Social Cognitive Development in Young Children With Autism

NCT01425918 | Completed

• 1 other identifier: NA_00050400
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; language; social; toddlers

Outcome Measures

Primary Outcomes (3)

• Change in Baseline Eye Tracking Tasks

  5 months into treatment and 5 months after the treatment ends

• Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile

  5 months into treatment and 5 months after the treatment ends

• Change in Baseline Spontaneous Imitation Task

  5 months into treatment and 5 months after the treatment ends

Secondary Outcomes (3)

• Change in Baseline Autism Diagnostic Observation Schedule

  5 months into treatment and 5 months after the treatment ends

• Change in Baseline Mullen Scales of Early Learning

  5 months into treatment and 5 months after the treatment ends

• Change in Baseline Action/intention understanding taks

  5 months into treatment and 5 months after the treatment ends

Study Arms (2)

Social Enhancement Intervention

EXPERIMENTAL

* 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; Behavioral: Parent Education

Parent Education

ACTIVE COMPARATOR

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

Behavioral: Parent Education

Interventions

Social Enhancement Intervention BEHAVIORAL

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.

Social Enhancement Intervention

Parent Education BEHAVIORAL

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.

Parent Education; Social Enhancement Intervention

Eligibility Criteria

• Age: 24 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• \<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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Autism Speaks: collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

Related Publications (3)

• 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: 21126245 BACKGROUND

• 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.

  PMID: 20828580 BACKGROUND

• 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.

  PMID: 17216332 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Language

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Study Officials

• Rebecca Landa, PhD, CCC-SLP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: August 30, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

US (1)