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Developmental DisabilityMIIKANCT04288973

Mother-Infant Interaction Kinect Analysis (MIIKA)

An observational study of Developmental Disability and Parent Child Relationship, run by IRCCS Eugenio Medea at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An innovative methodology is developed to better understand parent-infant relationships. RGB-D sensors (such as Microsoft Kinect) give us the opportunity of online skeleton extraction based on the joints architecture of human bodies. Read more about this study

Who is it for?
Ages 18 to 36 months
What is being tested?
Microsoft Kinect Detection during mother child interaction
How many people
31 participants
Where
1 siteItaly
Study dates
11 Mar 2019to 30 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 36 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: Clinical population is enrolled from the hospital unit. Control population is enrolled from kindergarten.

Who may be able to join

  • Chronological age 18-36 months
  • IQ >= 60
  • Autonomous walk
  • Chronological age 18-36 months
  • At term birth

Who cannot join

  • ASD diagnosis
  • control sample
  • previous hospitalization
  • psychopathologies
  • Mothers Inclusion criteria
  • > 18 y.o. Exclusion criteria
  • intellectual disability
  • psychopathologies

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS E. Medea

    Bosisio Parini, Lecco, 23842

Other trials in Italy

About this study

Official title: EMPATIA@Lecco - Tavolo 13: Mother-Infant Interaction Kinect Analysis (MIIKA)

An innovative methodology is developed to better understand parent-infant relationships. RGB-D sensors (such as Microsoft Kinect) give us the opportunity of online skeleton extraction based on the joints architecture of human bodies. These technologies provide automatic quantitative information of dyadic play, in order to get micro and macro features of the dynamic flow occurring during the interaction. This methodology looks at both behavioral features and objective measurement of spatial proximity and variations during free and structured interactions.

Read the detailed description

RATIONALE:

Children developmental outcomes are known to be shaped by the early context of care and caregiver-infant interaction: an early sensitive caregiving environment provides an optimal emotional context for children's early brain maturation. Consequently, the multilayered and complex interactional processes occurring between infants and their mothers is of vital importance for healthy developmental trajectories. Although mother-infant communication is expressed and regulated using multiple modalities, only few studies focused on the role of body movements within the dyadic communication. Observational instruments - such as PICCOLO (Parenting Interactions with Children-Checklist of Observations Linked to Outcomes) - are useful to get the outstanding characteristics of the dynamicity and complexity of parent-infant relationships, but advances in technology allows us to analyze the flow of movements characterizing information exchanges in the bidirectional process of the parent-infant relationship. Spatial proximity is a core aspect of early dyadic relationships. The temporal and spatial reliability of automatic and computational methods, together with the decreasing costs of technology, are paving the way to the intersection of behavioral and technological techniques in both clinical and research fields. Nevertheless, to the best of our knowledge, kinematic full skeleton registration of mother-infant interaction in a free-play setting with children 18-36 months has not yet been explored both in at-typical and atypical development dyads. Indeed, previous studies assessed social interactions using automatic and computational methods, but mostly focusing on gesture and posture, gaze and mimics, quantity of body, facial and hand movements.

SPECIFIC AIM 1: To identify spatial proximity features during free and structured dyadic interaction of typical development dyads and its association with mother and infant characteristics EXPERIMENTAL DESIGN AIM 1: mother-infant dyads will be asked to play within a specific perimeter that correspond to the detection area of Microsoft Kinect. The play session is divided into 3 phases: (1) free play. Some standard toys are positioned on the floor. (2) tower-task: mother and child are asked to play in order to build a tower with some cubes. (3) Empathy task: the mother is asked to pretend to hurt herself until a "stop" signal from the experimenter. Each session will be videotaped and data from Microsoft Kinect will be detected. Mothers will be asked to answer some questionnaires and expert coders will do behavioral coding with PICCOLO. Spatial proximity measures will be developed through algorithms able to extract, from Kinect row data, measures of approaches and separations of the dyad and mother and child's reciprocal contributions SPECIFIC AIM 2: to understand differences regarding the use of spatial proximity and reciprocal contributions of mother and infant both in typical and atypical dyads EXPERIMENTAL DESIGN AIM 2: children with neurodevelopmental disabilities and their mothers will be asked to play in the same setting explained in "experimental design 1". Data and proximity patterns that will emerge from typical development dyads will be compared to proximity patterns of atypical development children dyads, in order to understand how neurodevelopmental disabilities affect mother-infant interaction from a spatial and motor point of view.

SIGNIFICANCE AND INNOVATION Although mother-infant communication is expressed and regulated using multiple modalities, only few studies focused on the role of body movements and spatial proximity within dyadic communication. This study wants to develop and test an innovative methodology based on RGB-D sensors applied to the setting of free parent-infant interaction. Automatic quantitative information of the dyad will provide micro and macro features of the dynamic flow occurring during the interaction. Thus, automatic quantitative information will supplement behavioral assessments, enriching these observations with objective measurement of spatial proximity and variations during free and structured interactions.

Being tested
Microsoft Kinect Detection during mother child interaction
Keywords
mother-infant relationship, technologies, disability
Medical subject headings
Developmental Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microsoft Kinect Detection during mother child interactionDiagnostic test

    methodology based on RGB-D sensors applied to the setting of free parent-infant interaction

Study groups in NCT04288973
Study groupRoleWhat they receive
Typical development childrenControl sample
Receives: Diagnostic Test: Microsoft Kinect Detection during mother child interaction
Children with developmental disabilityClinical sample
Receives: Diagnostic Test: Microsoft Kinect Detection during mother child interaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proximity features identification

    identification, using Microsoft Kinect, of patterns that are typical of mother-infant interaction in the context of both typical development and developmental neurodisability. Patterns are extracted thanks to the generation of an algorithm that is able to extract data provided by Miscrosoft Kinect

    Measured: Mother-infant interaction occurs when the chld is between 18-36 months of age (6 months after the enrollment, that occurs betrween 12-18 months of age of the child)

  2. Integration of automatic computational metrics obtained by the kinect data extraction with behavioral assessment made through PICCOLO observational checklist

    to compare and integrate automatic computational metrics extracted from Microsoft Kinect with behavioral assessments of the interaction. PICCOLO (Parenting Interactions with Children: Checklist of Observations Linked to Outcomes) is the validated observational tool used for the assessment of the mother-infant interaction. The parenting skills profile obtained from PICCOLO will be paired to metrics extracted from Microsoft Kinect, facilitating and objectivizing features of the mother-infant interaction.

    Measured: Mother-infant interaction occurs when the child is between 18-36 months of age (6 months after the enrollment, that occurs betrween 12-18 months of age of the child)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start11 Mar 2019
  3. Primary completion30 May 2021
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04288973
Sponsor's protocol ID
653
Acronym
MIIKA
Status last verified
Oct 2023
First submitted
24 Feb 2020
Last updated
18 Oct 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Developmental Disability and Parent Child Relationship, run by IRCCS Eugenio Medea at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proximity features identification (time frame: Mother-infant interaction occurs when the chld is between 18-36 months of age (6 months after the enrollment, that occurs betrween 12-18 months of age of the child)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.

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