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

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ClinicalTrials.gov Identifier: NCT00106210
Recruitment Status : Completed
First Posted : March 22, 2005
Last Update Posted : July 8, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Tracking Information
First Submitted Date  ICMJE March 21, 2005
First Posted Date  ICMJE March 22, 2005
Last Update Posted Date July 8, 2013
Study Start Date  ICMJE May 2003
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Receptive language skills
  • Expressive language skills
Change History Complete list of historical versions of study NCT00106210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Social cognitive skills
  • Social emotional functioning
  • Play skills
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE School- and Home-Based Early Intervention for Toddlers With Autism
Official Title  ICMJE Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Autistic Disorder
  • Autism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 33 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00106210
Other Study ID Numbers  ICMJE U54MH066417( U.S. NIH Grant/Contract )
U54MH066417 ( U.S. NIH Grant/Contract )
DDTR BD-DD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study Sponsor  ICMJE Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Rebecca Landa, PhD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
PRS Account Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Verification Date July 2013

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