Speech Intervention Via Telepractice for Children With Repaired Cleft Palate

Texas Tech University Health Sciences Center

Status: Not yet enrolling

Conditions: Cleft Palate Children; Speech Sound Disorder

Treatments: Behavioral: Face-to-face speech therapy; Behavioral: Speech therapy via teleprace

Study type: Interventional

Funder types: Other

Identifiers

NCT07434375

NIDCR Protocol 23-029-E

Details and patient eligibility

About

The goal of this interventional study is to see if online speech therapy works just as well as face-to-face speech therapy in children with cleft palate. The main purposes are:

To compare the speech accuracy of target sounds in words produced by children with cleft palate between online and face-to-face speech therapy.

To compare the gain in speech accuracy in sentences produced by children with cleft palate between online and face-to-face speech therapy.

To assess whether changes in speech intelligibility are perceived by parents. To explore what kinds of factors influence speech accuracy. To explore speech training accuracy and speech understandability training accuracy during speech therapy sessions in children with CP

Participants will participate in 30-minute speech intervention sessions twice a week for 10 weeks, either in-person or online.

Enrollment: 64 estimated patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Within the ages 5;0 and 11;11 (years; months) at enrollment and for enrollment duration
• Having normal hearing based on a pure-tone hearing screening at 20 dB HL bilaterally at 500, 1000, 2000 and 4000Hz. Children with a history of hearing loss or children who currently are properly equipped with amplification will be included if they pass the hearing screening
• Having typical nonverbal IQ, language, and socioemotional function as determined by a T-score with no more than -1.5 SD from the mean on Kauffman Brief Intelligence Test-2 (KBIT-2), receptive language of Clinical Evaluation Language Fundamentals-5 (CELF-5 Core Language), and Childhood Autism Rating Scale-2 (CARS-2)
• Having a speech sound disorder as determined by a score ≤ 30th percentile on the Goldman-Fristoe Test of Articulation-3 (GFTA-3)
• Demonstrate a cleft-related or a phonological error on at least one phoneme. For the sound, a cleft-related or a phonological error appears at word-initial phoneme on any two of the following tests; single words on GFTA-3, American English Phrase Samples (AEPS) and Sentence Sample (AESS) on the CAPS-A AM
• Willing to comply with all study procedures and availability for the study duration.

Exclusion criteria

• Demonstrates a medically diagnosed sensory or neurological disorder based on parents' report
• Presents with velopharyngeal insufficiency (VPI) due to structural anomalies or an oronasal fistula
• English is not the primary language spoken at home. Bilingual children will not be excluded.
• Children who do not demonstrate cleft speech characteristics.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups, including a placebo group

Telepractice Group

Active Comparator group

Description:

Speech therapy delivered through telepractice modality

Treatment:

Behavioral: Speech therapy via teleprace

Face-to-Face Group

Placebo Comparator group

Description:

Speech therapy delivered through face-to-face home health modality

Treatment:

Behavioral: Face-to-face speech therapy