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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04693494
Enrollment
82
Registered
2021-01-05
Start date
2019-12-01
Completion date
2023-01-17
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development, Infant, Healthy, Motor Delay, Term

Keywords

motor milestones, term, newborn, motor development

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.

Interventions

OTHERTraining 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.

Sponsors

Universidad San Jorge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double blinded: spontaneous behavior of babies is evaluated, that doesn't depend of having knowledge of the intervention. Outcomes assessor doesn't know the evaluated baby group.

Intervention model description

Intervention and control group.

Eligibility

Sex/Gender
ALL
Age
1 Days to 9 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Score of the Alberta Infant Motor Scale (AIMS) at month 99 months oldAIMS 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 1212 months oldAIMS 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.
Score of the Alberta Infant Motor Scale (AIMS) at month 1515 months oldAIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026