Cleft Palate ChildrenNCT07434375
Speech Intervention Via Telepractice for Children With Repaired Cleft Palate
A study testing Speech therapy via teleprace and Face-to-face speech therapy in people with Cleft Palate Children and Speech Sound Disorder, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Cleft Palate Children, Speech Sound Disorder
- What is being tested?
- Speech therapy via teleprace and Face-to-face speech therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Sue Ann Lee, Ph.D
About this study
Official title: 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.
Read more
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
- Being tested
- Speech therapy via teleprace, Face-to-face speech therapy
- Keywords
- non-inferiority, telepractice, speech therapy, intervention, speech perception, speech production, cleft palate, children
- Medical subject headings
- Speech Sound Disorder, Communication Disorders, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech therapy via telepraceBehavioural
Children with cleft palate will participate in 30-minute speech therapy sessions twice a week for 10 weeks
Face-to-face speech therapyBehavioural
Children with cleft palate will receive treatment maintaining the same frequency as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Telepractice Group | Active comparator | Speech therapy delivered through telepractice modality Receives: Behavioral: Speech therapy via teleprace |
| Face-to-Face Group | Placebo comparator | Speech therapy delivered through face-to-face home health modality Receives: Behavioral: Face-to-face speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Palate ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Ann Lee, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434375
- Sponsor's protocol ID
- NIDCR Protocol 23-029-E
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Intervention Via Telepractice for Children With Repaired Cleft Palate: Randomized Controlled Trial and Assessment of Speech Production and Perception Skills
- ClinicalTrials.gov ID
- NCT07434375
- Acronym / sponsor ID
- NIDCR Protocol 23-029-E
- Conditions
- Cleft Palate Children, Speech Sound Disorder
- Keywords
- non-inferiority, telepractice, speech therapy, intervention, speech perception, speech production, cleft palate, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telepractice Group | Active comparator | Behavioral: Speech therapy via telepraceSpeech therapy delivered through telepractice modality |
| Face-to-Face Group | Placebo comparator | Behavioral: Face-to-face speech therapySpeech therapy delivered through face-to-face home health modality |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech therapy via telepraceChildren with cleft palate will participate in 30-minute speech therapy sessions twice a week for 10 weeks | Behavioural | Telepractice Group |
| Face-to-face speech therapyChildren with cleft palate will receive treatment maintaining the same frequency as the intervention group. | Behavioural | Face-to-Face Group |
Primary outcome
Change in percent correct for the target sound in words during post-treatment in Face-to-Face and Teletherapy interventions
Time frame: 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).
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).
1 secondary outcome
Change in percent correct for the target sound in sentences post-treatment in Face-to-Face and Teletherapy interventions
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. 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
Related trials for Cleft Palate Children
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Recruiting
Expiratory Muscle Strength Training for Hypernasal Speech in Children
Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate
Enrolling by invitation
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
Cleft Palate +/- Lip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech therapy via teleprace and Face-to-face speech therapy in people with Cleft Palate Children and Speech Sound Disorder, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chadley Copeland, MPA, MEd, CCRP (8067434752, chadley.copeland@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent correct for the target sound in words during post-treatment in Face-to-Face and Teletherapy interventions (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.