Social Cognitive Development in Young Children With Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01425918
First received: June 13, 2011
Last updated: July 8, 2014
Last verified: July 2014
  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 Education

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:


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 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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: July 8, 2014
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 July 20, 2014