Effect of PLAY Project Intervention Program on Children With ASD

September 25, 2022 updated by: Tongji Hospital

Effect of PLAY Project Intervention Program on Children With Autism Spectrum Disorder: A Multi-center, Randomized Control Study in China

The objective of this study is to evaluate the effectiveness of the Play and Language for Autistic Youngsters (PLAY) Project Home Consultation model to improve parent-child interaction, child development, and autism symptomatology in young children with autism spectrum disorders (ASDs) in China.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The present multi-center randomized controlled trial will recruit 200 children with ASD aged 18 months to 6 years from 5 hospitals including Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Fuzhou Children's Hospital of Fujian Medical University, The Third Affiliated Hospital of Zhengzhou University, Shenzhen Hospital of Southern Medical University and Children's Hospital of Zhejiang University School of Medicine from 2022.8 to 2023.1.Children who meet the inclusion criteria will be stratified by ASD severity, age and gender and randomly assigned (1:1) to either study group or control group. Using the waitlist-control group design, the study group will receive 12 months of Play Project + Parental Education intervention, the control group receive Parental Education intervention in the first 6 months, and then receive Play Project + Parental Education intervention in the next 6 months. Pre-, 6th month and post- assessments for both groups will be conducted, including Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ), Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), Social Communication Questionnaire (SCQ), Child Autism Rating Scale (CARS), Gesell Developmental Schedules (GDS) for children; Raven's Standard Progressive Matrices (SPM), Hamilton Depression Scale (HAMD) and Parenting Stress Index-Short Form (PSI-SF) for parents, Maternal Behavior Rating Scale (MBRS) and Pivotal Behavior Rating Scale (PBRS).

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350004
        • Recruiting
        • Fuzhou Children's Hospital of Fujian Medical University
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518100
        • Recruiting
        • Shenzhen Hospital of Southern Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The Third Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Children's Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age of 18 months to 6 years old at the time of enrollment, no gender requirement;
  2. Children who were diagnosed with autism spectrum disorder in 5 research centers, meet the diagnostic criteria by Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ), and the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2).
  3. Complete pre-assessments in outpatient clinics, including: Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ), Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), Social Communication Questionnaire (SCQ), Child Autism Rating Scale (CARS), Gesell Developmental Schedules (GDS) for children; Raven's Standard Progressive Matrices (SPM), Hamilton Depression Scale (HAMD) and Parenting Stress Index-Short Form (PSI-SF) for parents.
  4. Parents agreed to participate in the study provided written informed consent at recruitment.

Exclusion Criteria:

  1. High functioning ASD children with abnormal social communication but high language level. Language development quotient>85 in GDS;

