The goal of this clinical trial is to learn if teaching speech skills to infants with cleft palates, prior to palate repair, will help them to develop speech and language skills. It will also learn about whether the skills are linked to fewer speech sound difficulties when they start school. The main questions it aims to answer are:
Do standard, early intervention techniques to promote language development, that are used in children who are late talkers, work in infants with cleft palates? Will infants with cleft palates increase the number of sounds they use after targeted intervention? Can infants attempt to make stop sounds, like b and p, after targeted intervention? Can infants with cleft palate learn new words more quickly when they are used with gestures?
Participants will:
Participate in a baseline evaluation of speech and language skills, either in person, or via Telehealth.
Attend the clinic for twice-weekly visits, for six weeks, to learn techniques to help their infants develop their speech and language skills, in a group setting with other families of infants with cleft palate.
Participate in a final evaluation of speech and language skills, either in person, or via Telehealth.
Infants with unrepaired cleft palate (with or without cleft lip)
Aged between 6 and 10 months at the time of study commencement
Medically fragile status that would preclude participation in this community-based study.
Palatoplasty completed.
Aged over one year
Infants with cleft lip only
Single group
Early intervention for language, articulation and palatal function skills
BehavioralThis intervention will use the principles of focused stimulation, and enhanced milieu teaching, to coach families in the following speech and language development strategies: attempting oral plosives, increasing phonetic inventory, mapping words to gesture use, and promoting canonical babbling.
MBCDI (W&G)
Number of words and concepts, as measured by the MacArthur-Bates Communicative Development Inventory (Words and Gestures)
Plosive attempts
Attempts at oral plosive phonemes
Phonemes
Number of different phonemes spontaneously produced by the infant.
Canonical babbling: frequency
Frequency of canonical babbling will be measured by counting the number of canonical babblings produced by the infant in a ten-minute, caregiver-infant interaction.
Canonical babbling: shape
Shape of canonical babbling will be measured by recording and phonotactically transcribing the syllable shapes of canonical babbling observed during a ten-minute caregiver-infant interaction. The number of different shapes will be calculated.
Caregiver confidence
Each Q will be rated on a scale of 0 - 10: 0 = complete absence, 10 = full confidence. The total score will be calculated from the sum of scores for each question. How confident are you: Practicing language development strategies with your child? Knowing how your child should be playing for their age? Engaging in communication with your child (e.g., face-to-face, playing with a ball)? Taking turns with your child, in conversation (e.g., baby makes a sound, you repeat the sound) and play (e.g., you roll the ball, they roll the ball)? Knowing how your child should be babbling for their age? Knowing which sounds are impacted by having a cleft palate? Redirecting your child when they use throat sounds? Interpreting your child's gestures? Connecting their gestures to their/your spoken words? Promoting lip and tongue movements in your child? Helping your child to make new sounds? Overall, in supporting your child's speech and language development?
Conversational turn-taking: length of conversational utterance
Increase the length of conversational turn-taking in infant-caregiver interactions. Conversational turns, within a ten minute period, will be measured with a stopwatch. This value (length) will be calculated from the mean (or median, depending on data distribution) duration of the caregiver's conversational turn, in seconds.
Conversational turn-taking: frequency of conversational utterance
Increase the frequency of conversational turn-taking in infant-caregiver interactions. Conversational turns, within a ten minute period, will be counted. The total number of conversational turns will be used as the outcome measure.
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Old Dominion University
Lead sponsor
Children's Hospital of The King's Daughters
Collaborator
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