NCT05106166

Brief Summary

In order to support the development of preschool children, joint attention training with activities incorporated in their natural routines can support the achievement of occupational therapy goals. This study explores the adjunctive benefit of a joint attention-based occupational therapy program offered in addition to the usual special education program (USEP) compared to USEP alone. The present study was designed as a randomized controlled study, including pre-post testing. The Social Communication Questionnaire (SCQ), Autism Behaviour Checklist (ABC), and A Motor-Free Visual Perception Test 4 (MVPT-4) were implemented to measure the participants' conditions before and after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

October 22, 2021

Last Update Submit

November 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Autistic Behavior Checklist (ABC)

    The ABC is among the scales used for screening and evaluating education in autism in many countries. The ABC consists of five sub-dimensions: sensory, relating, body or object use, language, and social and self-help. The total score is between 0-159. Minimum score is 159. Maximum score is 0.

    12 weeks

Secondary Outcomes (2)

  • Social Communication Questionnaire (SCQ)

    12 weeks

  • Motor-free Visual Perception Test-4 (MVPT-4)

    12 weeks

Study Arms (2)

Experimental group: occupational therapy program + the usual special education program (USEP)

EXPERIMENTAL

The practitioner used the less-to-more orientation to get the child to respond to the offer of joint attention. For example, if the child did not respond to the joint attention offer within 5-10 seconds, practitioner first directed the child, used exaggerated gestures, gave a moving hint if he still did not respond, and physically slowly directed the child's head towards the target if he still did not respond. In addition, the practitioner gave a verbal command (practitioner said: look at how his arms are waving, pointing to the toy, now look at me). When the child looked at the toy and reacted, he again gave enthusiastic and activity-appropriate feedback (e.g. he tickled the child, saying, "Isn't it weird, is there ever such a long arm?"). The child's interest and leadership in the activities were followed, including what the child did and said. Positive feedback was then provided.

Behavioral: Occupational Therapy

Control group: the usual special education program (USEP)

ACTIVE COMPARATOR

The USEP studied was including gross motor skills, communication skills, preschool preparation skills, and self-care skills. The control group of the study consisted of children attending the USEP.

Behavioral: Occupational Therapy

Interventions

occupational therapy sessions are based on the joint attention

Control group: the usual special education program (USEP)Experimental group: occupational therapy program + the usual special education program (USEP)

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosed with ASD
  • consenting to participate in the study.

You may not qualify if:

  • The study did not include children who had a co-morbid condition other than ASD
  • had no previous education or training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderCommunicationMental Disorders

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Sümeyye Belhan Çelik, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This prospective studies that measure the effectiveness of occupational therapy intervention. Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Participants are recruited and randomly assigned to either the intervention or the comparator group. It is important to ensure that at the time of recruitment there is no knowledge of which group the participant will be allocated to; this is known as concealment. It is examined whether there is any difference in the results of the study intervention and also the intervention and control group are compared.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 3, 2021

Study Start

April 1, 2020

Primary Completion

February 2, 2021

Study Completion

June 5, 2021

Last Updated

November 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

It is not planned to be shared to protect the privacy of the clients, but it can only be shared with the editor or the referee of the submitted journal if they want to see it.

Locations