip them with strategies for cognitive, linguistic, and socio-emotional stimulation in early childhood. The sessions will include practical guidance on storytelling techniques, musical interaction, and play-based learning to reinforce the intervention at home. The goal is to create continuity between structured intervention activities and the home environment, maximizing developmental outcomes for the children. Sessions will be interactive, combining theoretical content with practical exercises and demonstrations', 'armGroupLabels': ['Intervention Group with Parental Guidance']}, {'name': 'Standard Daycare Activities', 'type': 'BEHAVIORAL', 'description': 'Children in this group will participate in regular daycare activities, including artistic and pedagogical tasks such as drawing, painting, and modeling. These activities are part of the standard curriculum and do not include structured storytelling or music education interventions', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50790020', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'contacts': [{'name': 'Sandra Lopes Souza, PhD in Morphofunctional Scienc', 'role': 'CONTACT', 'email': 'sanlopesufpe@gmail.com', 'phone': '+55 81 98740-2484'}], 'facility': 'Universidade Federal de Pernambuco (UFPE) - Department of Neuropsychiatry and Behavioral Sciences', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'centralContacts': [{'name': 'Aline A Lima, Master in Arts and Music, Mast', 'role': 'CONTACT', 'email': 'aline.alima@ufpe.br', 'phone': '+ 55 81 996094074'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal de Pernambuco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordination for the Improvement of Higher Education Personnel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MSc in Neuroscience', 'investigatorFullName': 'Aline A de Lima, MA', 'investigatorAffiliation': 'Universidade Federal de Pernambuco'}}}}