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

Primary Purpose

Autistic Disorder, Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early intervention blending several tx approaches, w/ focus
Early intervention blending several treatment approaches
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Child

Eligibility Criteria

18 Months - 33 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Behavioral Intervention (experimental)

Behavioral Intervention 2

Outcomes

Primary Outcome Measures

Receptive language skills
Expressive language skills

Secondary Outcome Measures

Social cognitive skills
Social emotional functioning
Play skills

Full Information

First Posted
March 21, 2005
Last Updated
July 3, 2013
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00106210
Brief Title
School- and Home-Based Early Intervention for Toddlers With Autism
Official Title
Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Autism
Keywords
Child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Behavioral Intervention (experimental)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Behavioral Intervention 2
Intervention Type
Behavioral
Intervention Name(s)
Early intervention blending several tx approaches, w/ focus
Intervention Description
Early intervention blending several different treatment approaches, with a focus on certain skills
Intervention Type
Behavioral
Intervention Name(s)
Early intervention blending several treatment approaches
Intervention Description
Early intervention blending several different treatment approaches
Primary Outcome Measure Information:
Title
Receptive language skills
Time Frame
Pre-tx, Post-tx, and 6 month follow up
Title
Expressive language skills
Time Frame
Pre-tx, Post-tx, and 6 month follow up
Secondary Outcome Measure Information:
Title
Social cognitive skills
Time Frame
Pre-tx, Post-tx, and 6 month follow up
Title
Social emotional functioning
Time Frame
Pre-tx, Post-tx, and 6 month follow up
Title
Play skills
Time Frame
Pre-tx, Post-tx, and 6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
33 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21126245
Citation
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.
Results Reference
derived
Links:
URL
http://www.kennedykrieger.org/kki_cp.jsp?pid=1394
Description
Click here for the Center for Autism and Related Disorders (CARD) at the Kennedy Krieger Institute Web site
URL
http://www.kennedykrieger.org/kki_research.jsp?pid=1800
Description
Click here for the Autism and Neuro-Psychiatric Disorders Research at the Kennedy Krieger Institute Web site

Learn more about this trial

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

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