Children with Developmental RiskNCT06345170
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
A study testing The DIR/Floortime™ Therapy Program and The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program in people with Children with Developmental Risk, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Children with Developmental Risk
- What is being tested?
- The DIR/Floortime™ Therapy Program and The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2022to 1 May 2024
- Phase
- Interventional
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Children with Developmental Risk
- Being tested
- The DIR/Floortime™ Therapy Program, The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program
- Keywords
- Children, Developmental Risk, DIR/Floortime, Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI), Social Communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The DIR/Floortime™ Therapy ProgramOther
The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks
The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Other: The DIR/Floortime™ Therapy Program; Other: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program |
| Control Group | Active comparator | The group in which the DIR/Floortime™ therapy program will be applied Receives: Other: The DIR/Floortime™ Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI)
Measured: 12 weeks
Age and Stages Questionnarie (ASQ)
Measured: 12 weeks
Age and Stages Questionnaires: Social-Emotional (ASQ-SE)
Measured: 12 weeks
Brief Infant and Toddler Social Emotional Assessment (BITSEA)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Oct 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children with Developmental RiskStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hikmet Ucgun, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345170
- Sponsor's protocol ID
- buhucgun05
- Status last verified
- May 2024
- First submitted
- 28 Mar 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 DIR/Floortime™ Therapy Program in Children with Developmental Risk
- ClinicalTrials.gov ID
- NCT06345170
- Acronym / sponsor ID
- buhucgun05
- Conditions
- Children with Developmental Risk
- Keywords
- Children, Developmental Risk, DIR/Floortime, Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI), Social Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 3 Apr 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: The DIR/Floortime™ Therapy Program, Other: The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training ProgramThe 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 |
| Control Group | Active comparator | Other: The DIR/Floortime™ Therapy ProgramThe group in which the DIR/Floortime™ therapy program will be applied |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| The DIR/Floortime™ Therapy ProgramThe DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks | Other | Control Group, Intervention Group |
| The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training ProgramThe 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 | Other | Intervention Group |
Primary outcome
The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI)
Time frame: 12 weeks
Age and Stages Questionnarie (ASQ)
Time frame: 12 weeks
Age and Stages Questionnaires: Social-Emotional (ASQ-SE)
Time frame: 12 weeks
Brief Infant and Toddler Social Emotional Assessment (BITSEA)
Time frame: 12 weeks
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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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?
A study testing The DIR/Floortime™ Therapy Program and The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program in people with Children with Developmental Risk, run by Biruni University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 24 Feb 2025. 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 Turkey (Türkiye). 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?
The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) (time frame: 12 weeks). The study lists 4 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 24 Feb 2025.