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

H

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Status

Completed

Conditions

Autistic Disorder
Autism

Treatments

Behavioral: Early intervention blending several tx approaches, w/ focus
Behavioral: Early intervention blending several treatment approaches

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00106210
U54MH066417 (U.S. NIH Grant/Contract)
DDTR BD-DD

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 33 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups

1
Experimental group
Description:
Behavioral Intervention (experimental)
Treatment:
Behavioral: Early intervention blending several tx approaches, w/ focus
2
Active Comparator group
Description:
Behavioral Intervention 2
Treatment:
Behavioral: Early intervention blending several treatment approaches

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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