Speech Intervention Via Telepractice for Children With Repaired Cleft Palate

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-11
SponsorTexas Tech University Health Sciences Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Speech therapy via teleprace

    Behavioral

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

  • Face-to-face speech therapy

    Behavioral

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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Telepractice GroupActive comparator 1 intervention
Group B: Face-to-Face GroupPlacebo comparator 1 intervention

Trial outcomes

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).

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).

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.

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).

Other outcomes

1

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.

Time frame
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).
2

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).

Time frame
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).
3

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.

Time frame
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).

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