Promoting Motor Development in Infants and Toddlers Through Education and Early Detection

NCT ID: NCT07091474

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-09-01

Brief Summary

The "Little Movers" study promotes healthy motor development in early childhood by providing education to caregivers and professionals in the child's environment and by implementing early detection strategies for motor delays.

The primary prevention component includes structured educational workshops designed for three age groups: 0-12 months, 13-24 months, and 25-36 months. These workshops focus on typical motor milestones, the importance of active play, early stimulation strategies, and how to recognize early warning signs of motor development delays. Participation impact will be measured using pre- and post-workshop surveys and semi-structured interviews with parents, caregivers, and educators.

The secondary and tertiary prevention component consists of a longitudinal observational study that follows infants aged 0 to 12 months. Motor development will be assessed using validated tools, including the Standardized Infant Hand Assessment (s-HAI), the Hammersmith Infant Neurological Examination (HINE), the Infant Motor Profile (IMP), and the Ages and Stages Questionnaire (ASQ-3). Infants with typical development will be reassessed annually, while those at risk or showing signs of motor delay will be monitored monthly. The goal is to detect motor delays as early as possible to allow timely referral and intervention.

Conditions

Typical Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Families and Early Childhood Educators

This cohort includes families of children aged 0-36 months and early childhood educators enrolled in structured educational workshops. The intervention consists of age-specific sessions tailored to three cohorts (0-12 months, 13-24 months, 25-36 months). Sessions provide education on motor milestones, the role of play, early stimulation techniques, and early warning signs of motor delays. Parents, caregivers, and educators participate in interactive discussions, practical activities, and resource sharing to enhance knowledge and support early motor development.

Educational Workshops for Parents and Early Educators

Intervention Type: BEHAVIORAL

A structured series of age-specific educational workshops designed for parents, caregivers, and early childhood educators of children aged 0-36 months. The workshops are organized into three cohorts (0-12 months, 13-24 months, 25-36 months) and focus on typical motor milestones, active play, early stimulation strategies, and recognition of early warning signs of motor delays. Sessions include interactive activities, discussions, and distribution of educational resources. Pre- and post-workshop surveys and semi-structured interviews are conducted to evaluate changes in knowledge and attitudes.

Infants (0-36 months)

This cohort includes infants aged 0-36 months who will undergo motor development assessments using validated tools, including the Standardized Infant Hand Assessment (s-HAI), Ages and Stages Questionnaire (ASQ-3), Hammersmith Infant Neurological Examination (HINE), and Infant Motor Profile (IMP). Assessments are scheduled annually for typically developing infants and monthly for those at risk or showing early signs of motor delays.

Motor Development Assessment in Children 0-36 Months

Intervention Type: OTHER

Comprehensive motor development assessments performed on infants aged 0-36 months using validated tools (Standardized Infant Hand Assessment \[s-HAI\], Hammersmith Infant Neurological Examination \[HINE\], Infant Motor Profile \[IMP\], and Ages and Stages Questionnaire \[ASQ-3\]). These evaluations aim to collect normative data on typical early motor development and to identify early signs of motor delays or neurological conditions, enabling timely referral and intervention. Assessments are conducted annually for typically developing infants and monthly for those identified as at risk.

Interventions

Educational Workshops for Parents and Early Educators

A structured series of age-specific educational workshops designed for parents, caregivers, and early childhood educators of children aged 0-36 months. The workshops are organized into three cohorts (0-12 months, 13-24 months, 25-36 months) and focus on typical motor milestones, active play, early stimulation strategies, and recognition of early warning signs of motor delays. Sessions include interactive activities, discussions, and distribution of educational resources. Pre- and post-workshop surveys and semi-structured interviews are conducted to evaluate changes in knowledge and attitudes.

Intervention Type: BEHAVIORAL

Motor Development Assessment in Children 0-36 Months

Comprehensive motor development assessments performed on infants aged 0-36 months using validated tools (Standardized Infant Hand Assessment \[s-HAI\], Hammersmith Infant Neurological Examination \[HINE\], Infant Motor Profile \[IMP\], and Ages and Stages Questionnaire \[ASQ-3\]). These evaluations aim to collect normative data on typical early motor development and to identify early signs of motor delays or neurological conditions, enabling timely referral and intervention. Assessments are conducted annually for typically developing infants and monthly for those identified as at risk.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Legal guardians or primary caregivers of children aged 0 to 36 months enrolled in the participating daycare center. Early childhood educators working with children aged 0 to 36 months in the same center.

Infants aged 0 to 12 months enrolled in the participating daycare center. Infants must not have a diagnosed neuromotor or neurological condition at the time of enrollment. Written informed consent must be obtained from a parent or legal guardian.

Exclusion Criteria

Children with diagnosed neurological or genetic conditions affecting motor development. Families or educators who decline participation or do not provide informed consent. Children or families not enrolled in the participating daycare center.

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Little movers

Identifier Type: -

Identifier Source: org_study_id