Speech Intervention Via Telepractice for Children With Repaired Cleft Palate: Randomized Controlled Trial and Assessment of Speech Production and Perception Skills
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in percent correct for the target sound in words during post-treatment in Face-to-Face and Teletherapy interventions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Telepractice Group
Speech therapy delivered through telepractice modality
干预措施: Speech therapy (Behavioral)
Face-to-Face Group
speech therapy delivered through face-to-face home health modality
干预措施: Speech therapy (Behavioral)
结局指标
主要结局
Change in percent correct for the target sound in words during post-treatment in Face-to-Face and Teletherapy interventions
时间窗: 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).
次要结局
- Change in percent correct for the target sound in sentences post-treatment in Face-to-Face and Teletherapy interventions(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).)
研究者
Sue Ann Lee
Professor, Director of Cleft Palate and Craniofacial Anomaly Clinic
Texas Tech University Health Sciences Center