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Autism Spectrum DisorderNCT01425918

Social Cognitive Development in Young Children With Autism

A study testing Social Enhancement Intervention and Parent Education in people with Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 24 to 42 monthsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Social Enhancement Intervention and Parent Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited States
Study dates
Jan 2012to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 42 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

  • <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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21211

Other trials in United States

About this study

Official title: Effects of Self-Generated Experiences on 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.

Being tested
Social Enhancement Intervention, Parent Education
Keywords
Autism Spectrum Disorder, language, social, toddlers
Medical subject headings
Autism Spectrum Disorder, Language

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social Enhancement InterventionBehavioural

    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 EducationBehavioural

    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.

Study groups in NCT01425918
Study groupRoleWhat they receive
Social Enhancement InterventionExperimental* 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.
Receives: Behavioral: Social Enhancement Intervention; Behavioral: Parent Education
Parent EducationActive comparatoro Parent education sessions once a week for 2 hours each session over the 5-month period.
Receives: Behavioral: Parent Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Baseline Eye Tracking Tasks

    Measured: 5 months into treatment and 5 months after the treatment ends

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

    Measured: 5 months into treatment and 5 months after the treatment ends

  3. Change in Baseline Spontaneous Imitation Task

    Measured: 5 months into treatment and 5 months after the treatment ends

Secondary outcomes (3)

  1. Change in Baseline Autism Diagnostic Observation Schedule

    Measured: 5 months into treatment and 5 months after the treatment ends

  2. Change in Baseline Mullen Scales of Early Learning

    Measured: 5 months into treatment and 5 months after the treatment ends

  3. Change in Baseline Action/intention understanding taks

    Measured: 5 months into treatment and 5 months after the treatment ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01425918
Sponsor's protocol ID
NA_00050400
Status last verified
Mar 2021
First submitted
13 Jun 2011
Last updated
10 Mar 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21126245

  • 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.

    PubMed 20828580

  • 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.

    PubMed 17216332

Questions about this trial

What is this clinical trial studying?

A study testing Social Enhancement Intervention and Parent Education in people with Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Baseline Eye Tracking Tasks (time frame: 5 months into treatment and 5 months after the treatment ends). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01425918, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.

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