NCT07121231

Brief Summary

This mixed-method study evaluated the effects of a 12-week Motor Support Program (MSP) on the multidimensional development of children with autism aged 4-6. The program targeted motor skills, social skills, pre-academic abilities, sensory regulation, and autism-specific symptoms. A total of 30 children diagnosed with autism from four special education and rehabilitation centers in Istanbul were randomly assigned to experimental (n = 15) and control (n = 15) groups. Quantitative data were collected using a pretest-posttest control group design: motor skills were measured with BOT-2, social skills with SSRS-PTF, pre-academic skills with PASAF, autism symptoms with the Adapted Autism Behavior Checklist, and sensory processing with the Sensory Profile. Qualitative data were obtained through semi-structured focus group interviews with parents, each lasting approximately 30 minutes. The interview questions were developed by the researchers and finalized based on expert feedback.

Trial Health

87
On Track

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
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

July 1, 2025

Enrollment Period

29 days

First QC Date

July 23, 2025

Last Update Submit

August 8, 2025

Conditions

Keywords

Motor support programAtistic childrenMotor skillsSocial skillsPre-academic skillsSensory motor skills

Outcome Measures

Primary Outcomes (3)

  • Change in Social Skills as Measured by the Social Skills Assessment System - Preschool Teacher Form (SSRS-PTF)

    This scale is a behavioral assessment tool that can be applied to children aged 3-18. The form, which is structured for the preschool period, consists of a total of 40 items and two subscales. The first 30 items assess social skills such as cooperation, taking responsibility, and self-regulation, while items 31-40 measure problem behaviors such as aggression, stubbornness, and noncompliance with rules. The scale is evaluated using a three-point Likert-type scoring system for each item: "never" (0), 'sometimes' (1), and "very often" (2). The maximum score that can be obtained on the Social Skills subscale is 90, with higher scores indicating more developed social skills in the child. The maximum score that can be obtained on the Problem Behaviors subscale is 30, and a score closer to zero indicates that problem behaviors are less frequent.

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest), and 12 weeks after the completion of the intervention (follow-up test).

  • Change in Motor Skills as Measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Short Form (BOT-2 SF)"

    In this study, the short form of the Bruininks-Oseretsky Motor Competence Test-2 (BOT-2 SF), which was developed to assess the motor skill levels of individuals aged 4-21 years, was used. The short form used in the study consists of a total of eight subtests and 12 items. These subtests include fine motor accuracy, fine motor integration, manual agility, two-way coordination, balance, running speed and agility, hand-arm coordination and strength. The maximum score that can be obtained in the test is 50. As the total score increases, the level of motor skills increases.

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest), and 12 weeks after the completion of the intervention (follow-up test).

  • Change in Pre-Academic Skills as measured by Pre-Academic Skills Assessment Form

    The Pre-Academic Skills Assessment Form (PASAF) developed by Özcan (2022) is an assessment form that can be applied to typically developing children and children with special needs between the ages of 3 and 6. The basic concepts determined in line with the goals of preschool education are grouped under the headings of color, geometric shape, size and number, and the form consists of 4 subtests and a total of 34 items. The scoring criteria of PASAF are based on scoring each item as 1 (one) or 0 (zero). A score of 1 indicates that the child responded correctly to the relevant item, while a score of 0 indicates that the child responded incorrectly or did not respond. As the total score increases, the level of prior academic skills improves.

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest), and 12 weeks after the completion of the intervention (follow-up test).

Secondary Outcomes (2)

  • Adapted Autism Behavior Checklist to assess symptoms related to autism

    Evaluations were conducted at two time points: at baseline (pretest), at the end of the 12-week intervention (posttest).

  • Sensory profile questionnaire to assess sensory motor skills

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest), and 12 weeks after the completion of the intervention (follow-up test).

Study Arms (2)

Motor Support Program

EXPERIMENTAL

Participants in this group completed a motor skills support program designed with a holistic approach to support cognitive development through concepts such as color, shape, and number, as well as social skills such as greeting, lining up, and cooperation, through activities based on basic motor skills such as throwing, catching, running, and jumping.

Other: Motor Support Program

Standard Education (No Motor Support)

NO INTERVENTION

Participants in the control group continued their individual education programs. However, they did not participate in any physiotherapy or motor support programs. Only pre- and post-test measurements were taken.

Interventions

The MSP was implemented over 12 weeks, two days a week, 50 minutes per session. Based on pre-test results, 30% (15 minutes) of each session was devoted to individualized activities, and 70% (35 minutes) to group activities supporting peer interaction. This structure allowed for both personalized support and social engagement. The program was carried out by the research team and eight special education teachers at the children's rehabilitation centers. Each child received one-on-one support from at least one teacher. Activities were aligned with preschool motor development goals and followed a four-phase structure: (1) Warm-up (5 min): rhythmic movements (e.g., walking, running, jumping); (2) Preparation (5 min): functional exercises for flexibility and joint mobility; (3) Main activity (35 min): individual and group exercises to enhance motor, social, and pre-academic skills; (4) Cool-down (5 min): group games reinforcing learned skills and social interaction.

Motor Support Program

Eligibility Criteria

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

You may qualify if:

  • Participants were between the ages of 4 and 6.
  • Had been diagnosed with autism.
  • Had not participated in any Motor Skills Program (MSP) before.
  • Did not have any health problems that would prevent MSP implementation.
  • Did not have secondary diagnoses, such as visual or hearing impairment.

You may not qualify if:

  • Detection of a health problem that prevented children in the experimental group from participating in the MSP.
  • Non-participation in the assessment tests by participants in either the experimental or control group.
  • Voluntary withdrawal from the training or measurement process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpaşa

Istanbul, Istanbul, 34320, Turkey (Türkiye)

Location

Related Publications (4)

  • Aykır A, Tekinarslan İ. C. Adaptation of the Social Skills Rating System (SBDS) preschool teacher form into Turkish: A validity and reliability study. Education and Science. 2012; 37(165): 3-17.

    BACKGROUND
  • Kayıhan H, Günel M. K, Bumin G. Adaptation of the Sensory Profile into Turkish for children aged 3-10 years: A validity and reliability study. Turkish Journal of Physiotherapy and Rehabilitation. 2011; 22(2): 44-53.

    BACKGROUND
  • Özcan G. H. Otizm Spektrum Bozukluğu Tanısı Almış Çocuklarda Hareket Eğitimi Programının Akademik Beceriler, Motor Beceriler ve Sosyal İletişim Becerileri Üzerindeki Etkisinin İncelenmesi (PhD thesis) İstanbul: Marmara University; 2022.

    BACKGROUND
  • Krug DA, Arick J, Almond P. Behavior checklist for identifying severely handicapped individuals with high levels of autistic behavior. J Child Psychol Psychiatry. 1980 Jul;21(3):221-9. doi: 10.1111/j.1469-7610.1980.tb01797.x. No abstract available.

    PMID: 7430288BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderSocial Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This mixed-method study evaluated the effects of a 12-week Motor Support Program (MSP) on the multidimensional development of children with autism aged 4-6. The program targeted motor skills, social skills, pre-academic abilities, sensory regulation, and autism-specific symptoms. A total of 30 children diagnosed with autism from four special education and rehabilitation centers in Istanbul were randomly assigned to experimental (n = 15) and control (n = 15) groups. Quantitative data were collected using a pretest-posttest control group design: motor skills were measured with BOT-2, social skills with SSRS-PTF, pre-academic skills with PASAF, autism symptoms with the Adapted Autism Behavior Checklist, and sensory processing with the Sensory Profile. Qualitative data were obtained through semi-structured focus group interviews with parents, each lasting approximately 30 minutes. The interview questions were developed by the researchers and finalized based on expert feedback.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 13, 2025

Study Start

January 8, 2024

Primary Completion

February 6, 2024

Study Completion

September 3, 2024

Last Updated

August 13, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations