Parent Skills Training for Families of Children With Autism Spectrum Disorder

NCT03864289 | Completed

• 1 other identifier: FDEK-PST-2019
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Parent skills training

EXPERIMENTAL

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

Interventions

Parent skills training BEHAVIORAL

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

Also known as: PST

Parent skills training

Eligibility Criteria

• Age: 18 Months - 54 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xiu Xu, Doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 6, 2019
• Study Start: March 15, 2019
• Primary Completion: December 14, 2021
• Study Completion: March 14, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-02

Locations

CN (1)