Parent Skills Training for Families of… | Clinical Trial

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 month–54 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: PST

Primary outcomes

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%.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2022
First posted: Mar 6, 2019
Registry last updated: Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed