Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIR/Floortime™ Therapy Program in Children with Developmental Risk

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 DIR/Floortime™ therapy program is an approach that uses play as a therapeutic tool, emphasising the importance of interaction involving affect and excitement in a child's development. DIR/Floortime™ therapy program aims to support the child's development with a family-centred perspective by evaluating the child and the family together. DIR/Floortime™ 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 child's 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 DIR/Floortime™ 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 DIR/Floortime™ 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 (n=17) in which the DIR/Floortime™ therapy program will be applied and intervention group (n=17) in which the SCASI training program will be applied in addition to the DIR/Floortime™ therapy program. The DIR/Floortime™ 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.

Study Overview

• Status: Completed
• Conditions: Children with Developmental Risk
• Intervention / Treatment: Other: The DIR/Floortime™ Therapy Program; Other: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34015
    • Biruni University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The child is between 1-3 years old
• The language of the parents and the child is Turkish
• Assessment of SİATT pre-test result as "developmental risk"
• Parents' willingness to participate in the study

Exclusion Criteria:

• Any cognitive impairment in the parents that may interfere with communication
• Illiteracy of parents
• The child has orthopedic, neurological disability(s) other than developmental risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The group in which the Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) training program will be applied in addition to the DIR/Floortime™ therapy program	Other: The DIR/Floortime™ Therapy Program; The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks; Other: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program; The Social-Communication Area Developmental Screening Test for Infants and Young Children (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
Active Comparator: Control Group; The group in which the DIR/Floortime™ therapy program will be applied	Other: The DIR/Floortime™ Therapy Program; The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI)	12 weeks
Age and Stages Questionnarie (ASQ)	12 weeks
Age and Stages Questionnaires: Social-Emotional (ASQ-SE)	12 weeks
Brief Infant and Toddler Social Emotional Assessment (BITSEA)	12 weeks

Collaborators and Investigators

• Sponsor: Biruni University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Children; Social Communication; Developmental Risk; DIR/Floortime; Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI)
• Other Study ID Numbers: buhucgun05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No