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

May 13, 2024 updated by: Luis Fernandez, Universidad San Jorge
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Score of the Alberta Infant Motor Scale (AIMS) at month 9
Time Frame: 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.
9 months old
Score of the Alberta Infant Motor Scale (AIMS) at month 12
Time Frame: 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.
12 months old
Score of the Alberta Infant Motor Scale (AIMS) at month 15
Time Frame: 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.
15 months old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad San Jorge

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luis Fernández Sola, Physical Th, Universidad San Jorge
  • Study Director: Beatriz Cano Díez, Physical Th, Universidad San Pablo CEU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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