Parent Skills Training for Families of Children With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Parent Skills Training for Families of Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864289
• Other study ID #: FDEK-PST-2019
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: March 14, 2022

Study information

• Verified date: February 2021
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 14, 2022
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 54 Months

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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

Locations

Country	Name	City	State
China	Children's hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From enrollment to end of training(8 week). The score will be measured at the following time point: enrollment,end of training.
Primary	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%.	From enrollment to end of training(8 week). The correct rate will be measured at the following time point: enrollment, end of training.