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Social Cognitive Development in Young Children With Autism

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Enhancement Intervention
Parent Education
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 Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, language, social, toddlers

Eligibility Criteria

24 Months - 42 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must be 24 to 42 months old
  • Children must meet criteria for ASD or autism on the ADOS (Lord et al., 2000) plus receive a clinical judgment of PDD-NOS or autism by the study team
  • Score ≥ 16 months on the Visual Receptive subtest and ≥ 9 months on the Receptive Language subtest on the Mullen Scales of Early Learning and/or the Vineland Adaptive Behavior Scales at the time of eligibility testing.
  • The parent (or other primary caregiver, such as grandparent) in the PE condition must agree to attend the training sessions each week for the 5-month period.
  • The parent must agree to bring their child in for testing at all testing points (pre-testing, post-testing, follow-up testing).
  • Parents must be between the ages of 18 and 65 years old
  • It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home)

Exclusion Criteria:

  • <34 weeks or >42 weeks gestational age
  • <2500 grams birth weight, severe birth trauma
  • Head or serious bodily injury sustained before or during the study
  • Illicit drug or excessive alcohol exposure (defined in our telephone screening interview)
  • Major hearing or visual impairment
  • Non-febrile seizures
  • Any known genetic syndrome
  • Mitochondrial disorders
  • Severe birth defects
  • No foster children may participate
  • The child must not be adopted
  • The child must not be participating in another intervention study simultaneously or be simultaneously enrolled in the CARD clinic's Achievements, Early Achievements, TIPS, Jump Start, or Play with Me programs.
  • Unable to provide baseline data on the eye tracking measure at time of pretesting (e.g., tracker unable to read eye movements)
  • Has a sibling participating in this study

Sites / Locations

  • Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Social Enhancement Intervention

Parent Education

Arm Description

For 5 months children will come in 4 days a week for 2-2.5 hours a session to participate in a classroom in an attempt to increase social communication and understanding. Parent education sessions once a week for 2 hours each session over the 5-month period.

o Parent education sessions once a week for 2 hours each session over the 5-month period.

Outcomes

Primary Outcome Measures

Change in Baseline Eye Tracking Tasks
Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile
Change in Baseline Spontaneous Imitation Task

Secondary Outcome Measures

Change in Baseline Autism Diagnostic Observation Schedule
Change in Baseline Mullen Scales of Early Learning
Change in Baseline Action/intention understanding taks

Full Information

First Posted
June 13, 2011
Last Updated
March 9, 2021
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Autism Speaks
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1. Study Identification

Unique Protocol Identification Number
NCT01425918
Brief Title
Social Cognitive Development in Young Children With Autism
Official Title
Effects of Self-Generated Experiences on Social Cognitive Development in Young Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (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
Autism Speaks

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, language, social, toddlers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Enhancement Intervention
Arm Type
Experimental
Arm Description
For 5 months children will come in 4 days a week for 2-2.5 hours a session to participate in a classroom in an attempt to increase social communication and understanding. Parent education sessions once a week for 2 hours each session over the 5-month period.
Arm Title
Parent Education
Arm Type
Active Comparator
Arm Description
o Parent education sessions once a week for 2 hours each session over the 5-month period.
Intervention Type
Behavioral
Intervention Name(s)
Social Enhancement Intervention
Intervention Description
The intervention will be conducted at our center and focuses on providing an invigorating learning environment in which emerging social skills/knowledge are the focus of intervention with the aim of bringing them to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children robust learning experiences. Parent training sessions will focus on strategies aimed at improving child social engagement and communication.
Intervention Type
Behavioral
Intervention Name(s)
Parent Education
Intervention Description
Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources. The curriculum provides parents with information about child development and autism as well as instructional strategies (e.g., responsive teaching strategies, principles of applied behavior analysis) for use at home to enhance their children's communication, engagement, and play development. Concrete examples for home-based implementation are presented. Each week, homework will be given and parents will be encouraged to practice the strategies daily at home. No direct coaching to parents during interaction with their children or direct intervention with the child will be provided.
Primary Outcome Measure Information:
Title
Change in Baseline Eye Tracking Tasks
Time Frame
5 months into treatment and 5 months after the treatment ends
Title
Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile
Time Frame
5 months into treatment and 5 months after the treatment ends
Title
Change in Baseline Spontaneous Imitation Task
Time Frame
5 months into treatment and 5 months after the treatment ends
Secondary Outcome Measure Information:
Title
Change in Baseline Autism Diagnostic Observation Schedule
Time Frame
5 months into treatment and 5 months after the treatment ends
Title
Change in Baseline Mullen Scales of Early Learning
Time Frame
5 months into treatment and 5 months after the treatment ends
Title
Change in Baseline Action/intention understanding taks
Time Frame
5 months into treatment and 5 months after the treatment ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must be 24 to 42 months old Children must meet criteria for ASD or autism on the ADOS (Lord et al., 2000) plus receive a clinical judgment of PDD-NOS or autism by the study team Score ≥ 16 months on the Visual Receptive subtest and ≥ 9 months on the Receptive Language subtest on the Mullen Scales of Early Learning and/or the Vineland Adaptive Behavior Scales at the time of eligibility testing. The parent (or other primary caregiver, such as grandparent) in the PE condition must agree to attend the training sessions each week for the 5-month period. The parent must agree to bring their child in for testing at all testing points (pre-testing, post-testing, follow-up testing). Parents must be between the ages of 18 and 65 years old It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home) Exclusion Criteria: <34 weeks or >42 weeks gestational age <2500 grams birth weight, severe birth trauma Head or serious bodily injury sustained before or during the study Illicit drug or excessive alcohol exposure (defined in our telephone screening interview) Major hearing or visual impairment Non-febrile seizures Any known genetic syndrome Mitochondrial disorders Severe birth defects No foster children may participate The child must not be adopted The child must not be participating in another intervention study simultaneously or be simultaneously enrolled in the CARD clinic's Achievements, Early Achievements, TIPS, Jump Start, or Play with Me programs. Unable to provide baseline data on the eye tracking measure at time of pretesting (e.g., tracker unable to read eye movements) Has a sibling participating in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Landa, PhD, CCC-SLP
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
background
PubMed Identifier
20828580
Citation
Libertus K, Needham A. Teach to reach: the effects of active vs. passive reaching experiences on action and perception. Vision Res. 2010 Dec;50(24):2750-7. doi: 10.1016/j.visres.2010.09.001. Epub 2010 Sep 7.
Results Reference
background
PubMed Identifier
17216332
Citation
Sullivan M, Finelli J, Marvin A, Garrett-Mayer E, Bauman M, Landa R. Response to joint attention in toddlers at risk for autism spectrum disorder: a prospective study. J Autism Dev Disord. 2007 Jan;37(1):37-48. doi: 10.1007/s10803-006-0335-3. Epub 2007 Jan 10.
Results Reference
background

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Social Cognitive Development in Young Children With Autism

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