Social Cognitive Development in Young Children With Autism - Full Text View

Purpose

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.

Condition	Intervention
Autism Spectrum Disorder	Behavioral: Social Enhancement Intervention Behavioral: Parent Training

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Self-Generated Experiences on Social Cognitive Development in Young Children With Autism

Resource links provided by NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:

Change in Baseline Eye Tracking Tasks [ Time Frame: 5 months into treatment and 5 months after the treatment ends ] [ Designated as safety issue: No ]
Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile [ Time Frame: 5 months into treatment and 5 months after the treatment ends ] [ Designated as safety issue: No ]
Change in Baseline Spontaneous Imitation Task [ Time Frame: 5 months into treatment and 5 months after the treatment ends ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Baseline Autism Diagnostic Observation Schedule [ Time Frame: 5 months into treatment and 5 months after the treatment ends ] [ Designated as safety issue: No ]
Change in Baseline Mullen Scales of Early Learning [ Time Frame: 5 months into treatment and 5 months after the treatment ends ] [ Designated as safety issue: No ]
Change in Baseline Action/intention understanding taks [ Time Frame: 5 months into treatment and 5 months after the treatment ends ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Training 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 Training 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.

Arms

Assigned Interventions

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 Training

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 Training

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.

Eligibility

Ages Eligible for Study:	24 Months to 42 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425918

Contacts

Contact: Rebecca Landa, PhD, CCC-SLP	443-923-7632	landa@kennedykrieger.org
Contact: Catherine Walton	443-923-7608	WaltonC@kennedykrieger.org

Locations

United States, Maryland
Kennedy Krieger Institute	Recruiting
Baltimore, Maryland, United States, 21211
Contact: Rebecca Landa, Phd, CCC-SLP 443-923-7632 landa@kennedykrieger.org
Contact: Catherine Walton 443-923-7608 WaltonC@kennedykrieger.org
Principal Investigator: Rebecca Landa, PhD, CCC-SLP

Sponsors and Collaborators

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

Autism Speaks

Investigators

Principal Investigator:

Rebecca Landa, PhD, CCC-SLP

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

More Information

Publications:

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. Epub 2010 Dec 3.

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. Epub 2010 Sep 7.

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. Epub 2007 Jan 10.

Responsible Party:	Rebecca Landa, Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:	NCT01425918 History of Changes
Other Study ID Numbers:	NA_00050400
Study First Received:	June 13, 2011
Last Updated:	January 4, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Autism Spectrum Disorder
language
social
toddlers

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013