NCT07656961

Brief Summary

The aim of the study is to investigate the long-term effects of ASI-based and hybrid neurodevelopmental counseling services on the variables of the Ayres Sensory Integration Assessment Test in children with neurodevelopmental disorders.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress21%
Jun 2026Jan 2027

First Submitted

Initial submission to the registry

June 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 18, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2027

Expected
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

28 days

First QC Date

June 15, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

Neurodevelopmental DisordersSensory IntegrationEASI

Outcome Measures

Primary Outcomes (2)

  • The Evaluation of Ayres Sensory Integration (EASI)

    The Evaluation of Ayres Sensory Intergation test measures sensory perception, postural/ocular/bilateral motor integration, praxis, and sensory reactivity in a way that minimizes the effects of culture, language comprehension, and prior experience. The EASI tests are designed for children aged 3-12 and will be administered by appropriately trained professionals.

    4 Weeks

  • Pediatric Sensory Profile

    This is a measure consisting of three main sections used in children. These are; sensory processing, modulation and behavioral and emotional responses. The subgroups of each main section (14 sections in total, 125 questions) are tested. This scale is administered by the caregiver.

    4 weeks

Study Arms (1)

Children With Neurodevelopmental Disorders

Children aged 3 to 12 years with neurodevelopmental disorders who applied to the YUGEM Sensory Perception Motor Unit and are considered suitable for the Evaluation in Ayres Sensory Integration assessment.

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of children aged 3 to 12 years with diagnosed or suspected neurodevelopmental problems who apply to the YUGEM Sensory Perception Motor Unit at Yeditepe University. Children referred for neurodevelopmental follow-up and considered suitable for the Evaluation in Ayres Sensory Integration assessment will be included in the study.

You may qualify if:

  • Aged 3-12
  • Sensory sensitivity (excessive or under-reaction to tactile, movement, auditory, or visual stimuli)
  • Have been referred by a pediatrician for neurodevelopmental monitoring
  • Have coordination difficulties
  • Difficulty organizing gross and/or fine motor movements
  • Activity level significantly above or below the norm for their age
  • Delays in academic achievement
  • Difficulties with daily living skills such as dressing and personal hygiene

You may not qualify if:

  • Being under 3 years of age or over 12 years of age
  • Having no conditions that fall outside normal developmental parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir, 34755, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Elif Develi, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 18, 2026

Study Start

June 18, 2026

Primary Completion

July 16, 2026

Study Completion (Estimated)

January 16, 2027

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations