Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorOld Dominion University

About this trial

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.

Eligibility criteria

Qualifiers

Infants with unrepaired cleft palate (with or without cleft lip)

Aged between 6 and 10 months at the time of study commencement

Disqualifiers

Medically fragile status that would preclude participation in this community-based study.

Palatoplasty completed.

Aged over one year

Infants with cleft lip only

Trial design

Treatments tested in this trial

  • Early intervention for language, articulation and palatal function skills

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Old Dominion University

Lead sponsor

Children's Hospital of The King's Daughters

Collaborator