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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2007-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Autistic Disorder Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Behavioral Intervention (experimental)

Group Type EXPERIMENTAL

Early intervention blending several tx approaches, w/ focus

Intervention Type BEHAVIORAL

Early intervention blending several different treatment approaches, with a focus on certain skills

2

Behavioral Intervention 2

Group Type ACTIVE_COMPARATOR

Early intervention blending several treatment approaches

Intervention Type BEHAVIORAL

Early intervention blending several different treatment approaches

Interventions

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Early intervention blending several tx approaches, w/ focus

Early intervention blending several different treatment approaches, with a focus on certain skills

Intervention Type BEHAVIORAL

Early intervention blending several treatment approaches

Early intervention blending several different treatment approaches

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Maximum Eligible Age

33 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No