| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21211 |
| Conditions: |
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Autism |
| Purpose: |
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The goal of this project is to compare the efficacy of two interventions for improving
spoken language and reducing symptoms of autism.
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| Study summary: |
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While significant progress has been made toward identifying effective interventions for
preschool-age children with autism (National Research Council, 2001), few scientifically
rigorous studies have compared active ingredients of these interventions or examined
outcomes focused on core deficits. To address these areas of need, this collaborative,
multi-site project combines the expertise of investigators experienced in randomized
controlled clinical trials (RCTs), in the study of core deficits in young children with
autism, and in data management and analysis of multi-site clinical trials.
The goal of this project is to compare the efficacy of two interventions for improving
spoken language and reducing symptoms of autism: (1) Discrete trial training (DTT)--an
applied behavior analysis approach emphasizing highly structured teaching of school
readiness skills (match-to-sample, imitation, functional play, and receptive and expressive
language) and (2) Interpersonal developmental approach (IDA): a visually supported,
child-focused, flexible engagement, social communicative engagement approach on joint
attention, symbolic play, and the use of conventional symbols within socially valid
communicative contexts.
Children will be randomly assigned to DTT or IDA. In each condition, children's ongoing
early intervention programs will be augmented with two 30-minute sessions daily of the study
intervention (DTT or IDA) conducted by supervised therapists for 4 months, with transition
to home therapy for 2 months.
Potential moderators (e.g., initial mental age and language age) and mediators (e.g. parent
synchronization of joint attention and changes in parental expectancies) on treatment
outcome will also be examined.
The assessment measures will include diagnostic and developmental measures. There are three
sets of assessments. The first set of assessments is to determine whether the child is
eligible for the study. If the child is eligible, we will complete the next set of
assessments, which are completed at three points: (1) prior to entry into the treatment
(this is a baseline measurement conducted just before the start of the treatment phase);
(2) at exit; and (3) at a 6 month follow-up. Several assessments will also be completed
after 2 months, 4 months, and 6 months. |
| Criteria: |
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Inclusion criteria:
1. Diagnosis of an autism spectrum disorder (Autistic Disorder or Pervasive
Developmental Disorder Not Otherwise Specified) from a licensed doctoral-level
clinician, confirmed by the Autism Diagnostic Observation Schedule and clinical
judgment.
2. Chronological age between 33 and 54 months
3. Must be receiving at least 12.5 hours per week of early intervention or preschool
developmental services, some of which must be provided in a school setting.
4. Cognitive and language requirements (at least two of the following three criteria
must be met:
- >12 months for visual reception (as determined by Mullen Scales of Early
Learning) or receptive language (as determined by Mullen or Reynell
Developmental Language Scales)
- a score of 1,2 or 3 on the ADOS Module 1
- <30 spontaneous communicative words, as determined by behavior assessments
(Mother- Child Interaction, Early Social Communication Scales, and Structured
Play Assessment)
Exclusion criteria:
1. Major medical conditions other than autism, specifically (a) genetic disorders such
as Fragile X, Down syndrome, or tuberous sclerosis, (b) sensory disabilities such as
blindness or deafness, and (c) motor disabilities such as cerebral palsy
2. Nonverbal mental age < 12 months, based on a nonverbal score from the Mullen Scales
of Early Learning (Mullen, 1995), as reliability of a diagnosis of autism is
questionable at this developmental level.
3. Expressive language level that exceeds the First Words level, as evidenced by an age
equivalent of 24 months or greater on the Expressive Language Scale of the Reynell
4. Exposure to English less than 50% of the time |
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| Study is available at: |
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Kennedy Krieger Institute
Baltimore, MD 21211
United States
Primary Contact:
Rebecca Landa, PhD, CCC-SLP
Email: zimmermanr@kennedykrieger.org
Phone: 443-923-7680
Secondary Contact:
Connie Kasari, PhD
Email: kasari@geis.ucla.edu
Phone: 310-825-8342 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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