Child DevelopmentMUS-STORYNCT06831851
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
A study testing Storytelling Sessions, Music Education Sessions and Parental Guidance Sessions in people with Child Development and Adaptive Behavior, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Adaptive Behavior, Early Child Development
- What is being tested?
- Storytelling Sessions, Music Education Sessions and Parental Guidance Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jun 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children 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.
Who cannot join
- Diagnosis 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Universidade Federal de Pernambuco (UFPE) - Department of Neuropsychiatry and Behavioral Sciences
Recife, Pernambuco, 50790020
Sandra Lopes Souza, PhD in Morphofunctional Scienc, +55 81 98740-2484, sanlopesufpe@gmail.com
About this study
Official title: 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)
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:
Does the intervention improve linguistic, adaptive behavior, and socioemotional development compared to standard care? Does parental guidance amplify the benefits of the intervention?
Read more
Participants will be randomly assigned to one of two groups:
Intervention Group:
Children will participate in musical activities twice per week (singing, exploring simple instruments, and musical games) and daily storytelling sessions using interactive and visual aids.
Within 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.
Control Group:
Children will receive standard care complemented by alternative artistic and pedagogical activities (e.g., drawing, painting), without the structured intervention.
Read the detailed description
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:
Control Group:
Children will follow routine childcare activities, including artistic and educational engagements (e.g., drawing, painting, storytelling).
Intervention Group:
Children in this group will participate in a structured program combining daily storytelling sessions and weekly musicalization activities.
This group will be further divided into two subgroups:
With Parental Guidance: Parents or guardians will attend bi-weekly guidance meetings to receive strategies for reinforcing the intervention at home.
Without Parental Guidance: No parental meetings will be conducted; children will participate in the program independently.
Intervention Activities:
The intervention includes:
Storytelling: Interactive, daily sessions (30 minutes/day) designed to foster creativity and imagination using visual and verbal methods.
Musicalization: Interactive, twice-weekly sessions (40 minutes each) incorporating singing, rhythm games, and exploration of simple musical instruments to enhance motor and cognitive skills.
Assessment Measures:
The 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.
This pilot study will provide foundational data to support the development of larger-scale, evidence-based interventions focused on enhancing early childhood developmental outcomes.
- Conditions
- Child Development, Adaptive Behavior, Early Child Development, Music Education, Preschool Education
- Being tested
- Storytelling Sessions, Music Education Sessions, Parental Guidance Sessions, Standard Daycare Activities
- Keywords
- Environmental enrichment, Child development, Early childhood education, Adaptive behavior, Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling SessionsBehavioural
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.
Music Education SessionsBehavioural
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.
Parental Guidance SessionsBehavioural
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
Standard Daycare ActivitiesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group with Parental Guidance | Experimental | 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.
Additionally, 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 Receives: Behavioral: Storytelling Sessions; Behavioral: Music Education Sessions; Behavioral: Parental Guidance Sessions |
| Intervention Group without Parental Guidance | Experimental | 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.
Unlike 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 Receives: Behavioral: Storytelling Sessions; Behavioral: Music Education Sessions |
| Control Group | Active comparator | 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.
This group serves as a comparator to assess the effects of storytelling and music education interventions on cognitive, linguistic, socio-emotional, and motor development Receives: Behavioral: Standard Daycare Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Assessment using Bayley-III Scales of Infant and Toddler Development
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start2 Jun 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Responsible party
- Principal investigator, Aline A de Lima, MA, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831851
- Sponsor's protocol ID
- INF-MUSIC-STORY01
- Acronym
- MUS-STORY
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06831851
- Acronym / sponsor ID
- MUS-STORY / INF-MUSIC-STORY01
- Conditions
- Child Development, Adaptive Behavior, Early Child Development, Music Education, Preschool Education
- Keywords
- Environmental enrichment, Child development, Early childhood education, Adaptive behavior, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Does the intervention improve linguistic, adaptive behavior, and socioemotional development compared to standard care? Does parental guidance amplify the benefits of the intervention?
Participants will be randomly assigned to one of two groups:
Intervention Group:
Children will participate in musical activities twice per week (singing, exploring simple instruments, and musical games) and daily storytelling sessions using interactive and visual aids.
Within 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.
Control Group:
Children will receive standard care complemented by alternative artistic and pedagogical activities (e.g., drawing, painting), without the structured intervention.
Detailed description
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:
Control Group:
Children will follow routine childcare activities, including artistic and educational engagements (e.g., drawing, painting, storytelling).
Intervention Group:
Children in this group will participate in a structured program combining daily storytelling sessions and weekly musicalization activities.
This group will be further divided into two subgroups:
With Parental Guidance: Parents or guardians will attend bi-weekly guidance meetings to receive strategies for reinforcing the intervention at home.
Without Parental Guidance: No parental meetings will be conducted; children will participate in the program independently.
Intervention Activities:
The intervention includes:
Storytelling: Interactive, daily sessions (30 minutes/day) designed to foster creativity and imagination using visual and verbal methods.
Musicalization: Interactive, twice-weekly sessions (40 minutes each) incorporating singing, rhythm games, and exploration of simple musical instruments to enhance motor and cognitive skills.
Assessment Measures:
The 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.
This pilot study will provide foundational data to support the development of larger-scale, evidence-based interventions focused on enhancing early childhood developmental outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group with Parental Guidance | Experimental | Behavioral: Storytelling Sessions, Behavioral: Music Education Sessions, Behavioral: Parental Guidance SessionsChildren 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. Additionally, 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 |
| Intervention Group without Parental Guidance | Experimental | Behavioral: Storytelling Sessions, Behavioral: Music Education SessionsChildren 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. Unlike 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 |
| Control Group | Active comparator | Behavioral: Standard Daycare ActivitiesChildren 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. This group serves as a comparator to assess the effects of storytelling and music education interventions on cognitive, linguistic, socio-emotional, and motor development |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 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.
Key exclusion criteria (1 listed)
- Diagnosis 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Storytelling SessionsChildren 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. | Behavioural | Intervention Group with Parental Guidance, Intervention Group without Parental Guidance |
| Music Education SessionsChildren 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. | Behavioural | Intervention Group with Parental Guidance, Intervention Group without Parental Guidance |
| Parental Guidance SessionsParents 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 | Behavioural | Intervention Group with Parental Guidance |
| Standard Daycare ActivitiesChildren 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 | Behavioural | Control Group |
Primary outcome
Developmental Assessment using Bayley-III Scales of Infant and Toddler Development
Time frame: 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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storytelling Sessions, Music Education Sessions and Parental Guidance Sessions in people with Child Development and Adaptive Behavior, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aline A Lima, Master in Arts and Music, Mast (+ 55 81 996094074, aline.alima@ufpe.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Assessment using Bayley-III Scales of Infant and Toddler Development (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.