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Cleft Lip and Cleft PalateNewbornBehavioralChildren's healthBehavioral

What this study is

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.

What's being tested

  • Early intervention for language, articulation and palatal function skills

    Intervention · BEHAVIORAL

    This 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.

Study details

Sponsor
Old Dominion University
Conditions
Cleft Lip and Cleft Palate · Cleft Lip Palate · Cleft Lip and/or Palate · Cleft Palate · Cleft Palate Children · Cleft Palates · Cleft Palate Repair
Enrolling
200 people
Starts
2025-10-21
Est. completion
2027-01-31
Design
Open-label, single group
Record
View on ClinicalTrials.gov ↗