Clinical trial NCT00819364: Early Intervention Program for Children With Autism (BCRI Model)
Official title: Early Intervention Program for Children With Autism (BCRI Model)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: Autism
early intervention
BCRI model
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-01-09
Enrollment: 200
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Psychoeducational Profile-3rd Edition(PEP-3)
timeFrame: Measured before and after treatment and at 2-year follow-up
Secondary outcomes:
measure: 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.
timeFrame: Measured at 2-year and 5-year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Zou Xiaobing, M.D.
role: PRINCIPAL_INVESTIGATOR
References: