Skip to content

Social Cognitive Development in Young Children With Autism

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01425918
Enrollment
61
Registered
2011-08-30
Start date
2012-01-31
Completion date
2015-04-30
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, language, social, toddlers

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.

Interventions

BEHAVIORALSocial 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 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.

Sponsors

Autism Speaks
CollaboratorOTHER
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
24 Months to 42 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in Baseline Eye Tracking Tasks5 months into treatment and 5 months after the treatment ends
Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile5 months into treatment and 5 months after the treatment ends
Change in Baseline Spontaneous Imitation Task5 months into treatment and 5 months after the treatment ends

Secondary

MeasureTime frame
Change in Baseline Autism Diagnostic Observation Schedule5 months into treatment and 5 months after the treatment ends
Change in Baseline Mullen Scales of Early Learning5 months into treatment and 5 months after the treatment ends
Change in Baseline Action/intention understanding taks5 months into treatment and 5 months after the treatment ends

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026