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

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Old Dominion University
Study ID
NCT07219901
Status
Not Yet Recruiting

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Conditions

  • Cleft Lip Palate
  • Cleft Lip and Cleft Palate
  • Cleft Lip and/or Palate
  • Cleft Palate
  • Cleft Palate Children
  • Cleft Palate Repair
  • Cleft Palates

Eligibility Criteria

Sex
ALL
Age
6 Months - 12 Months
Healthy Volunteers
Not accepted

Interventions

  • Early intervention for language, articulation and palatal function skills — 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

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.

Key Dates

Start date
Oct 21, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    All participants will be allocated to this arm; they will receive the intervention as detailed elsewhere in this protocol.

Primary Outcome Measure

MBCDI (W&G) [ Time Frame: From enrollment to the end of treatment at 8 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Old Dominion UniversityNorfolkVirginia23529
Victoria Reynolds, LLB BSc PhD
[email protected]
551-202-1970

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By research site
Old Dominion University· Norfolk, VA

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