Speech Intervention Via Telepractice for Children With Repaired Cleft Palate

Speech Intervention Via Telepractice for Children With Repaired Cleft Palate: Randomized Controlled Trial and Assessment of Speech Production and Perception Skills

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cleft Palate Children; Speech Sound Disorder
• Intervention / Treatment: Behavioral: Speech therapy via teleprace; Behavioral: Face-to-face speech therapy

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chadley Copeland, MPA, MEd, CCRP; Phone Number: 8067434752; Email: chadley.copeland@ttuhsc.edu

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center
      • Principal Investigator: Sue Ann Lee, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Telepractice Group; Speech therapy delivered through telepractice modality	Behavioral: Speech therapy via teleprace; Children with cleft palate will participate in 30-minute speech therapy sessions twice a week for 10 weeks
Placebo Comparator: Face-to-Face Group; Speech therapy delivered through face-to-face home health modality	Behavioral: Face-to-face speech therapy; Children with cleft palate will receive treatment maintaining the same frequency as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent correct for the target sound in sentences post-treatment in Face-to-Face and Teletherapy interventions	Speech accuracy will be measured using 16 sentences for each target sound or speech goal. To calculate improvement, we will compare the number of sentences said correctly after therapy to the number said correctly before therapy. We subtract the "before" score from the "after" score, divide by the total number of attempts, and multiply by 100 to get a percentage improvement.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent correct of perception of the target sound in words post-treatment in Face-to-Face and Teletherapy interventions	Perceptual accuracy (how correctly a child hears specific sounds or words) will be measured using 24 words for the target sound. To calculate improvement, we will compare the number of words correctly identified as correct or incorrect after therapy to the number of words correctly identified before therapy. We subtract the "before" score from the "after" score, divide by the total number of attempts, and multiply by 100 to get a percentage improvement. Each child's overall improvement score will then be calculated by averaging their results across targets.	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	Functional outcomes (how well a child is understood in everyday situations) will be measured using the Intelligibility in Context Scale (ICS). This is a short questionnaire completed by parents about how easily their child is understood by different people. Improvement will be calculated by comparing the parent ratings after therapy to the ratings before therapy. The difference between these two scores will show how much progress was made. We will compare results between children who received therapy online (telepractice) and those who received therapy in person (face-to-face).	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	We will measure how clearly children distinguish between the "s" sound (/s/) and the "sh" sound (/ʃ/) in different vowel contexts. To do this, children will repeat made-up words that follow a simple pattern (consonant-vowel-b), such as "soob." These words will include three different vowels: "ee" (i), "ah" (a), and "oo" (u). Each word will be said within a short sentence, such as "It's the soob again," during a repetition task. We will use a sound measurement called an F-ratio to compare the acoustic differences between the "s" and "sh" sounds for each vowel. This ratio is calculated by comparing the median frequency values of the two sounds within each vowel context. The overall F-ratio results for all participants combined will then be compared from before therapy (pre-test) to after therapy (post-test) to see whether the contrast between the sounds improved.	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).

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: children; cleft palate; intervention; speech therapy; non-inferiority; telepractice; speech perception; speech production
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Mental Disorders; Jaw Diseases; Neurobehavioral Manifestations; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Neurodevelopmental Disorders; Mouth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Communication Disorders; Cleft Palate; Speech Sound Disorder; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Speech Therapy
• Other Study ID Numbers: NIDCR Protocol 23-029-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central immediately upon acceptance for publication. This ensures that the public has access to the published results of NIH-funded research.

In addition to disseminating data generated from this study in peer-reviewed journals and professional conferences, an integral part of this proposed research is the plan to share outcomes generated from this study with the public to facilitate clinical practice and research. We will share our data, knowledge, and technical outcomes gained through the completion of the proposed study in compliance with the NIH Data Sharing Policy.

All data to be shared will be de-identified before sharing to ensure that participant's privacy is fully protected. Findings from this research have the potential to be immediately informative to speech-language pathologists, special education teachers, parents, and researchers workin

• IPD Sharing Time Frame: Available from February 2030 to February 2035.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No