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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
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, early intervention, BCRI model

Eligibility Criteria

undefined - 30 Months (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 8, 2009
    Last Updated
    August 10, 2009
    Sponsor
    Sun Yat-sen University
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    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)

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