Social Cognitive Development in Young Children With Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Social Enhancement Intervention; Behavioral: Parent Education

• Registration Number: NCT01425918
• Lead Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Study Start: 2012-01
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Enhancement Intervention	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.
Social Enhancement Intervention	Parent Education	* 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.
Parent Education	Parent Education	o Parent education sessions once a week for 2 hours each session over the 5-month period.

Primary Outcome Measures

Name	Time	Method
Change in Baseline Eye Tracking Tasks	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
Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile	5 months into treatment and 5 months after the treatment ends

Secondary Outcome Measures

Name	Time	Method
Change in Baseline Action/intention understanding taks	5 months into treatment and 5 months after the treatment ends
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

Trial Locations

Locations (1)

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States