Clinical trial NCT03864289: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline average score of the Interaction Fidelity Rating System at 8 weeks
timeFrame: From enrollment to end of training（8 week）. The score will be measured at the following time point: enrollment,end of training.
measure: Change from baseline correct answer rate of the Questionnaire on Awareness and Knowledge of Interventions about Autism at 8 weeks
timeFrame: From enrollment to end of training（8 week）. The correct rate will be measured at the following time point: enrollment, end of training.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiu Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: