NCT07751679

Brief Summary

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by difficulties in social communication and interaction, as well as restricted and repetitive patterns of behavior. Children with ASD often experience challenges in developing social relationships and engaging in age-appropriate play activities. This study aims to evaluate the effectiveness of LEGO®-Based Play Therapy in improving social skills and play skills in children with autism spectrum disorder. Participants are assigned to either a LEGO®-Based Play Therapy group or a control group. The intervention consists of structured group sessions conducted over a 12-week period using collaborative LEGO® building activities designed to promote communication, cooperation, problem-solving, and peer interaction. The primary outcomes are changes in social skills and play skills measured using validated assessment tools before and after the intervention. The findings of this study may provide evidence regarding the effectiveness of LEGO®-Based Play Therapy as a supportive intervention for children with autism spectrum disorder and contribute to the development of evidence-based psychosocial interventions.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Aug 2026

Shorter than P25 for not_applicable

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 Progress5%
Aug 2026Jan 2027

First Submitted

Initial submission to the registry

July 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

July 31, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Autism Spectrum DisorderLEGO®-Based Play TherapySocial SkillsPlay SkillsChildrenPsychosocial InterventionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Play Skills

    Play skills will be assessed using the Penn Interactive Peer Play Scale (PIPPS)(parents and teacher scales). The Play Interaction subscale assesses positive social behaviors such as cooperation, sharing, helping, and inviting peers to join play activities. The Play Disruption subscale measures aggressive, antisocial, and conflict-provoking behaviors, whereas the Play Disconnection subscale evaluates the child's tendency to withdraw from peer play and exhibit socially withdrawn behaviors. All items are rated on a 4-point Likert scale. The Turkish adaptation, validity, and reliability study of the scale was conducted by Ahmetoğlu et al. (2016). The findings demonstrated that the original three-factor structure of the scale was retained. The Cronbach's alpha coefficients were reported as 0.72 for the Play Interaction subscale, 0.75 for the Play Disruption subscale, and 0.68 for the Play Disconnection subscale. In the present study, the scale was administered at pre-test, post-test, and

    Baseline, Week 12 (post-intervention), and Week 24 (12-week follow-up)

  • Social Skills

    Social skills will be assessed using the Autism Social Skills Profile (ASSP). Higher scores indicate better social skills. The Autism Social Skills Profile (ASSP) consists of 41 items organized into three subscales: Social Reciprocity, Social Participation, and Detrimental Social Behaviors. The questionnaire is completed by parents using a 4-point Likert scale ranging from 0 (Never) to 3 (Very Often). Total scores range from 0 to 123, with higher scores indicating more advanced social skills. The Turkish adaptation, validity, and reliability study of the parent version of the ASSP was conducted by Demir (2014). The findings demonstrated excellent internal consistency, with a Cronbach's alpha coefficient of 0.92. In the present study, the ASSP was administered at pre-test, post-test, and follow-up to evaluate the effects of LEGO®-based group play therapy on the social skills of children. Permission to use the scale was obtained prior to data collection.

    Baseline, Week 12 (immediately after completion of the intervention), and Week 24 (12 weeks after completion of the intervention)

Study Arms (2)

LEGO®-Based Play Therapy Group

EXPERIMENTAL

Structured LEGO®-Based Play Therapy delivered in small groups over a 12-week period to improve social and play skills in children with autism spectrum disorder.

Behavioral: LEGO®-Based Play Therapy

Control Group

NO INTERVENTION

Participants receive no LEGO®-Based Play Therapy during the study period and continue with their usual care or routine educational activities.

Interventions

Participants receive LEGO®-Based Play Therapy in small groups once weekly for 12 weeks. During each session, children collaboratively build LEGO® models while rotating through three structured roles: Engineer (provides building instructions and guides the task), Supplier (identifies and provides the required LEGO® pieces), and Builder (assembles the LEGO® model according to the instructions). The intervention is designed to improve social communication, cooperation, joint attention, problem-solving, and play skills through structured peer interaction.

LEGO®-Based Play Therapy Group

Eligibility Criteria

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

You may qualify if:

  • Children aged 6 to 12 years.
  • Diagnosis of Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or the International Classification of Diseases, 11th Revision (ICD-11).
  • Regular attendance at the Istanbul Gedik University Center for Barrier-Free Life Practice and Research.
  • No physical health condition that would prevent participation in group activities.
  • Written informed consent obtained from a parent or legal guardian.
  • Willingness of the child to participate in the study.

You may not qualify if:

  • Presence of a physical, neurological, or psychiatric condition that would prevent participation in LEGO®-Based Group Play Therapy.
  • Absence from more than 20% of the planned 12 intervention sessions. Incomplete completion of the data collection instruments by the parent or legal guardian, or failure to participate in the post-intervention or follow-up assessments.
  • Withdrawal from the study by the child or the parent/legal guardian at any stage of the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Gedik University Center for Barrier-Free Life Practice and Research

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderSocial Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Yeter Çuvadar Baş, MsC

    Marmara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeter Çuvadar Baş, Msc /PhD Canditate

CONTACT

Semra Karaca, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either the LEGO®-Based Play Therapy intervention group or the control group in a parallel-group design. The intervention group receives LEGO®-Based Play Therapy in small groups over a 12-week period, while the control group does not receive LEGO®-Based Play Therapy during the study period. Outcomes are assessed at baseline, immediately after completion of the 12-week intervention, and at a 12-week follow-up assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD Student

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 7, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because no data-sharing plan was included in the study protocol or participant consent documents. Participant confidentiality and privacy will be protected in accordance with institutional ethical requirements.

Locations