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Parent Skills Training for Families of Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Parent skills training
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Months - 54 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's hospital of Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parent skills training

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline average score of the Interaction Fidelity Rating System at 8 weeks
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
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%.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2019
Last Updated
March 30, 2022
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03864289
Brief Title
Parent Skills Training for Families of Children With Autism Spectrum Disorder
Official Title
Parent Skills Training for Families of Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
March 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent skills training
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Parent skills training
Other Intervention Name(s)
PST
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline average score of the Interaction Fidelity Rating System at 8 weeks
Description
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.
Time Frame
From enrollment to end of training(8 week). The score will be measured at the following time point: enrollment,end of training.
Title
Change from baseline correct answer rate of the Questionnaire on Awareness and Knowledge of Interventions about Autism at 8 weeks
Description
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%.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiu Xu, Doctor
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

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Parent Skills Training for Families of Children With Autism Spectrum Disorder

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