NCT07717853

Brief Summary

Autism spectrum disorder may affect children's participation in daily occupations through difficulties related to motor planning, problem-solving, attention, behavioral regulation, and sensory processing. The Cognitive Orientation to Daily Occupational Performance approach is a goal-oriented intervention that supports children in identifying and using cognitive strategies to improve the performance of personally meaningful activities. This pilot study aims to examine the preliminary effects of a 10-session Cognitive Orientation to Daily Occupational Performance intervention on occupational performance, satisfaction with performance, observed performance quality, and individualized goal attainment in primary school-aged children with autism spectrum disorder. Possible changes in autism-related behavioral characteristics and sensory processing patterns will also be examined.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress27%
Jul 2026Sep 2026

Study Start

First participant enrolled

July 10, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 16, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Autism Spectrum DisorderCognitive Orientation to Daily Occupational PerformanceOccupational Therapy

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure

    Satisfaction with performance for each prioritized activity is rated on a scale from 1 to 10, with higher scores indicating greater satisfaction. The mean satisfaction score will be calculated. Change will be determined by comparing baseline and post-intervention scores.

    Baseline and immediately after completion of the 10-session intervention

  • Performance Quality Rating Scale

    The Performance Quality Rating Scale is an observational measure used to rate the quality of performance of individualized activities. Performance is rated from 1 to 10, with higher scores indicating better performance quality. Each participant's selected occupational goals will be rated at baseline and after the intervention.

    Baseline and immediately after completion of the 10-session intervention

Secondary Outcomes (2)

  • Goal Attainment Scale

    Baseline and immediately after completion of the 10-session intervention

  • Childhood Autism Rating Scale

    Baseline and immediately after completion of the 10-session intervention

Study Arms (1)

CO-OP Intervention

EXPERIMENTAL

Participants will receive 10 individual sessions based on the Cognitive Orientation to Daily Occupational Performance approach. The intervention will focus on child- and family-identified daily occupational performance goals. Sessions will involve collaborative goal setting, dynamic performance analysis, guided discovery, cognitive strategy use, and the global strategy "Goal-Plan-Do-Check." Strategies will be practiced in relation to the selected activities, with emphasis on generalization and transfer to daily life.

Behavioral: Cognitive Orientation to Daily Occupational Performance Approach

Interventions

The Cognitive Orientation to Daily Occupational Performance approach is an individualized, goal-oriented intervention designed to improve the performance of meaningful daily activities through cognitive strategy use and guided discovery. Participants will complete 10 individual sessions, each lasting approximately 45 to 60 minutes. The intervention will target individualized occupational performance goals identified with the child and family. The global strategy "Goal-Plan-Do-Check" and task-specific strategies will be used to facilitate skill acquisition, problem-solving, generalization, and transfer.

Also known as: CO-OP Approach
CO-OP Intervention

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having a clinical diagnosis of autism spectrum disorder
  • Being of primary school age
  • Having communication and cooperation skills sufficient to participate in the - Cognitive Orientation to Daily Occupational Performance intervention
  • Having at least one daily occupational performance goal identified by the child and/or family
  • Being able to attend the assessment and intervention sessions regularly
  • Provision of written informed consent by a parent or legal guardian

You may not qualify if:

  • Having a severe neurological, orthopedic, or psychiatric condition that may substantially affect the assessment or intervention process
  • Having severe behavioral difficulties that prevent safe and consistent participation in the intervention sessions
  • Having participated in an intensive, structured cognitive strategy-based intervention program within the previous 6 months
  • Withdrawal of the child or parent/legal guardian from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlas University

Istanbul, Istanbul, 34762, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Zeynep Çorakcı Yazıcıoğlu

CONTACT

Ceren Davutoğlu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 21, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations