Early Intervention Program for Children With Autism (BCRI Model)
| Tracking Information | |||||
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| First Received Date ICMJE | January 8, 2009 | ||||
| Last Updated Date | August 10, 2009 | ||||
| Start Date ICMJE | August 2009 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Psychoeducational Profile-3rd Edition(PEP-3) [ Time Frame: Measured before and after treatment and at 2-year follow-up ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Psychoeducational Profile-Revised(PEP-R) [ Time Frame: Measured before and after treatment and at 2-year follow-up ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00819364 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Psychoeducational Profile-Revised(PEP-R),WISC-III scores, whether enrolled to a mainstream school [ Time Frame: Measured at 5-year follow-up ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Intervention Program for Children With Autism (BCRI Model) | ||||
| Official Title ICMJE | Early Intervention Program for Children With Autism (BCRI Model) | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | August 2016 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Autistic Participants:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 30 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00819364 | ||||
| Other Study ID Numbers ICMJE | 2007024 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | The Third Affliated Hospital of Sun Yat-sen University | ||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sun Yat-sen University | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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