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Parent Skills Training for Families of Children With Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT03864289
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE March 6, 2019
Last Update Posted Date March 8, 2019
Estimated Study Start Date  ICMJE March 15, 2019
Estimated Primary Completion Date January 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
  • Change from baseline average score of the Interaction Fidelity Rating System at 8 weeks [ Time Frame: From enrollment to end of training(8 week). The score will be measured at the following time point: enrollment,end of training. ]
    The Interaction Fidelity Rating System is used to evaluate the quality of the parent mastery of intervention skills and the quality of interaction. It's a 5-point rating system (1-5) of 11 items. Parent fidelity is rated from the parent-child interaction videos by trainers. The investigators take the average score of the 11 items as a result. The highest score is 5 and the lowest is 1. The higher the score is, the better intervention skills the parents had. The 5-point rating system: 1 - the strategy is not demonstrated or inappropriately applied. 2- the strategy is used somewhat appropriately at times. 3 - appropriate and accurate implementation of the strategy occurs up to 50% of the time. 4 - appropriate and accurate implementation of the strategy occurs up to 80% of the time. 5- Strategies are applied appropriately in 80-100% of opportunities.
  • Change from baseline correct answer rate of the Questionnaire on Awareness and Knowledge of Interventions about Autism at 8 weeks [ Time Frame: From enrollment to end of training(8 week). The correct rate will be measured at the following time point: enrollment, end of training. ]
    The Questionnaire on Awareness and Knowledge of Interventions about Autism includes 11 questions. Parents filled in the questionnaire. The investigators take the correct rate as a result. If all the 11 questions were answered correctly, the correct rate would be 100%. The highest correct rate is 100% and the lowest is 0%.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • Change from baseline average score of the Interaction Fidelity Rating System at 8 weeks [ Time Frame: From enrollment to end of training(8 week). The score will be measured at the following time point: enrollment,end of training. ]
    The Interaction Fidelity Rating System is used to evaluate the quality of the parent mastery of intervention skills and the quality of interaction. It's a 5-point rating system (1-5) of 11 items. Parent fidelity is rated from the parent-child interaction videos by trainers. We take the average score of the 11 items as a result. The highest score is 5 and the lowest is 1. The higher the score is, the better intervention skills the parents had. The 5-point rating system: 1 - the strategy is not demonstrated or inappropriately applied. 2- the strategy is used somewhat appropriately at times. 3 - appropriate and accurate implementation of the strategy occurs up to 50% of the time. 4 - appropriate and accurate implementation of the strategy occurs up to 80% of the time. 5- Strategies are applied appropriately in 80-100% of opportunities.
  • Change from baseline correct answer rate of the Questionnaire on Awareness and Knowledge of Interventions about Autism at 8 weeks [ Time Frame: From enrollment to end of training(8 week). The correct rate will be measured at the following time point: enrollment, end of training. ]
    The Questionnaire on Awareness and Knowledge of Interventions about Autism includes 11 questions. Parents filled in the questionnaire. We take the correct rate as a result. If all the 11 questions were answered correctly, the correct rate would be 100%. The highest correct rate is 100% and the lowest is 0%.
Change History Complete list of historical versions of study NCT03864289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parent Skills Training for Families of Children With Autism Spectrum Disorder
Official Title  ICMJE Parent Skills Training for Families of Children With Autism Spectrum Disorder
Brief Summary The study is focused on helping parents master the basic intervention skills and evaluate the effectiveness of this parental training style for children with autism spectrum disorder in China.
Detailed Description

The investigators designed a set of parental training curriculum about early intervention.

The curriculum consists of three units: (1) Delivery of theoretical intervention knowledge and analysis of successful training cases; (2) Commenting and making suggestion on parent-child interaction videos; (3) Demonstration of intervention skills and practice .The contents of the curriculum involved setting up an environment, developing objectives (verbal communication, non-verbal communication, social interaction, imitation, fine motor skills, etc.), designing activities, dealing with challenging behavior. This study will help parents master the basic intervention skills(how to set up an environment, develop objectives, design activities, deal with challenging behavior, etc) . At last the investigators will evaluate the effectiveness of this parental training style for children with autism spectrum disorder in China.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE Behavioral: Parent skills training
Parents of children with autism spectrum disorder attend the parental training course once a week, and there was a total of eight courses with each course lasting 3 hours
Other Name: PST
Study Arms  ICMJE Experimental: Parent skills training
Parents of children with autism spectrum disorder attend the parental training course once a week, and there was a total of eight courses with each course lasting 3 hours.
Intervention: Behavioral: Parent skills training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 14, 2021
Estimated Primary Completion Date January 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children with ASD or high risk for autism;
  • Han ethic;
  • Parents were at least middle school educated, and agreed to do at least 20 hours per week of planned practice activities with the child in daily life.

Exclusion Criteria:

  • Children with Syndromic ASD caused by known genetic defects or inherited metabolic diseases , such as Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis;
  • Visual, auditory and physical disabilities;
  • Complication with other serious chronic diseases, such as liver and kidney failure, connective tissue diseases, tumors.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 54 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiu Xu, Doctor +86-18017590862 xuxiu@shmu.edu.cn
Contact: Ying Zhang, Master +86-15221837786 yzhang002@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03864289
Other Study ID Numbers  ICMJE FDEK-PST-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital of Fudan University
Study Sponsor  ICMJE Children's Hospital of Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiu Xu, Doctor Children's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP