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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00106210
First Posted: March 22, 2005
Last Update Posted: July 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
March 21, 2005
March 22, 2005
July 8, 2013
May 2003
September 2007   (Final data collection date for primary outcome measure)
  • Receptive language skills [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ]
  • Expressive language skills [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ]
  • Receptive language skills
  • Expressive language skills
Complete list of historical versions of study NCT00106210 on ClinicalTrials.gov Archive Site
  • Social cognitive skills [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ]
  • Social emotional functioning [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ]
  • Play skills [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ]
  • Social cognitive skills
  • Social emotional functioning
  • Play skills
Not Provided
Not Provided
 
School- and Home-Based Early Intervention for Toddlers With Autism
Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
This study will determine the impact of early intervention on the communication and social development of toddlers with autism.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Autistic Disorder
  • Autism
  • Behavioral: Early intervention blending several tx approaches, w/ focus
    Early intervention blending several different treatment approaches, with a focus on certain skills
  • Behavioral: Early intervention blending several treatment approaches
    Early intervention blending several different treatment approaches
  • Experimental: 1
    Behavioral Intervention (experimental)
    Intervention: Behavioral: Early intervention blending several tx approaches, w/ focus
  • Active Comparator: 2
    Behavioral Intervention 2
    Intervention: Behavioral: Early intervention blending several treatment approaches
Landa RJ, Holman KC, O'Neill AH, Stuart EA. Intervention targeting development of socially synchronous engagement in toddlers with autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2011 Jan;52(1):13-21. doi: 10.1111/j.1469-7610.2010.02288.x. Epub 2010 Dec 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2007
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Months to 33 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00106210
U54MH066417( U.S. NIH Grant/Contract )
U54MH066417 ( U.S. NIH Grant/Contract )
DDTR BD-DD
No
Not Provided
Not Provided
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
National Institute of Mental Health (NIMH)
Principal Investigator: Rebecca Landa, PhD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP