Teletherapy to Address Language Disparities in Deaf and Hard-of-hearing Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 10
- 主要终点
- PLS-5 Auditory Comprehension (AC) Standard Score - 18 month
研究概览
简要总结
This study seeks to determine the effectiveness of speech/language teletherapy to address disparities in speech and language outcomes in children who are deaf or hard-of-hearing (D/HH). The investigators will enroll D/HH children aged 0-27 months. 140 children who are publicly insured will be randomized to receive usual clinical care or to be given access to an 18-month course of speech-language teletherapy program. 70 children who are privately insured will also be enrolled and will receive usual care. Children will undergo, at baseline and every 9 months thereafter to a study endpoint of 18 months, for a total of 3 timepoints, a battery of in-person and parent-report assessments designed to provide a comprehensive measurement of the child's auditory function, speech, verbal- and non-verbal communication, spoken language, and quality of life.
详细描述
210 children aged 0-27 months with confirmed permanent hearing loss will be recruited from Otolaryngology/Audiology clinics at multiple pediatric hospitals. All provide care for a broadly diverse D/HH population for the disparities of interest. Children who come into Otolaryngology/Audiology clinics will be screened for eligibility. Once eligibility is confirmed, enrollment will be offered. Once enrolled, all groups will undergo comprehensive speech, language, and quality-of-life assessments at baseline and every 9 months thereafter at each site. Assessments will include measures of language, speech, vocabulary, hearing-related quality of life, parental self-efficacy, and early intervention benefit. The investigators will additionally measure therapy utilization and baseline demographic and clinical characteristics.
Children will be allocated to one of the following three study arms: 1) Low-UC (low-income children, randomized to receiving Usual Care); 2) Low-TT (low-income children, randomized to receive Usual Care plus Access to Supplemental Teletherapy), and; 3) High-UC (higher-income children, receiving Usual Care). Low-TT group will receive an 18-month course of teletherapy at their home.
The overall goal of this study is to learn whether improving access to teletherapy for children who are D/HH can reduce disparities in language outcomes. Ongoing engagement with Parent and Stakeholder advisors will occur throughout the study to ensure patient-centeredness and dissemination potential.
Specific Aim 1:Primary Analysis I
Demographic and other baseline data including family characteristics data will be listed and summarized descriptively by the treatment arm. Categorical data will be presented as frequencies and percentages. For continuous data, mean, standard deviation, median, interquartile range, minimum, and maximum will be presented. The Full Analysis Set (FAS) comprises all children to whom trial treatment has been assigned by randomization. According to the intent-to-treat principle, analysis will be completed based on the treatment arm and strata to which children are assigned through the randomization procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 27 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-27 months;
- •Hearing loss, as determined by auditory brainstem response (ABR) or behavioral audiometry (average of pure-tone air-conduction hearing thresholds (0.5-4 kHz; PTA) calculated from at least 2 frequencies from ABR (dB eHL) or behavioral audiometry (dB HL)):
- •bilateral sensorineural, mixed, or permanent conductive hearing loss with better-ear PTA > 20 dB.
- •single-sided deafness (unilateral SNHL with PTA > 70 dB);
- •unilateral complete aural atresia; or
- •bilateral auditory-neuropathy spectrum disorder, as determined by ABR.
- •Primary home language is English or Spanish, determined by electronic medical record or direct parent report.
- •For children with PTA > 20 dB, either:
- •Currently fit with hearing aid or using a cochlear implant; OR
- •Date identified for hearing-aid fitting or cochlear-implant activation within 3 months of enrollment.
排除标准
- •Family does NOT have the intention to pursue listening and spoken language for their child, based on parent report;
- •Moderate to severe global developmental delay, as determined by managing audiologist and/or otolaryngologist, based on:
- •ICD-10 diagnosis code or chart review of medical progress notes indicating global developmental delay;
- •presence of syndrome known to be associated with this delay (such as Trisomy 21, 22q11 syndrome, or CHARGE syndrome); OR
- •parent report.
- •Speech-language teletherapy received through a clinical provider outside of this study at the time of enrollment, based on parent report.
- •No prognosis for access to sound as determined by managing audiologist and/or otolaryngologist. All children with bilateral severe-to-profound SNHL must have imaging to confirm this criterion prior to enrollment in the study. Children will be excluded if they have bilateral severe-to-profound sensorineural hearing loss and either:
- •Contraindication to cochlear implantation, OR
- •Temporal bone abnormalities that lead to great concern for poor cochlear-implant outcomes, including common cavity and/or cochlear nerve deficiency on imaging.
研究组 & 干预措施
Usual Care (High-Income)
This group will receive comprehensive assessments every 9 months for the 18-month period of enrollment, for a total of 3 assessments. They will not be randomized to receive supplemental teletherapy (intervention) and usual care.
Usual Care (Low-Income)
This group includes the low-income families who satisfy the criteria to receive supplemental speech-language teletherapy but are not randomized to receive the intervention after allocation. Like the "Usual Care (High-Income) arm, they will only receive comprehensive assessments every 9 months for the 18-month period of enrollment, for a total of 3 assessments and usual care.
