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Autism Spectrum DisorderNCT05531669

Effect of PLAY Project Intervention Program on Children With ASD

A study testing PLAY Project and Parental Education in people with Autism Spectrum Disorder, run by Tongji Hospital at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 months to 6 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
PLAY Project and Parental Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
5 sitesChina
Study dates
1 Aug 2022to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

Chen Hu, doctor contact

15171469648

huchen1992@126.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Fuzhou Children's Hospital of Fujian Medical University

    Fuzhou, Fujian, 350004

    Guanxiong Lin, 15305917542, 376661846@qq.com

    Recruiting

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Yan Jin, 13819135963, 38994505@qq.com

    Recruiting

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong, 518100

    Lanfang Xie, 18320638144, 1935223184@qq.com

    Recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

    Chen Hu, dodctor, 15171469648, huchen1992@126.com

    Recruiting

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Ji Wang, 13674994719, 446243151@qq.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
PLAY Project, Parental Education
Keywords
Autism Spectrum Disorder, PLAY Project, functional developmental level
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLAY ProjectBehavioural

    PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction using videotape and written feedback within a developmental framework.

  • Parental EducationBehavioural

    Each study center provides welcome course and parent guide for families with ASD children monthly.

Study groups in NCT05531669
Study groupRoleWhat they receive
Study groupExperimentalthe study group will receive 12 months of Play Project + Parental Education intervention
Receives: Behavioral: PLAY Project; Behavioral: Parental Education
control groupActive comparatorthe 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
Receives: Behavioral: PLAY Project; Behavioral: Parental Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: baseline, 6th-months, 12th-months

  2. 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.

    Measured: baseline, 6th-months, 12th-months

  3. 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.

    Measured: baseline, 6th-months, 12th-months

  4. 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.

    Measured: baseline, 6th-months, 12th-months

  5. 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).

    Measured: baseline, 6th-months, 12th-months

  6. 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).

    Measured: baseline, 6th-months, 12th-months

  7. 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.

    Measured: baseline, 6th-months, 12th-months

Secondary outcomes (3)

  1. 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.

    Measured: baseline

  2. 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.

    Measured: baseline

  3. 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.

    Measured: baseline, 6th-months, 12th-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531669
Sponsor's protocol ID
TJPLAY
Status last verified
Aug 2022
First submitted
31 Aug 2022
Last updated
27 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hyman SL, Levy SE, Myers SM; COUNCIL ON CHILDREN WITH DISABILITIES, SECTION ON DEVELOPMENTAL AND BEHAVIORAL PEDIATRICS. Identification, Evaluation, and Management of Children With Autism Spectrum Disorder. Pediatrics. 2020 Jan;145(1):e20193447. doi: 10.1542/peds.2019-3447. Epub 2019 Dec 16.

    PubMed 31843864

  • Gnanavel S, Robert RS. Diagnostic and statistical manual of mental disorders, fifth edition, and the impact of events scale-revised. Chest. 2013 Dec;144(6):1974. doi: 10.1378/chest.13-1691. No abstract available.

    PubMed 24297138

  • Lord C, Charman T, Havdahl A, Carbone P, Anagnostou E, Boyd B, Carr T, de Vries PJ, Dissanayake C, Divan G, Freitag CM, Gotelli MM, Kasari C, Knapp M, Mundy P, Plank A, Scahill L, Servili C, Shattuck P, Simonoff E, Singer AT, Slonims V, Wang PP, Ysrraelit MC, Jellett R, Pickles A, Cusack J, Howlin P, Szatmari P, Holbrook A, Toolan C, McCauley JB. The Lancet Commission on the future of care and clinical research in autism. Lancet. 2022 Jan 15;399(10321):271-334. doi: 10.1016/S0140-6736(21)01541-5. Epub 2021 Dec 6. No abstract available.

    PubMed 34883054

  • Maenner MJ, Shaw KA, Bakian AV, Bilder DA, Durkin MS, Esler A, Furnier SM, Hallas L, Hall-Lande J, Hudson A, Hughes MM, Patrick M, Pierce K, Poynter JN, Salinas A, Shenouda J, Vehorn A, Warren Z, Constantino JN, DiRienzo M, Fitzgerald RT, Grzybowski A, Spivey MH, Pettygrove S, Zahorodny W, Ali A, Andrews JG, Baroud T, Gutierrez J, Hewitt A, Lee LC, Lopez M, Mancilla KC, McArthur D, Schwenk YD, Washington A, Williams S, Cogswell ME. Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2018. MMWR Surveill Summ. 2021 Dec 3;70(11):1-16. doi: 10.15585/mmwr.ss7011a1.

    PubMed 34855725

  • Zhou H, Xu X, Yan W, Zou X, Wu L, Luo X, Li T, Huang Y, Guan H, Chen X, Mao M, Xia K, Zhang L, Li E, Ge X, Zhang L, Li C, Zhang X, Zhou Y, Ding D, Shih A, Fombonne E, Zheng Y, Han J, Sun Z, Jiang YH, Wang Y; LATENT-NHC Study Team. Prevalence of Autism Spectrum Disorder in China: A Nationwide Multi-center Population-based Study Among Children Aged 6 to 12 Years. Neurosci Bull. 2020 Sep;36(9):961-971. doi: 10.1007/s12264-020-00530-6. Epub 2020 Jun 30.

    PubMed 32607739

  • Magiati I, Tay X W, Howlin P. Early comprehensive behaviorally based interventions for children with autism spectrum disorders: a summary of findings from recent reviews and meta-analyses [J]. Neuropsychiatry, 2012, 2(6): 543-570.

  • Rogge N, Janssen J. The Economic Costs of Autism Spectrum Disorder: A Literature Review. J Autism Dev Disord. 2019 Jul;49(7):2873-2900. doi: 10.1007/s10803-019-04014-z.

    PubMed 30976961

  • Kodak T, Bergmann S. Autism Spectrum Disorder: Characteristics, Associated Behaviors, and Early Intervention. Pediatr Clin North Am. 2020 Jun;67(3):525-535. doi: 10.1016/j.pcl.2020.02.007. Epub 2020 May 4.

    PubMed 32443991

  • Sanchack KE, Thomas CA. Autism Spectrum Disorder: Primary Care Principles. Am Fam Physician. 2016 Dec 15;94(12):972-979.

    PubMed 28075089

  • Solomon R, Van Egeren LA, Mahoney G, Quon Huber MS, Zimmerman P. PLAY Project Home Consultation intervention program for young children with autism spectrum disorders: a randomized controlled trial. J Dev Behav Pediatr. 2014 Oct;35(8):475-85. doi: 10.1097/DBP.0000000000000096.

    PubMed 25264862

  • Oono IP, Honey EJ, McConachie H. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD009774. doi: 10.1002/14651858.CD009774.pub2.

    PubMed 23633377

  • Hume K, Steinbrenner JR, Odom SL, Morin KL, Nowell SW, Tomaszewski B, Szendrey S, McIntyre NS, Yucesoy-Ozkan S, Savage MN. Evidence-Based Practices for Children, Youth, and Young Adults with Autism: Third Generation Review. J Autism Dev Disord. 2021 Nov;51(11):4013-4032. doi: 10.1007/s10803-020-04844-2. Epub 2021 Jan 15.

    PubMed 33449225

Questions about this trial

What is this clinical trial studying?

A study testing PLAY Project and Parental Education in people with Autism Spectrum Disorder, run by Tongji Hospital at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chen Hu, doctor (15171469648, huchen1992@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ) in ASD children (time frame: baseline, 6th-months, 12th-months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05531669, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.

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