Speech Intervention Via Telepractice for Children With Repaired Cleft Palate

NCT07434375 | Not Yet Recruiting DMC

• 1 other identifier: NIDCR Protocol 23-029-E
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Palate Children; Speech Sound Disorder

Keywords

non-inferiority; telepractice; speech therapy; intervention; speech perception; speech production; cleft palate; children

Outcome Measures

Primary Outcomes (1)

• Change in percent correct for the target sound in words during post-treatment in Face-to-Face and Teletherapy interventions

  We will check speech accuracy using 16 test words or sounds for each target. To see how much someone improves, we will compare how many they say correctly after therapy to how many they said correctly before therapy. We calculate improvement by subtracting the number correct before therapy from the number correct after therapy, dividing that number by the total number of attempts, and then multiplying by 100 to get a percentage. Finally, we will compare the improvement percentages between the group that receives therapy online (telepractice) and the group that receives therapy in person (face-to-face).

  Speech accuracy will be measured two times during the study: (1) about 1-2 weeks before therapy begins (this is the starting or baseline visit); (2) about 1 week after therapy ends (this is the final study visit).

Secondary Outcomes (1)

• Change in percent correct for the target sound in sentences post-treatment in Face-to-Face and Teletherapy interventions

  Speech accuracy will be measured two times during the study: (1) about 1-2 weeks before therapy begins (this is the starting or baseline visit); (2) about 1 week after therapy ends (this is the final study visit).

Other Outcomes (3)

• Change in percent correct of perception of the target sound in words post-treatment in Face-to-Face and Teletherapy interventions

  Accuray of perceiving speech sounds will be administered two times during the study: (1) about 1-2 weeks before therapy begins (this is the starting or baseline visit); (2) about 1 week after therapy ends (this is the final study visit).

• Change in ratings of the Intelligibility in Context Scale post-treatment in Face-to-Face and Teletherapy interventions

  Intelligibility in Context Scale will be administered two times during the study: (1) about 1-2 weeks before therapy begins (this is the starting or baseline visit); (2) about 1 week after therapy ends (this is the final study visit).

• Change in the F-ratio of the 's' and 'sh' consonants post-treatment in Face-to-Face and Teletherapy interventions

  Acoustic values (F-ratio) will be assessed two times during the study: (1) about 1-2 weeks before therapy begins (this is the starting or baseline visit); (2) about 1 week after therapy ends (this is the final study visit).

Study Arms (2)

Telepractice Group

ACTIVE COMPARATOR

Speech therapy delivered through telepractice modality

Behavioral: Speech therapy via teleprace

Face-to-Face Group

PLACEBO COMPARATOR

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

Behavioral: Face-to-face speech therapy

Interventions

Speech therapy via teleprace BEHAVIORAL

Children with cleft palate will participate in 30-minute speech therapy sessions twice a week for 10 weeks

Telepractice Group

Face-to-face speech therapy BEHAVIORAL

Children with cleft palate will receive treatment maintaining the same frequency as the intervention group.

Face-to-Face Group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Speech Sound Disorder; Communication Disorders; Cleft Palate

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Chadley Copeland, MPA, MEd, CCRP

CONTACT

8067434752; chadley.copeland@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Cleft Palate and Craniofacial Anomaly Clinic

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 25, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Available from February 2030 to February 2035.

Locations

US (1)