Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)



Status:Completed
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:11/22/2018
Start Date:January 2008
End Date:December 2011

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A Comprehensive Approach to Intervention for Toddlers at Risk for ASD

This research is being done to test the effectiveness of an early intervention model for very
young children at high risk for autism spectrum disorders (ASD) and their families. If
children show improvement in this intervention, the investigators hope that the availability
of public services of this type will be increased. Children between 11 months and 21 months
old with Autism Spectrum Disorders, or with social and communication delays that indicate
high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must
start prior to the second birthday.


Inclusion Criteria:

- Children will be ascertained between 11 months and 21 months of age

- Must be able to enter the study prior to their second birthday

- Must then pass an eligibility assessment to determine whether the child meets criteria
for ASD and thus qualifies for the study. This assessment will consist of the Baby
ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or
autism on the ADOS, score more than one standard deviation below the mean on the
Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of
ASD to be eligible for enrollment into treatment.

- 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
Enrichment/Training condition must agree to attend the training sessions

Exclusion Criteria:

- Fail hearing or vision screening (by pediatrician's office, audiologist, or
ophthalmologist)

- Family's first language being other than English (language measures are normed on
English speakers, putting non-English speakers at a disadvantage. In addition, the
treatment is delivered in English. Children from non-English speaking homes may not
make progress, but for reasons other than the efficacy of the intervention.)

- Head injury (because this may cause some of the symptoms, which may not be due to
autism and therefore we would not be able to assess the effects of the intervention on
autism)

- Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous
Sclerosis)

- Inability of the family to attend the playgroup sessions and parent trainings

- Parents whose hearing or vision is not within normal limits after correction (e.g.,
hearing aid, glasses)

- Parents with developmental delays, language or learning impairments, or a psychiatric
diagnosis IF the impairment would interfere with parent training (PI will assess on a
case by case basis by talking to the parent)

- Foster children

- Refusal to allow videotaping of the children's assessments or intervention or to allow
videotaped footage to be used for teaching purposes.
We found this trial at
1
site
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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mi
from
Baltimore, MD
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