  2. Suffering from:

    1. hereditary diseases, such as Rett syndrome, Fragile X syndrome, trisomy 21 or tuberous sclerosis;
    2. abnormal vision or hearing impairment;
    3. movement disorders, such as cerebral palsy;
    4. epilepsy;
  3. Receive 7 hours or more per week of 1:1 intensive intervention, such as Applied Behavior Analysis (ABA), Parent-Implemented Language training, etc.
  4. Parents scoring <90 by SPM, or report being severely depressed by HAMD, will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
the study group will receive 12 months of Play Project + Parental Education intervention
Behavioral: PLAY Project
PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction using videotape and written feedback within a developmental framework.
Behavioral: Parental Education
Each study center provides welcome course and parent guide for families with ASD children monthly.
Active Comparator: control group
the control group will receive Parental Education intervention in the first 6 months, and then receive Play Project + Parental Education intervention in the next 6 months
Behavioral: PLAY Project
PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction using videotape and written feedback within a developmental framework.
Behavioral: Parental Education
Each study center provides welcome course and parent guide for families with ASD children monthly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ) in ASD children
Time Frame: baseline, 6th-months, 12th-months
DSM-5 provides core symptom domain severity levels based on the level of support needed for individual functioning, in addition to specifiers which offer descriptions of common co-occurring non-ASD impairments (i.e., intellectual impairments, language deficits, medical and psychiatric conditions, etc.)
baseline, 6th-months, 12th-months
Changes in Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) in ASD children
Time Frame: baseline, 6th-months, 12th-months
ADOS-2 is a standardized diagnostic instrument designed to assess communication, social interaction, play skills, and restrictive and repetitive behaviors (RRB). The ADOS-2 can be used with individuals at a wide range of developmental and language levels: Module 1 for use with children who do not consistently use phrase speech; Module 2 for children who use phrase speech, but are not verbally fluent; Module 3 for verbally fluent children and young adolescents; and Module 4 for verbally fluent older adolescents and adults. The calibrated severity scores (CSS) have been created for Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2), Modules 1-4 as a metric of the relative severity of autism-specific behaviors.
baseline, 6th-months, 12th-months
Changes in Child Autism Rating Scale (CARS) in ASD children
Time Frame: baseline, 6th-months, 12th-months
CARS assesses the child on a scale from 1 to 4 in each of 15 dimensions or symptoms. A total score of at least 30 strongly suggests the presence of autism. Children with score between 30 and 36 have mild-to-moderate autism while those with score between 37 and 60 have severe autism.
baseline, 6th-months, 12th-months
Changes in Social Communication Questionnaire (SCQ) in ASD children
Time Frame: baseline, 6th-months, 12th-months
The Social Communication Questionnaire (SCQ) is one of the standardized screening tools used to identify ASD. It contains 40 questions about reciprocal social interaction, communication, and repetitive/stereotypic behavior. Each yes/no item (scored as 1 or 0, respectively) indicates the presence or absence of developmentally inappropriate behaviors. Scores range between 0 and 33 for individuals without verbal speech and from 0 to 39 for verbal individuals. In addition, higher scores indicate more worrisome behaviors, and a cutoff score of ≥15 points is established as indicating a risk of ASD.
baseline, 6th-months, 12th-months
Changes in Gesell Developmental Schedules (GDS) in ASD children
Time Frame: baseline, 6th-months, 12th-months
Developmental and language assessment，A subscale DQ less than 76 points indicates a developmental delay, a quotient between 76 and 85 points is slightly below the threshold for developmental delay, and a quotient greater than or equal to 86 points indicates normal development. Performance in each area was recorded as an equivalent developmental age in months. Developmental quotients were calculated by comparing the children's performance equivalent age and their chronological age at the time of administration (DQ=developmental age / chronological age x 100).
baseline, 6th-months, 12th-months
Changes in Pivotal Behavior Rating Scale (PBRS) in ASD children
Time Frame: baseline, 6th-months, 12th-months
The PBRS is a key outcome measure of contingent, reciprocal, social interactions. PBRS measures two components of interactive behavior - Attention and Initiation. The child's primary caregiver is asked to play with the child for 7 ½ minutes using a standard set of toys. Independent raters, blind to subject status, review a videotape of the session and score the child's behavior on seven items: attention to activity; persistence (practice/problem solving); involvement (vs. distractibility); cooperation; initiate activities; joint attention; and affect (emotional state during play).
baseline, 6th-months, 12th-months
Changes in Maternal Behavior Rating Scale (MBRS) in the interaction between ASD children and their parents
Time Frame: baseline, 6th-months, 12th-months
MBRS is a video rating scale that assesses four Interactive Style Factors including: Responsive/Child Oriented; Affect/Animation; Achievement Orientation; and Directiveness (Aim 1, Outcomes 1-3). Factors are assessed by rating twelve (5 point Likert-scaled) items during a 7 ½ minute video of typical parent-child play with toys.
baseline, 6th-months, 12th-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Raven's Standard Progressive Matrices (SPM)
Time Frame: baseline
SPM is an intelligence quotient(IQ) screen to ensure that parents have the cognitive/verbal skills to properly translate information into action. Parents scoring less than 90 will be excluded from the study.
baseline
Hamilton Depression Scale (HAMD)
Time Frame: baseline
HAMD assesses whether parents have the emotional functionality needed to deliver the intervention. Parents who report being severely depressed will be excluded from the study.
baseline
Changes in Parenting Stress Index-Short Form (PSI-SF) in parents of ASD children
Time Frame: baseline, 6th-months, 12th-months
Parenting stress is assessed using the PSI-SF, consists of 36 items.
baseline, 6th-months, 12th-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Collaborators

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Third Affiliated Hospital of Zhengzhou University
Shenzhen Hospital of Southern Medical University
Fuzhou Children's Hospital of Fujian Medical University
Children's Hospital of Zhejiang University School of Medicine

Investigators

  • Principal Investigator: Yan Hao, doctor, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJPLAY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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