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

Not Applicable

Completed

• Conditions: Autistic Disorder; Autism
• Interventions: Behavioral: Early intervention blending several tx approaches, w/ focus; Behavioral: Early intervention blending several treatment approaches

• Registration Number: NCT00106210
• Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-03-21
• Study First Submitted QC: 2005-03-21
• Study First Posted: 2005-03-22
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-03
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Early intervention blending several tx approaches, w/ focus	Behavioral Intervention (experimental)
2	Early intervention blending several treatment approaches	Behavioral Intervention 2

Primary Outcome Measures

Name	Time	Method
Receptive language skills	Pre-tx, Post-tx, and 6 month follow up
Expressive language skills	Pre-tx, Post-tx, and 6 month follow up

Secondary Outcome Measures

Name	Time	Method
Social cognitive skills	Pre-tx, Post-tx, and 6 month follow up
Social emotional functioning	Pre-tx, Post-tx, and 6 month follow up
Play skills	Pre-tx, Post-tx, and 6 month follow up

Trial Locations

Locations (1)

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States