School- and Home-Based Early Intervention for Toddlers With Autism

Autism Clinical Trial

Official title:

Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106210
• Other study ID #: U54MH066417
• Secondary ID: U54MH066417DDTR
• Status: Completed
• Phase: N/A
• First received: March 21, 2005
• Last updated: July 3, 2013
• Start date: May 2003
• Est. completion date: September 2007

Study information

• Verified date: July 2013
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will determine the impact of early intervention on the communication and social development of toddlers with autism.

Description:

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.

Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 33 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Behavioral:
• Early intervention blending several tx approaches, w/ focus
Early intervention blending several different treatment approaches, with a focus on certain skills
• Early intervention blending several treatment approaches
Early intervention blending several different treatment approaches

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receptive language skills		Pre-tx, Post-tx, and 6 month follow up	No
Primary	Expressive language skills		Pre-tx, Post-tx, and 6 month follow up	No
Secondary	Social cognitive skills		Pre-tx, Post-tx, and 6 month follow up	No
Secondary	Social emotional functioning		Pre-tx, Post-tx, and 6 month follow up	No
Secondary	Play skills		Pre-tx, Post-tx, and 6 month follow up	No

External Links

•   Click here for the Autism and Neuro-Psychiatric Disorders Research at the Kennedy Krieger Institute Web site
•   Click here for the Center for Autism and Related Disorders (CARD) at the Kennedy Krieger Institute Web site