Clinical trial NCT01425918: Social Cognitive Development in Young Children With Autism
Official title: Effects of Self-Generated Experiences on Social Cognitive Development in Young Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
language
social
toddlers
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2011-08-30
Enrollment: 61
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Baseline Eye Tracking Tasks
timeFrame: 5 months into treatment and 5 months after the treatment ends
measure: Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile
timeFrame: 5 months into treatment and 5 months after the treatment ends
measure: Change in Baseline Spontaneous Imitation Task
timeFrame: 5 months into treatment and 5 months after the treatment ends
Secondary outcomes:
measure: Change in Baseline Autism Diagnostic Observation Schedule
timeFrame: 5 months into treatment and 5 months after the treatment ends
measure: Change in Baseline Mullen Scales of Early Learning
timeFrame: 5 months into treatment and 5 months after the treatment ends
measure: Change in Baseline Action/intention understanding taks
timeFrame: 5 months into treatment and 5 months after the treatment ends
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Rebecca Landa, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.