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.
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
- Conditions the study is for
- Developmental Disability, Parent Child Relationship
- 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.
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 group | Role | What they receive |
|---|---|---|
| Typical development children | Control sample Receives: Diagnostic Test: Microsoft Kinect Detection during mother child interaction | |
| Children with developmental disability | Clinical 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.
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)
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.
- First posted28 Feb 2020
- Study start11 Mar 2019
- Primary completion30 May 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPATIA@Lecco - Tavolo 13: Mother-Infant Interaction Kinect Analysis (MIIKA)
- ClinicalTrials.gov ID
- NCT04288973
- Acronym / sponsor ID
- MIIKA / 653
- Keywords
- mother-infant relationship, technologies, disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical development children | – | Diagnostic Test: Microsoft Kinect Detection during mother child interactionControl sample |
| Children with developmental disability | – | Diagnostic Test: Microsoft Kinect Detection during mother child interactionClinical sample |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Clinical population is enrolled from the hospital unit. Control population is enrolled from kindergarten.
Key inclusion criteria (5 listed)
- Chronological age 18-36 months
- IQ >= 60
- Autonomous walk
- Chronological age 18-36 months
- At term birth
Key exclusion criteria (8 listed)
- ASD diagnosis
- control sample
- previous hospitalization
- psychopathologies
- Mothers Inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microsoft Kinect Detection during mother child interactionmethodology based on RGB-D sensors applied to the setting of free parent-infant interaction | Diagnostic test | Children with developmental disability, Typical development children |
Primary outcome
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)
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
Integration of automatic computational metrics obtained by the kinect data extraction with behavioral assessment made through PICCOLO observational checklist
Time frame: 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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.