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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00106210
First received: March 21, 2005
Last updated: May 20, 2011
Last verified: February 2008
History of Changes
  Purpose

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


Condition Intervention
Autistic Disorder
Autism
 Behavioral: Early intervention blending several tx approaches, w/ focus
Behavioral: Early intervention blending several treatment approaches

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Receptive language skills [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ] [ Designated as safety issue: No ]
  • Expressive language skills [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social cognitive skills [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ] [ Designated as safety issue: No ]
  • Social emotional functioning [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ] [ Designated as safety issue: No ]
  • Play skills [ Time Frame: Pre-tx, Post-tx, and 6 month follow up ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Behavioral Intervention (experimental)
 Behavioral: Early intervention blending several tx approaches, w/ focus
Early intervention blending several different treatment approaches, with a focus on certain skills
Active Comparator: 2
Behavioral Intervention 2
 Behavioral: Early intervention blending several treatment approaches
Early intervention blending several different treatment approaches

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.

  Eligibility

Ages Eligible for Study:   18 Months to 33 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106210

Locations
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Rebecca Landa, PhD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

Additional Information:
Click here for the Autism and Neuro-Psychiatric Disorders Research at the Kennedy Krieger Institute Web site  This link exits the ClinicalTrials.gov site
Click here for the Autism and Pervasive Developmental Disorders [PDD] Web site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Rebecca Landa, Kennedy Krieger Institute
ClinicalTrials.gov Identifier: NCT00106210     History of Changes
Other Study ID Numbers: U54 MH66417, DDTR BD-DD
Study First Received: March 21, 2005
Last Updated: May 20, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Child

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013