Speech Intervention Via Telepractice for Children With Repaired Cleft Palate

Browse trials for

• Speech Sound Disorder 46
• Communication Disorders 149
• Cleft Palate 123

Keywords

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

Speech Sound Disorder

46 studies on the registry are indexed under Speech Sound Disorder; 16 are open to participants now.

This study's planned enrollment of 64 is above the median of 40 across 39 interventional studies indexed under Speech Sound Disorder.

Lead sponsor

Texas Tech University Health Sciences Center is the lead sponsor of 100 studies on the registry; 14 are open to participants now.

Study arms

• Active comparator
  Telepractice Group

  Speech therapy delivered through telepractice modality

  Behavioral: Speech therapy via teleprace

• Placebo comparator
  Face-to-Face Group

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

  Behavioral: Face-to-face speech therapy

Interventions

• BehavioralSpeech therapy via teleprace

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

• BehavioralFace-to-face speech therapy

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

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).

Individual participant data

Plan to share: 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

Supporting information: Clinical study report

Time frame: Available from February 2030 to February 2035.