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OpenTrials
Completed

NCT Number: NCT01425918

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Language Mental Disorders Neurodevelopmental Disorders

Age range

24 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Baseline Eye Tracking Tasks

    Time frame: 5 months into treatment and 5 months after the treatment ends

  2. Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile

    Time frame: 5 months into treatment and 5 months after the treatment ends

  3. Change in Baseline Spontaneous Imitation Task

    Time frame: 5 months into treatment and 5 months after the treatment ends

Secondary outcomes

  1. Change in Baseline Autism Diagnostic Observation Schedule

    Time frame: 5 months into treatment and 5 months after the treatment ends

  2. Change in Baseline Mullen Scales of Early Learning

    Time frame: 5 months into treatment and 5 months after the treatment ends

  3. Change in Baseline Action/intention understanding taks

    Time frame: 5 months into treatment and 5 months after the treatment ends

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Autism Speaks

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 30, 2011
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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