The purpose of this study is to determine the impact of early intervention on communication and social development of toddlers with autism.

Study hypothesis: Early intervention will result in increased social and emotional functioning in toddlers with autism.

Condition	Treatment or Intervention
Autistic Disorder Autism	Behavior: Early intervention blending several different treatment approaches

Further Study Details: 

Primary Outcomes: Receptive language skills; Expressive language skills
Secondary Outcomes: Social cognitive skills; Social emotional functioning; Play skills
Expected Total Enrollment:  50

Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism.

This study will last 6 months. Autistic children enrolled in a school for autistic children in one of two parallel classes will receive one of two treatments 4 days a week for the duration of the study. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.

Ages Eligible for Study:  18 Months   -   33 Months,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of autism spectrum disorder
• Parent or guardian willing to give informed consent for child's participation
• Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales
• English is primary language for child and family

Exclusion Criteria:

• Evidence of vision or hearing impairment
• Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella
• History of severe birth trauma or traumatic brain injury
• Siblings with autism spectrum disorder

Rebecca Landa, PhD      443-923-7892    Landa@kennedykrieger.org
Katherine Holman, PhD      410-923-7623    HolmanK@kennedykrieger.org

Maryland
      Kennedy Krieger Institute, Baltimore,  Maryland,  21211,  United States; Recruiting

Study chairs or principal investigators

Rebecca Landa, PhD,  Principal Investigator,  Kennedy Krieger Institute   

Study ID Numbers:  MH66417-01A1; NIMH 1 U54 MH0 66417-01A1
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  March 21, 2005
ClinicalTrials.gov Identifier:  NCT00106210
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08