Effects of Intensity of Early Communication Intervention

Study Overview
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Brief Summary
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The purpose of the study is to determine if a more intensive application of communication intervention, i.e. 5 hours per week, will result in more frequent intentional communication acts, greater lexical density, and a better verbal comprehension level than children who receive the same communication intervention only one time per week.

Detailed Description
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Our research team has pioneered the development of a prelinguistic communication intervention referred to as Parent Responsivity Education-Milieu Communication Teaching (PRE-MCT). This intervention is designed to establish and enhance the development of intentional communication prior to the onset of spoken language in children with language delays and disorders. In the early stages of intervention, clinicians target children's use of gestures, vocalizations, and eye contact to produce more frequent and more complex nonverbal communication acts. As the children develop, goals shift to the direct teaching of words and sentence structures. Our preliminary research using randomized experimental designs has tested the effects of the intervention when delivered in a very small 'dose', averaging just over one hour per week for six months. This standard dose has led to significant but modest effects in the children's use of intentional communication and early language, such that it could be adopted by speech-language pathologists as part of standard care. Unfortunately, the early benefits have not always been maintained 6 and 12 months after the therapy phase ends and have not always benefitted all children. This research is a test of the hypothesis that a more intensive application of the intervention will have dramatically more positive outcomes than the standard dosage.

Official Title
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Effects of Intensity of Early Communication Intervention

Conditions
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Communication Disorders, Developmental Disabilities

Intervention / Treatment
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* Behavioral: Milieu Communication Teaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must produce at least one intentional communication act during administration of the Communication and Symbolic Behavior Scale a minimum raw score of 34 or a composite score not greater than 75 on the cognitive subtest of the Bayley Scales of Infant Development Exclusion Criteria: spontaneous production of more than 20 words failure of a screening test for Autism English is not the primary language spoken in the home corrected hearing or corrected vision is not within normal limits

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 27 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Intensity<br>One hour of intervention per week | Behavioral: Milieu Communication Teaching<br>* Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week<br>* Other names: Parent Responsivity Education-Milieu Communication Teaching;|
| Experimental: High Intensity<br>Five hours of intervention per week, one hour per day for five days per week | Behavioral: Milieu Communication Teaching<br>* Communication intervention targeting intentional communication and language skills provided either one hour per week or one hour per day, five days per week<br>* Other names: Parent Responsivity Education-Milieu Communication Teaching;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of intentional communication, lexical density (observational), and vocabulary (parent report) |  | Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental stress level |  | Pre-treatment and post-treatment | 
| Parental responsivity |  | Pre-treatment, at 3 months, 6 months, 9 months, and 15 months post enrollment |