Autism Spectrum DisorderNCT03864289
Parent Skills Training for Families of Children With Autism Spectrum Disorder
A study testing Parent skills training in people with Autism Spectrum Disorder, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 54 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Parent skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2019to 14 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Parent skills training
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent skills trainingBehavioural
Also called PST
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parent skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: From enrollment to end of training（8 week）. The correct rate will be measured at the following time point: enrollment, end of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start15 Mar 2019
- Primary completion14 Dec 2021
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, Doctor, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864289
- Sponsor's protocol ID
- FDEK-PST-2019
- Status last verified
- Feb 2021
- First submitted
- 4 Mar 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Skills Training for Families of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03864289
- Acronym / sponsor ID
- FDEK-PST-2019
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent skills training | Experimental | Behavioral: Parent skills trainingParents 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. |
Who may qualify
- Ages
- 18 to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent skills trainingAlso: PSTParents 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 | Behavioural | Parent skills training |
Primary outcome
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiu Xu, Doctor principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent skills training in people with Autism Spectrum Disorder, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.