NCT07740863

Brief Summary

Occupational Therapy Intervention in Children Diagnosed with Early and Late Autism Spectrum Disorder

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

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 Progress1%
Aug 2026Mar 2027

First Submitted

Initial submission to the registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 23, 2026

Last Update Submit

July 31, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Sociodemographic form

    age at diagnosis, weekly therapy frequency, total number of occupational therapy sessions, and sociodemographic data were recorded for all participants. All assessment forms were completed by caregivers during face-to-face interviews conducted before and after the intervention period.

    4 weeks

  • Sensory Processing Measure-Home (SPM-Home)

    The Sensory Processing Measure - Home Form (SPM-H) is a caregiver-reported questionnaire designed to evaluate sensory processing and related functional behaviors in children aged 5 to 12 years (Parham \& Ecker, 2007). The form consists of 75 items and is completed by parents or primary caregivers in approximately 15-20 minutes. The SPM-H assesses several sensory domains, including vision, hearing, touch, body awareness, and balance and motion. These subscales contribute to a total sensory score. In addition, the scale includes social participation and planning/ideas subscales, which reflect higher-order integrative functions influenced by sensory processing. Items are rated on a four-point frequency scale ranging from "never" to "always," with higher scores indicating greater sensory processing difficulties. Raw scores are converted into standardized T-scores, which are interpreted as typical performance, some problems, or definite dysfunction. The Turkish adaptation of the scale demon

    4 weeks

Secondary Outcomes (2)

  • Dunn Sensory Profile

    4 weeks

  • Executive Function Occupational Routine Scale (EFORTS)

    4 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

Occupational Therapy Group

Other: Occupational Therapy Intervention

Control Group

EXPERIMENTAL
Other: Occupational Therapy Intervention

Interventions

A pediatric occupational therapy intervention will be applied to improve children's performance and independence in daily living activities. The intervention will be structured according to the child's individual needs, functional capacity, developmental level, and difficulties in daily living activities. The intervention program will use activities aimed at supporting the child's performance in areas such as self-care, feeding, dressing, toileting, personal care, functional mobility, and participation in daily living routines. During the intervention process, the child's existing skills will be evaluated, and activities suitable for the child will be planned in line with activity analysis and a task-oriented approach. The intervention program will generally include the following components: Assessment of the child's performance in daily living activities Setting individual goals Activity analysis and activity-based intervention Working on self-care and daily living skills

Control GroupStudy Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • being between 6 and 12 years of age
  • having a formal diagnosis of ASD
  • actively attending occupational therapy sessions.

You may not qualify if:

  • Children with severe physical disabilities, significant visual or hearing impairments, or severe cognitive and communication limitations preventing participation in the assessment process were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Sedanur Gurlek

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 3, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

August 3, 2026

Record last verified: 2026-07