Social Cognitive Development in Young Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425918
• Other study ID #: NA_00050400
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: April 2015

Study information

• Verified date: March 2021
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 42 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Autism Speaks

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. Epub 2007 Jan 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline Eye Tracking Tasks		5 months into treatment and 5 months after the treatment ends
Primary	Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile		5 months into treatment and 5 months after the treatment ends
Primary	Change in Baseline Spontaneous Imitation Task		5 months into treatment and 5 months after the treatment ends
Secondary	Change in Baseline Autism Diagnostic Observation Schedule		5 months into treatment and 5 months after the treatment ends
Secondary	Change in Baseline Mullen Scales of Early Learning		5 months into treatment and 5 months after the treatment ends
Secondary	Change in Baseline Action/intention understanding taks		5 months into treatment and 5 months after the treatment ends