Effect of PLAY Project Intervention Program on Children With ASD
NCT ID: NCT05531669
Last Updated: 2022-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-08-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study group
the study group will receive 12 months of Play Project + Parental Education intervention
PLAY Project
PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction using videotape and written feedback within a developmental framework.
Parental Education
Each study center provides welcome course and parent guide for families with ASD children monthly.
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
PLAY Project
PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction using videotape and written feedback within a developmental framework.
Parental Education
Each study center provides welcome course and parent guide for families with ASD children monthly.
Interventions
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PLAY Project
PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction using videotape and written feedback within a developmental framework.
Parental Education
Each study center provides welcome course and parent guide for families with ASD children monthly.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Months
6 Years
ALL
No
Sponsors
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Fuzhou Children's Hospital of Fujian Medical University
UNKNOWN
Third Affiliated Hospital of Zhengzhou University
OTHER
Shenzhen Hospital of Southern Medical University
OTHER
Children's Hospital of Zhejiang University School of Medicine
UNKNOWN
Tongji Hospital
OTHER
Responsible Party
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Principal Investigators
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Yan Hao, doctor
Role: PRINCIPAL_INVESTIGATOR
Tongji Hospital
Locations
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Fuzhou Children's Hospital of Fujian Medical University
Fuzhou, Fujian, China
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Sanchack KE, Thomas CA. Autism Spectrum Disorder: Primary Care Principles. Am Fam Physician. 2016 Dec 15;94(12):972-979.
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.
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.
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.
Other Identifiers
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TJPLAY
Identifier Type: -
Identifier Source: org_study_id
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