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A Multicenter Randomized Controlled Trial of the PLAY Game Intervention for Children with Autism Spectrum Disorder

A Multicenter Randomized Controlled Trial of the PLAY Game Intervention for Children with Autism Spectrum Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128759
Enrollment
Unknown
Registered
2026-07-24
Start date
2022-09-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autism spectrum disorder

Interventions

Intervention group:The PPC provides one-year PLAY intervention training for families in the intervention group: Families in the intervention group receive PLAY intervention training at each study cen
thereafter, one session per month, 3 hours per session. In addition, the PPC holds online Q&A sessions for families once a month, lasting 1 hour each time.
Control group:(1) Phase 1 (the first 6 months) Attend the online Parental Education courses . (2) Phase 2 (the latter 6 months) The PPC provides 6-month PLAY intervention training for families in the

Sponsors

Tongji Hospital, HUST Tongji Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1.5 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 months to 6 years, with no restriction on gender. 2. Children diagnosed with autism spectrum disorder (ASD) by professional physicians in hospital. All participants shall meet the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and yield positive results on the Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2). 3. Able to complete all child assessments including ADOS-2, DSM-5, Childhood Autism Rating Scale (CARS), Social Communication Questionnaire (SCQ) and Gesell Developmental Schedules (GDS), as well as parent assessments including Standard Progressive Matrices (SPM), Hamilton Depression Rating Scale (HAMD) and Parenting Stress Index-Short Form (PSI-SF). 4. Parents agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. High-functioning children with ASD: presenting only with impaired social communication while having well-developed language skills; the developmental quotient of the language domain on the Gesell Developmental Schedules is above 85. 2. Children diagnosed with any of the following conditions: a) Hereditary diseases, including Rett syndrome, fragile X syndrome, trisomy 21 and tuberous sclerosis; b) Visual or hearing impairment; c) Severe motor disorders such as cerebral palsy; d) Epilepsy. 3. Receiving or having received intensive interventions for more than 7 hours per week, such as Applied Behavior Analysis (ABA) and parent-based language training. 4. Parents with intellectual deficiency (standard score below the 25th percentile on Standard Progressive Matrices) or severe depression (total score > 24 on the 17-item Hamilton Depression Rating Scale).

Design outcomes

Primary

MeasureTime frame
Autism Diagnostic Observation Schedule, Second Edition;Childhood Autism Rating Scale;Social Communication Questionnaire;Diagnostic and Statistical Manual of Mental Disorders (DSM-5): Autism Diagnostic Assessment;

Secondary

MeasureTime frame
Gesell Developmental Schedules;Pivotal Behavior Rating Scale;Maternal Behavior Rating Scale;Hamilton Depression Rating Scale;Parenting Stress Index–Short Form;

Countries

China

Contacts

Public ContactHao Yan

Pediatrics, Tongji Hospital, HUST Tongji Medical College

haoyaner@163.com+86 135 1571 6081

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026