Parent Skills Training for Families of Children With Autism Spectrum Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03864289|
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Behavioral: Parent skills training||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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%.
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
|Contact: Xiu Xu, Doctorfirstname.lastname@example.org|
|Contact: Ying Zhang, Masteremail@example.com|
|Children's hospital of Fudan University||Not yet recruiting|
|Shanghai, Shanghai, China, 201102|
|Contact: Xiu Xu, Doctor +86-18017590862 firstname.lastname@example.org|
|Contact: Ying Zhang, Master +86-15221837786 email@example.com|
|Principal Investigator:||Xiu Xu, Doctor||Children's Hospital of Fudan University|