This study proposes to evaluate the effectiveness of an early intervention for children with cleft lip and palate to facilitate speech and vocabulary development and prevent the habituation of compensatory articulation use in Brazil. This research will be conducted at the Hospital for Rehabilitation for Craniofacial Anomalies-University of Sao Paulo-Bauru in collaboration with Dr. Inge Trindade with the companion grant of Dr. Nancy Scherer, R21DC009654, and 7-1-2009 to 6-30-2011. This application will utilize methodology, training manuals and modules developed as part of an R21 that is assessing the efficacy of the Enhanced Milieu Teaching with Phonological Emphasis (EMT/PE) for young children with CLP in the US in a randomized comparison with a traditional speech intervention.
The specific aims of the proposed investigation will: 1) Translate intervention training components of EMT/PE into Portuguese and develop a protocol for video demonstration of EMT/PE, 2) Train Speech-Language Pathologists and graduate students at Hospital for Rehabilitation of Craniofacial Anomalies-University of Sao Paulo (HRCA-USP) in EMT/PE. Three SLP's at HRCA-USP-Bauru and 2 satellite clinics in the Sao Paulo area and Rio Grande do Sul will be trained to reliably conduct the EMT/PE. Graduate students in speech-language pathology at HRCA-USP and East Tennessee State University will be trained in research methodology associated with the EMT/PE project, and 3) Conduct a group study with random assignment to an EMT/PE intervention treatment or a business as usual control group to assess the delivery of the EMT/PE intervention for children with CLP in Brazil. The study will examine 24 children with nonsyndromic cleft lip and/or palate at three time points; pre-treatment, (T0) immediately following treatment (T1) and 3 months following treatment (T2). Speech and language outcome measures to be assessed in the evaluations and during the intervention include vocabulary measures from parent report and language sample (i.e., the number of different words), vocalization rate, turn-taking and parent word use at home (LENA) and speech measures (i.e., consonant inventory, intelligibility rating, percent consonants correct, and percent of compensatory articulation use). The data will be analyzed using the difference-in-differences (DID; Ashenfelter & Card, 1985) approach to test for treatment effects and maintenance of treatment effects. The gains observed in the treated children will be contrasted against any gains observed in the control children.
The incidence of cleft lip and palate (CLP) is 1:600 births worldwide and presents a significant social stigmata and health risk for children in developing countries. Communication deficits are a primary contributor to the long term outcome for children with CLP due to speech and language delays associated with structural deficits. There has been significant progress in training physicians in emerging nations to provide early surgical intervention. And many countries, including Brazil, are turning their attention to developing speech and language intervention models for their children. This study proposes to evaluate the effectiveness of an early intervention for children with cleft lip and palate to facilitate speech nd vocabulary development and prevent the habituation of compensatory articulation use. This study will be conducted at Hospital for Rehabilitation of Craniofacial Anomalies- University of Sao Paulo; Bauru, Brazil and satellite clinics in Sao Paulo and Rio Grande do Sol. This application will utilize methodology and training developed as part of Principal Investigator's R21 that is assessing the efficacy of the Enhanced Milieu Teaching with Phonological Emphasis (EMT/PE) for young children with CLP in the US. The proposed investigation will translate intervention training components of EMT/PE into Portuguese and train Speech-Language Pathologists and graduate students at Hospital for Rehabilitation of Craniofacial Anomalies-University of Sao Paulo (HRCA-USP) in EMT/PE. This study will examine 24 children with CLP in a repeated-measures design with random assignment to treatment and selection of matched control subjects across 3 time points prior to intervention (T0), post treatment (T1) and 3 months after treatment (T2). The study will be conducted at HRCA-USP and two satellite clinics, San Bernardo (near Sao Paulo) and Rio Grande do Sol, Brazil to assess the delivery of the EMT/PE intervention for children with CLP. This study has the potential to impact the early speech and language development of a group of children with cleft palate who experience significant early speech and language deficits despite aggressive early surgical intervention. Further, information and training on early intervention for children with CLP will be disseminated through development of an innovative early intervention training website and online training in Portuguese hosted by USP-Sao Paulo.
