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Autism Spectrum DisorderNCT01008800

A Randomized Clinical Trial for Toddlers With ASD

A study testing Social Communication 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

This research is being done to test the effectiveness of two treatments aimed at increasing language and social skills in children with autism spectrum disorder. If children show improvement in these treatments, we hope that the availability of public services for minority and low income families will be increased. Read more about this study

Who is it for?
Ages 22 to 33 months
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Social Communication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteUnited States
Study dates
Sep 2009to Feb 2013
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 22 to 33 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants must be 22 to 33 months old
  • Children must meet criteria for ASD or autism on the ADOS plus receive a clinical judgment of PDD-NOS or autism by the study team
  • Children must have an age equivalent of 8 months or greater for non-verbal ability based on the Mullen Visual Reception and Fine Motor scales
  • Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
  • The parent (or other primary caregiver, such as grandparent) in the Parent-Mediated condition must agree to attend the training sessions three times per month
  • Parents must be between the ages of 16 and 50 years old
  • Families who qualify for medical assistance and/or have racial/ethnic minority backgrounds will be prioritized for recruitment and participation in this study. On the TSI, we will ask participants if they qualify for medical assistance or if they are of a racial minority or have a first degree relative of a racial minority. Families who do not fit these criteria will be notified that they may be eligible to participate if additional space is available.
  • 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

  • Head injury prior to enrollment in the study
  • Major hearing or visual impairment after correction
  • Non-febrile seizures
  • PKU (Phenylketonuria)
  • Congenital Rubella (German measles)
  • Neurofibromatosis
Show all 13Show fewer
  • Tuberous Sclerosis
  • Fragile X
  • A fall resulting in a loss of consciousness or other severe head injury
  • Velo-Cardio Facial Syndrome
  • Any other known genetic syndrome
  • No foster children may participate
  • The child must not be adopted

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: Parent-mediated vs Center-based Intervention for Toddlers With ASD: An RCT

This research is being done to test the effectiveness of two treatments aimed at increasing language and social skills in children with autism spectrum disorder. If children show improvement in these treatments, we hope that the availability of public services for minority and low income families will be increased. Minority and low income families with children between 22 and 33 months of age with Autism Spectrum Disorders may join.

Being tested
Social Communication
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 CommunicationBehavioural

    The Center-Based classroom intervention focuses on providing children with an invigorating, motivating learning environment in which emerging skills and knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement week may offer the children experiences that they would not otherwise have (Ramey \& Ramey, 1998). Parent training sessions will focus on strategies aimed at improving child social engagement and communication and on topics related to autism characteristics, learning styles, interventions, and resources.

  • Social communicationBehavioural

    Parent training sessions will focus on teaching parents strategies for enhancing their child's social engagement and communication. Since parents will be using these strategies across all activities throughout the day, there is an increased likelihood of generalization. For parents of minority and underserved children, this may be the first exposure to responsive interaction strategies (Rudy \& Grusec, 2001).

Study groups in NCT01008800
Study groupRoleWhat they receive
Center-Based classroom interventionExperimentalFour days a week for 2.5 hours a day the child will participate in a classroom with peers in an attempt to increase social communication, language abilities, and other skills. Parents will also receive education sessions 1-3 times per month for 1-2 hours each. Treatment will last for 6 months.
Receives: Behavioral: Social Communication
Parent TrainingActive comparatorParents are taught strategies on how to interact with their children to increase their skills. Parent training sessions are given 2 times a month at our center and once a month at home for 60-90 minutes each. Treatment will last for 6 months.
Receives: Behavioral: Social communication

What is being measured

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

  1. Communication and Symbolic Behavior Scales

    Measured: immediately after treatment ends and 6 months after treatment ends

Secondary outcomes (1)

  1. Mullen Scales of Early Learning

    Measured: immediately after treatment ends and 6 months after 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 posted6 Nov 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

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
None (open label)
Enrolment
196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008800
Sponsor's protocol ID
R40 MC 15594-01
Other IDs
NA_00030329
Status last verified
Mar 2021
First submitted
5 Nov 2009
Last updated
10 Mar 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Sofronoff K, Farbotko M. The effectiveness of parent management training to increase self-efficacy in parents of children with Asperger syndrome. Autism. 2002 Sep;6(3):271-86. doi: 10.1177/1362361302006003005.

    PubMed 12212918

  • Tannock R, Girolametto L, Siegel LS. Language intervention with children who have developmental delays: effects of an interactive approach. Am J Ment Retard. 1992 Sep;97(2):145-60.

    PubMed 1384566

  • McGee, G. G., Morrier, M. J., & Daly,T. (1999).An incidental teaching approach to early intervention for toddlers with autism. Journal of the Association for Persons with Severe Handicaps, 24, 133-146.

  • Rutter M. Diagnosis and definition of childhood autism. J Autism Child Schizophr. 1978 Jun;8(2):139-61. doi: 10.1007/BF01537863. No abstract available.

    PubMed 670129

  • Kasari C, Freeman S, Paparella T. Joint attention and symbolic play in young children with autism: a randomized controlled intervention study. J Child Psychol Psychiatry. 2006 Jun;47(6):611-20. doi: 10.1111/j.1469-7610.2005.01567.x.

    PubMed 16712638

Questions about this trial

What is this clinical trial studying?

A study testing Social Communication 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 8 inclusion and 13 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?

Communication and Symbolic Behavior Scales (time frame: immediately after treatment ends and 6 months after treatment ends). 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 NCT01008800, which also lists 5 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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