Early Intervention Program for Children With Autism (BCRI Model)

Autism Spectrum Disorder Clinical Trial

Official title:

Early Intervention Program for Children With Autism (BCRI Model)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00819364
• Other study ID #: 2007024
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 8, 2009
• Last updated: August 10, 2009
• Start date: August 2009
• Est. completion date: August 2016

Study information

• Verified date: August 2009
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• BCRI intervention program
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.
• Standard community care
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychoeducational Profile-3rd Edition(PEP-3)		Measured before and after treatment and at 2-year follow-up	No
Secondary	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.		Measured at 2-year and 5-year follow-up	No