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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

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Parent skills training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parent Skills Training for Families of Children With Autism Spectrum Disorder
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : January 14, 2021
Estimated Study Completion Date : March 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


  2. 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%.



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Ages Eligible for Study:   18 Months to 54 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864289


Contacts
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Contact: Xiu Xu, Doctor +86-18017590862 xuxiu@shmu.edu.cn
Contact: Ying Zhang, Master +86-15221837786 yzhang002@126.com

Locations
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China, Shanghai
Children's hospital of Fudan University Not yet recruiting
Shanghai, Shanghai, China, 201102
Contact: Xiu Xu, Doctor    +86-18017590862    xuxiu@shmu.edu.cn   
Contact: Ying Zhang, Master    +86-15221837786    yzhang002@126.com   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Principal Investigator: Xiu Xu, Doctor Children's Hospital of Fudan University

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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03864289     History of Changes
Other Study ID Numbers: FDEK-PST-2019
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders