Social Cognitive Development in Young Children With Autism

March 9, 2021 updated by: Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Effects of Self-Generated Experiences on Social Cognitive Development in Young Children With Autism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21211
        • Kennedy Krieger Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Social Enhancement Intervention
  • 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.
Behavioral: Social Enhancement Intervention
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.
Behavioral: Parent Education
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.
Active Comparator: Parent Education
o Parent education sessions once a week for 2 hours each session over the 5-month period.
Behavioral: Parent Education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Baseline Eye Tracking Tasks
Time Frame: 5 months into treatment and 5 months after the treatment ends
5 months into treatment and 5 months after the treatment ends
Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile
Time Frame: 5 months into treatment and 5 months after the treatment ends
5 months into treatment and 5 months after the treatment ends
Change in Baseline Spontaneous Imitation Task
Time Frame: 5 months into treatment and 5 months after the treatment ends
5 months into treatment and 5 months after the treatment ends

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Baseline Autism Diagnostic Observation Schedule
Time Frame: 5 months into treatment and 5 months after the treatment ends
5 months into treatment and 5 months after the treatment ends
Change in Baseline Mullen Scales of Early Learning
Time Frame: 5 months into treatment and 5 months after the treatment ends
5 months into treatment and 5 months after the treatment ends
Change in Baseline Action/intention understanding taks
Time Frame: 5 months into treatment and 5 months after the treatment ends
5 months into treatment and 5 months after the treatment ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborators

Autism Speaks

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

August 29, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00050400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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