Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones

this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.

Study Overview

• Status: Completed
• Conditions: Healthy; Development, Infant; Motor Delay; Term
• Intervention / Treatment: Other: Training program

Detailed Description

Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.

Intervention group:

1. Four training sessions (before the baby is 1 month old, at 3 months, at 6, and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given bits of advice.
2. Three evaluations of motor milestones at 9, 12, and 15 months old.

Control group:

1. Three evaluations of motor milestones at 9, 12, and 15 months old.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Aragón
    • Zaragoza, Aragón, Spain, 50019
      • Universidad San Jorge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 9 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy-term infants
• Male and female
• Apgar score of at least 7 in the first minute and at five minutes.
• Natural or cesarean birth
• Absence of congenital malformations or orthopedic injury
• Absence of known congenital or genetic pathology
• Normal neurological medical examination of the newborn at hospital discharge.

Exclusion Criteria:

• Newborns who have required hospitalization before being enrolled.
• Multiple births

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Four training sessions (before the baby is 1 month old, at 3 months, at 6 and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given advices. Three evaluations of motor milestones at the age of 9, 12, and 15 months old	Other: Training program; Training program consisting in 4 sessions with information about milestones to achieve and advices for motor development. Triptychs and short videos containing the main points containing the main points.
No Intervention: Control group; Three evaluations of motor milestones at the age of 9, 12, and 15 months old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the Alberta Infant Motor Scale (AIMS) at month 9	AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.	9 months old
Score of the Alberta Infant Motor Scale (AIMS) at month 12	AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.Depending on the score, the percentile is obtained.	12 months old
Score of the Alberta Infant Motor Scale (AIMS) at month 15	AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.	15 months old

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Investigators: Principal Investigator: Luis Fernández Sola, Physical Th, Universidad San Jorge; Study Director: Beatriz Cano Díez, Physical Th, Universidad San Pablo CEU

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): January 17, 2023

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: motor development; motor milestones; newborn; term
• Other Study ID Numbers: ufernandez2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD after deidentified
• IPD Sharing Time Frame: 5 years
• IPD Sharing Access Criteria: Información will be shared with editors or other investigators
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No