Early Intervention Program for Children With Autism (BCRI Model)
Primary Purpose
Autism, Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BCRI intervention program
Standard community care
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, early intervention, BCRI model
Eligibility Criteria
Inclusion Criteria for Autistic Participants:
- younger than 30-month old
- must be diagnosed as Autism Spectrum Disorder(autism, PDD-NOS, Asperger's disorder)according to the diagnostic criteria in DSM-IV, or showing symptoms that child may be developing autism.
- Within 2 hour drive of the third affiliated hospital of SUMS.
- Willing to participate in either of 2 randomly assigned treatment groups and carry out the intervention as advices. Attendance at all activities and sessions.
- Both of the parents at least get a high school degree.
Exclusion Criteria:
- Rett syndrome.
- mental retardation associated with brain injury, fragile X syndrome, tuberous sclerosis, phenyl ketonuria, phenyl ketonuria, Angelman syndrome、Prader-Willi syndrome and autism accompanied with sensory or motor impairments.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants with autism will receive BCRI intervention program.
Participants with autism will receive standard care available in the community.
Outcomes
Primary Outcome Measures
Psychoeducational Profile-3rd Edition(PEP-3)
Secondary Outcome Measures
SRS(social response scale) scores and/or C-WYCSI scores at 2-year follow-up. SRS(social response scale) scores and/or C-WYSC scores at 5-year follow-up.
Full Information
NCT ID
NCT00819364
First Posted
January 8, 2009
Last Updated
August 10, 2009
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT00819364
Brief Title
Early Intervention Program for Children With Autism (BCRI Model)
Official Title
Early Intervention Program for Children With Autism (BCRI Model)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized controlled study to determine whether the BCRI (Behavior-Cognition-Relationship Intervention) model is effective for the autistic children. BCRI model is a eclectic method using behavior modification, structure teaching, relationship-focus approaches according to the symptom severity and main problems at any stage of training for the autistic children. The BCRI Model emphasis the importance that parents understand the principle of training and education and can use them skillfully, appropriately and persistently.
Detailed Description
In recent years, autism has been found that the outcomes can be much better after early training interventions. The training programs are often categorized as behavior analytic, cognitive or structured teaching, developmental or relationship-focused and so on. Although the approaches focus on different aspect of rehabilitation, they also overlap, playing complementation roles for one another. From our clinical experiences, we find that different children, in their different stages, with different problems, will need different approaches. For example, at early stage behavior modulation method is useful to regulate the child's behaviors. When the child is able to cooperate with adults, structure teaching helps him/her improve cognitive ability. Relationship-focused methods may help the child on social interaction. BCRI model, a comprehensive model, is based on the three kinds of approaches above.
All the autistic children will receive examinations before assignment, including history and symptoms collection, diagnostic interview, evaluation(using PEP-3 for autistic children to evaluate intelligence level). DQ is calculated through PEP-3 assessment. (DQ, development quotient, equals to development age in month over chronological age in month). Children will be randomly assigned to one of two interventions arms: BCRI intervention program or standard community care.
BCRI intervention program aims to teach the parents to master how to apply correct approaches and strategies and hold the training both at home and/or in training institutes. During the program, doctors deliver the knowledge and skills to the parents, set a complete schedule for the intervention, assess the progress and development for the children and communicate with the parents about any problems and frustration. Parents play an important and direct role in the training and educating procedure. The contrast group receives standard community intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder
Keywords
Autism, early intervention, BCRI model
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants with autism will receive BCRI intervention program.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants with autism will receive standard care available in the community.
Intervention Type
Behavioral
Intervention Name(s)
BCRI intervention program
Intervention Description
Phase 1: The parents will receive a two-day lecture about autism to get the basic knowledge about autism intervention.
Phase 2: BCRI model intervention.Parents and children will take part in a 24-halfday workshop to learn practical teaching skills in BCRI model. Then Home-based intervention using BCRI model for 11 months. At least 28 hours of BCRI intervention per week is acquired. Doctors or therapists will meet the parents and children once per month, each for 30 minutes, totally 10 times, to monitor and give advice on the interventions.
Intervention Type
Behavioral
Intervention Name(s)
Standard community care
Intervention Description
Phase 1: the parents will receive a two-day lecture about autism to get the basic knowledge about autism intervention.
Phase 2:Any treatment and interventions available chosen by families for children with autism and ASD, for at least one and a half years.
Phase 3:One and a half years after enrollment, parents and children will be free to take part in the BCRI model intervention which is the same as Phase 2 for experimental group lasting for one year.
Primary Outcome Measure Information:
Title
Psychoeducational Profile-3rd Edition(PEP-3)
Time Frame
Measured before and after treatment and at 2-year follow-up
Secondary Outcome Measure Information:
Title
SRS(social response scale) scores and/or C-WYCSI scores at 2-year follow-up. SRS(social response scale) scores and/or C-WYSC scores at 5-year follow-up.
Time Frame
Measured at 2-year and 5-year follow-up
10. Eligibility
Sex
All
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Autistic Participants:
younger than 30-month old
must be diagnosed as Autism Spectrum Disorder(autism, PDD-NOS, Asperger's disorder)according to the diagnostic criteria in DSM-IV, or showing symptoms that child may be developing autism.
Within 2 hour drive of the third affiliated hospital of SUMS.
Willing to participate in either of 2 randomly assigned treatment groups and carry out the intervention as advices. Attendance at all activities and sessions.
Both of the parents at least get a high school degree.
Exclusion Criteria:
Rett syndrome.
mental retardation associated with brain injury, fragile X syndrome, tuberous sclerosis, phenyl ketonuria, phenyl ketonuria, Angelman syndrome、Prader-Willi syndrome and autism accompanied with sensory or motor impairments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zou Xiaobing, M.D.
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Early Intervention Program for Children With Autism (BCRI Model)
We'll reach out to this number within 24 hrs