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

Study Overview
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Brief Summary
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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
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infants of the intervention group are enrolled by the main investigator in the hospital in the next two or three days after birth. Infants of the control group are enrolled by the pediatricians at the age of 9 months old in the Primary Care Service. 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. Two evaluations of motor milestones at the age of 9 and 12 months old. Control group: 1. Two evaluations of motor milestones at the age of 9 and 12 months old.

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

Conditions
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Term, Healthy, Motor Delay, Development, Infant

Intervention / Treatment
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* Other: Training program


Participation Criteria
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Eligibility Criteria
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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 With or without in vitro fertilization Absence of congenital malformations or orthopedic injury Absence of known congenital or genetic pathology Normal neurological medical examination of the newborn at hospital discharge or at the first medical examination in the Primary Care Service Exclusion Criteria: Newborns who have required hospitalization before being enrolled. Multiple births

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention and control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. Two evaluations of motor milestones at the age of 9 and 12 months old | Other: Training program<br>* 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.<br>|
| No Intervention: Control group<br>Two evaluations of motor milestones at the age of 9 and 12 months old | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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term, newborn, motor development, motor milestones