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

Not Applicable

Completed

• Conditions: Motor Delay; Development, Infant; Term; Healthy
• Interventions: Other: Training program

• Registration Number: NCT04693494
• Lead Sponsor: Universidad San Jorge

Brief Summary

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.

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 Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-12-07
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Study Completion: 2023-01-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Training program	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

Primary Outcome Measures

Name	Time	Method
Score of the Alberta Infant Motor Scale (AIMS) at month 9	9 months old	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.
Score of the Alberta Infant Motor Scale (AIMS) at month 15	15 months old	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.
Score of the Alberta Infant Motor Scale (AIMS) at month 12	12 months old	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.

Trial Locations

Locations (1)

Universidad San Jorge; 🇪🇸 Zaragoza, Aragón, Spain