NCT04288973

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

February 24, 2020

Last Update Submit

October 17, 2023

Conditions

Keywords

mother-infant relationshiptechnologiesdisability

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    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)

Study Arms (2)

Typical development children

Control sample

Diagnostic Test: Microsoft Kinect Detection during mother child interaction

Children with developmental disability

Clinical sample

Diagnostic Test: Microsoft Kinect Detection during mother child interaction

Interventions

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

Children with developmental disabilityTypical development children

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Chronological age 18-36 months
  • IQ \>= 60
  • Autonomous walk

You may not qualify if:

  • \- ASD diagnosis
  • control sample
  • Chronological age 18-36 months
  • At term birth
  • previous hospitalization
  • psychopathologies
  • intellectual disability
  • psychopathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 28, 2020

Study Start

March 11, 2019

Primary Completion

May 30, 2021

Study Completion

December 30, 2022

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations