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Clinical Trials/NCT01012076
NCT01012076
Completed
Not Applicable

Promoting Development in Toddlers With Communication Delays

Autism Speaks2 sites in 1 country60 target enrollmentApril 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Autism Speaks
Enrollment
60
Locations
2
Primary Endpoint
Maternal Synchronization
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Eighty parent-child dyads will be recruited and randomly assigned to either the experimental intervention or an active control condition. Subjects assigned to the experimental group will participate in 12 home-based intervention sessions.

Detailed Description

The experimental intervention is manualized, follows an illustrated workbook for parents, and uses individualized video-feedback, modeling, and coaching strategies to help parents establish play interactions that promote communication. All participants take part in comprehensive baseline and post-intervention/post-active control assessments, as well as 6- and 12-month follow up assessments. Families in the active control group will also be invited to participate in an oral feedback session to discuss the results from these assessments. Children's involvement in other forms of intervention will be monitored using a validated intervention log so that the moderating effects of these treatments can be examined. By targeting parent-child interactions, the current intervention ensures that new child behaviors generalize beyond the immediate context of the intervention and are maintained over time (Schreibman, 2000). In addition, by involving parents in the treatment of their children (e.g., by establishing a daily playtime routine), the current intervention ensures that the intervention strategies are implemented with sufficient intensity for causing developmental change (National Research Council, 2001).

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
October 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • The child is between 15 and 30 months of age;
  • The child scores at least one standard deviation below average on the Social Composite Score of the CSBS DP.

Exclusion Criteria

  • The child has been diagnosed with a known medical condition that has been linked to either autism or mental retardation (e.g., Fragile X, Tuberous Sclerosis, Cerebral Palsy, Hydrocephalus).
  • The child has a severe visual, hearing, or motor impairment or fragile health condition that would prevent him/her from validly participating in the assessment procedures.

Outcomes

Primary Outcomes

Maternal Synchronization

Time Frame: 12 months

Maternal Synchronization will be measured at 12 month follow up of study.

Secondary Outcomes

  • Early Social Communication Scale(12 months)

Study Sites (2)

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