Back to resultsEffect of PLAY Project Intervention Program on Children With ASD
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PLAY Project
Parental Education
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, PLAY Project, functional developmental level
Eligibility Criteria
Inclusion Criteria:
- Age of 18 months to 6 years old at the time of enrollment, no gender requirement;
- 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).
- 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.
- Parents agreed to participate in the study provided written informed consent at recruitment.
Exclusion Criteria:
- High functioning ASD children with abnormal social communication but high language level. Language development quotient>85 in GDS;
Suffering from:
- hereditary diseases, such as Rett syndrome, Fragile X syndrome, trisomy 21 or tuberous sclerosis;
- abnormal vision or hearing impairment;
- movement disorders, such as cerebral palsy;
- epilepsy;
- Receive 7 hours or more per week of 1:1 intensive intervention, such as Applied Behavior Analysis (ABA), Parent-Implemented Language training, etc.
- Parents scoring <90 by SPM, or report being severely depressed by HAMD, will be excluded from the study.
Sites / Locations
- Fuzhou Children's Hospital of Fujian Medical UniversityRecruiting
- Shenzhen Hospital of Southern Medical UniversityRecruiting
- The Third Affiliated Hospital of Zhengzhou UniversityRecruiting
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyRecruiting
- Children's Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
control group
Arm Description
the study group will receive 12 months of Play Project + Parental Education intervention
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
Outcomes
Primary Outcome Measures
Changes in Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ) in ASD children
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.)
Changes in Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) in ASD children
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.
Changes in Child Autism Rating Scale (CARS) in ASD children
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.
Changes in Social Communication Questionnaire (SCQ) in ASD children
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.
Changes in Gesell Developmental Schedules (GDS) in ASD children
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).
Changes in Pivotal Behavior Rating Scale (PBRS) in ASD children
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).
Changes in Maternal Behavior Rating Scale (MBRS) in the interaction between ASD children and their parents
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.
Secondary Outcome Measures
Raven's Standard Progressive Matrices (SPM)
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.
Hamilton Depression Scale (HAMD)
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.
Changes in Parenting Stress Index-Short Form (PSI-SF) in parents of ASD children
Parenting stress is assessed using the PSI-SF, consists of 36 items.
Full Information
NCT ID
NCT05531669
First Posted
August 31, 2022
Last Updated
September 25, 2022
Sponsor
Tongji Hospital
Collaborators
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Fuzhou Children's Hospital of Fujian Medical University, Third Affiliated Hospital of Zhengzhou University, Shenzhen Hospital of Southern Medical University, Children's Hospital of Zhejiang University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05531669
Brief Title
Effect of PLAY Project Intervention Program on Children With ASD
Official Title
Effect of PLAY Project Intervention Program on Children With Autism Spectrum Disorder: A Multi-center, Randomized Control Study in China
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tongji Hospital
Collaborators
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Fuzhou Children's Hospital of Fujian Medical University, Third Affiliated Hospital of Zhengzhou University, Shenzhen Hospital of Southern Medical University, Children's Hospital of Zhejiang University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, PLAY Project, functional developmental level
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
the study group will receive 12 months of Play Project + Parental Education intervention
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
PLAY Project
Intervention Description
PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction using videotape and written feedback within a developmental framework.
Intervention Type
Behavioral
Intervention Name(s)
Parental Education
Intervention Description
Each study center provides welcome course and parent guide for families with ASD children monthly.
Primary Outcome Measure Information:
Title
Changes in Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ) in ASD children
Description
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.)
Time Frame
baseline, 6th-months, 12th-months
Title
Changes in Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) in ASD children
Description
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.
Time Frame
baseline, 6th-months, 12th-months
Title
Changes in Child Autism Rating Scale (CARS) in ASD children
Description
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.
Time Frame
baseline, 6th-months, 12th-months
Title
Changes in Social Communication Questionnaire (SCQ) in ASD children
Description
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.
Time Frame
baseline, 6th-months, 12th-months
Title
Changes in Gesell Developmental Schedules (GDS) in ASD children
Description
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).
Time Frame
baseline, 6th-months, 12th-months
Title
Changes in Pivotal Behavior Rating Scale (PBRS) in ASD children
Description
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).
Time Frame
baseline, 6th-months, 12th-months
Title
Changes in Maternal Behavior Rating Scale (MBRS) in the interaction between ASD children and their parents
Description
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.
Time Frame
baseline, 6th-months, 12th-months
Secondary Outcome Measure Information:
Title
Raven's Standard Progressive Matrices (SPM)
Description
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.
Time Frame
baseline
Title
Hamilton Depression Scale (HAMD)
Description
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.
Time Frame
baseline
Title
Changes in Parenting Stress Index-Short Form (PSI-SF) in parents of ASD children
Description
Parenting stress is assessed using the PSI-SF, consists of 36 items.
Time Frame
baseline, 6th-months, 12th-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 18 months to 6 years old at the time of enrollment, no gender requirement;
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).
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.
Parents agreed to participate in the study provided written informed consent at recruitment.
Exclusion Criteria:
High functioning ASD children with abnormal social communication but high language level. Language development quotient>85 in GDS;
Suffering from:
hereditary diseases, such as Rett syndrome, Fragile X syndrome, trisomy 21 or tuberous sclerosis;
abnormal vision or hearing impairment;
movement disorders, such as cerebral palsy;
epilepsy;
Receive 7 hours or more per week of 1:1 intensive intervention, such as Applied Behavior Analysis (ABA), Parent-Implemented Language training, etc.
Parents scoring <90 by SPM, or report being severely depressed by HAMD, will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Hu, doctor
Phone
15171469648
Email
huchen1992@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Hao, doctor
Organizational Affiliation
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuzhou Children's Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanxiong Lin
Phone
15305917542
Email
376661846@qq.com
Facility Name
Shenzhen Hospital of Southern Medical University
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lanfang Xie
Phone
18320638144
Email
1935223184@qq.com
Facility Name
The Third Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Wang
Phone
13674994719
Email
446243151@qq.com
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Hu, dodctor
Phone
15171469648
Email
huchen1992@126.com
Facility Name
Children's Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Jin
Phone
13819135963
Email
38994505@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of PLAY Project Intervention Program on Children With ASD
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