Early Intervention Program for Children With Autism (BCRI Model)

NCT00819364 | Unknown DMC

• 1 other identifier: 2007024
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism; Autism Spectrum Disorder

Keywords

Autism; early intervention; BCRI model

Outcome Measures

Primary Outcomes (1)

• Psychoeducational Profile-3rd Edition(PEP-3)

  Measured before and after treatment and at 2-year follow-up

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Participants with autism will receive BCRI intervention program.

Behavioral: BCRI intervention program

2

ACTIVE COMPARATOR

Participants with autism will receive standard care available in the community.

Behavioral: Standard community care

Interventions

BCRI intervention program BEHAVIORAL

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.

1

Standard community care BEHAVIORAL

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.

2

Eligibility Criteria

• Age: Up to 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Zou Xiaobing, M.D.

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2016
• Last Updated: August 11, 2009

Record last verified: 2009-08