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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07434375
Enrollment
64
Registered
2026-02-25
Start date
2026-03-02
Completion date
2029-01-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate Children, Speech Sound Disorder

Keywords

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

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.

Interventions

BEHAVIORALFace-to-face speech therapy

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

BEHAVIORALSpeech therapy via teleprace

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

Sponsors

Texas Tech University Health Sciences Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in percent correct for the target sound in words during post-treatment in Face-to-Face and Teletherapy interventionsSpeech 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).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).

Secondary

MeasureTime frameDescription
Change in percent correct for the target sound in sentences post-treatment in Face-to-Face and Teletherapy interventionsSpeech 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).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.

Countries

United States

Contacts

CONTACTChadley Copeland, MPA, MEd, CCRP
chadley.copeland@ttuhsc.edu8067434752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026