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Completed

NCT Number: NCT00106210

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

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

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Key information

Age range

18 month–33 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early intervention blending several tx approaches, w/ focus

Behavioral

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

Early intervention blending several treatment approaches

Behavioral

Early intervention blending several different treatment approaches

Primary outcomes

  1. Receptive language skills

    Time frame: Pre-tx, Post-tx, and 6 month follow up

  2. Expressive language skills

    Time frame: Pre-tx, Post-tx, and 6 month follow up

Secondary outcomes

  1. Social cognitive skills

    Time frame: Pre-tx, Post-tx, and 6 month follow up

  2. Social emotional functioning

    Time frame: Pre-tx, Post-tx, and 6 month follow up

  3. Play skills

    Time frame: Pre-tx, Post-tx, and 6 month follow up

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Mar 22, 2005
Registry last updated
Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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