Viewing Study NCT06345170



Ignite Creation Date: 2024-05-06 @ 8:21 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06345170
Status: RECRUITING
Last Update Posted: 2024-04-03
First Post: 2024-03-28

Brief Title: Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIRFloortime Therapy Program in Children With Developmental Risk
Sponsor: Biruni University
Organization: Biruni University

Study Overview

Official Title: Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIRFloortime Therapy Program in Children With Developmental Risk
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The term developmental risk is used as a general term for developmental delays observed in infancy and early childhood Developmental delay refers to the delay in children reaching developmental milestones compared to their peers The DIRFloortime therapy program is an approach that uses play as a therapeutic tool emphasising the importance of interaction involving affect and excitement in a childs development DIRFloortime therapy program aims to support the childs development with a family-centred perspective by evaluating the child and the family together DIRFloortime therapy program is known to contribute to the functional and emotional development of children and the development of parenting skills of caregivers The Social-Communication Area Developmental Screening Test for Infants and Young Children SCASI is a parent-reported developmental screening test that aims to identify delays in the social communication area skills of infants and children The SCASI training program is a training program for children and parents developed on the basis of this screening test which includes targeted activities to support the development process according to the childs developmental level To the best of our knowledge there is no study investigating the effect of the SCASI training program applied in addition to the DIRFloortime therapy program in children with risky development The aim of the study is to examine the effect of the SCASI training program applied in addition to the DIRFloortime therapy program in children with risky development A total of 34 children with developmental risk between the ages of 1 and 3 will included in the study Participants will randomly divided into two groups control group n17 in which the DIRFloortime therapy program will be applied and intervention group n17 in which the SCASI training program will be applied in addition to the DIRFloortime therapy program The DIRFloortime therapy program will be applied by the therapist in the clinic for 50 minutes 2 days a week for 12 weeks and the SCASI training program will be applied by the parents at home 2 days a week for an average of 30 minutes a day for 12 weeks Demographic and clinic informations SCASI test Age and Stages Questionnarie ASQ Age and Stages Questionnaires Social-Emotional ASQ-SE and Brief Infant and Toddler Social Emotional Assessment BITSEA will be used as outcome measures in the study
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None