School- and Home-Based Early Intervention for Toddlers With Autism
Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
2 other identifiers
interventional
50
1 country
1
Brief Summary
This study will determine the impact of early intervention on the communication and social development of toddlers with autism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 21, 2005
CompletedFirst Posted
Study publicly available on registry
March 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJuly 8, 2013
July 1, 2013
4.3 years
March 21, 2005
July 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Receptive language skills
Pre-tx, Post-tx, and 6 month follow up
Expressive language skills
Pre-tx, Post-tx, and 6 month follow up
Secondary Outcomes (3)
Social cognitive skills
Pre-tx, Post-tx, and 6 month follow up
Social emotional functioning
Pre-tx, Post-tx, and 6 month follow up
Play skills
Pre-tx, Post-tx, and 6 month follow up
Study Arms (2)
1
EXPERIMENTALBehavioral Intervention (experimental)
2
ACTIVE COMPARATORBehavioral Intervention 2
Interventions
Early intervention blending several different treatment approaches, with a focus on certain skills
Early intervention blending several different treatment approaches
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kennedy Krieger Institute
Baltimore, Maryland, 21211, United States
Related Publications (1)
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.
PMID: 21126245DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Landa, PhD
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins University School of Medicine
Study Record Dates
First Submitted
March 21, 2005
First Posted
March 22, 2005
Study Start
May 1, 2003
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
July 8, 2013
Record last verified: 2013-07