Usual Care + Teletherapy (Low-Income)
This group includes the low-income families who satisfy the criteria to receive supplemental speech-language teletherapy and are randomized to receive the intervention. They will receive both 3x comprehensive assessments every 9 months AND access to supplemental speech-language teletherapy for the 18-month study period.
干预措施: Speech-Language Teletherapy (Other)
结局指标
主要结局
PLS-5 Auditory Comprehension (AC) Standard Score - 18 month
时间窗: 18 months
The PLS-5 is a standard developmental language assessment that measures communication skills in children ages birth to 7 years. Score to report: standard score.
次要结局
- PLS-5 Auditory Comprehension (AC) Standard Score - 18 month change(18 month, change from baseline)
- PLS-5 Expressive Communication (EC) Standard Score - 18 month(18 month)
- PLS-5 Total Language (TL) Standard Score - 9 month(9 month)
- PLS-5 Total Language (TL) Standard Score - 9 month change(9 month, change from baseline)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Receptive(18 month, change from baseline)
- Parent Evaluation of Aural/Oral Performance of Children (PEACH) - 9 month(9 month)
- PLS-5 Auditory Comprehension (AC) Standard Score - 9 month(9 month)
- PLS-5 Expressive Communication (EC) Standard Score - 9 month(9 month)
- PLS-5 Expressive Communication (EC) Standard Score - 9 month change(9 month, change from baseline)
- PLS-5 Expressive Communication (EC) Standard Score - 18 month change(18 month, change from baseline)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Expressive(18 month, change from baseline)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Language Ability(18 month, change from baseline)
- The Goldman-Fristoe Test of Articulation-Third Edition (GFTA-3) - Sounds-in-words(18 month, change from baseline)
- PLS-5 Auditory Comprehension (AC) Standard Score - 9 month change(9 month, change from baseline)
- PLS-5 Total Language (TL) Standard Score - 18 month change(18 month, change from baseline)
- LittlEars Auditory Questionnaire (LEAQ) - 9 month(9 month)
- LittlEars Auditory Questionnaire (LEAQ) - 18 month(18 month)
- Hearing-Related Infant/Toddler and Parent Quality of Life (HIP-QL) - 18 month change(18 month, change from baseline)
- Scale of Parental Self-Efficacy (SPISE) - 18 month(18 month)
- PLS-5 Total Language (TL) Standard Score - 18 month(18 month)
- Scale of Parental Self-Efficacy (SPISE) - 18 month change(18 month, change from baseline)
- Family Outcomes Survey (FOS) - 18 month(18 month)
- The Goldman-Fristoe Test of Articulation-Third Edition (GFTA-3) - Sounds-in-sentences(18 month, change from baseline)
- Parent Evaluation of Aural/Oral Performance of Children (PEACH) - 18 month(18 month)
- Parent Evaluation of Aural/Oral Performance of Children (PEACH) - 9 month change(9 month, change from baseline)
- Parent Evaluation of Aural/Oral Performance of Children (PEACH) - 18 month change(18 month, change from baseline)
- MacArthur Bates Communicative Development Index (MBCDI)(18 month, change from baseline)
- Hearing-Related Infant/Toddler and Parent Quality of Life (HIP-QL) - 9 month(9 month)
- Hearing-Related Infant/Toddler and Parent Quality of Life (HIP-QL) - 9 month change(9 month, change from baseline)
- Scale of Parental Self-Efficacy (SPISE) - 9 month(9 month)
- Family Outcomes Survey (FOS) - 18 month change(18 month, change from baseline)
- Hearing-Related Infant/Toddler and Parent Quality of Life (HIP-QL) - 18 month(18 month)
- Family Outcomes Survey (FOS) - 9 month(9 month)
- Scale of Parental Self-Efficacy (SPISE) - 9 month change(9 month, change from baseline)
- Family Outcomes Survey (FOS) - 9 month change(9 month, change from baseline)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Receptive(9 month)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Receptive(18 month)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Receptive(9 month, change from baseline)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Expressive(9 month)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Expressive(18 month)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Expressive(9 month, change from baseline)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Language Ability(9 month)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Language Ability(18 month)
- Receptive Expressive Emergent Language Test - 4th edition (REEL-4) - Language Ability(9 month, change from baseline)
- The Goldman-Fristoe Test of Articulation-Third Edition (GFTA-3) - Sounds-in-words(9 month)
- The Goldman-Fristoe Test of Articulation-Third Edition (GFTA-3) - Sounds-in-words(18 month)
- The Goldman-Fristoe Test of Articulation-Third Edition (GFTA-3) - Sounds-in-words(9 month, change from baseline)
- The Goldman-Fristoe Test of Articulation-Third Edition (GFTA-3) - Sounds-in-sentences(9 month)
- The Goldman-Fristoe Test of Articulation-Third Edition (GFTA-3) - Sounds-in-sentences(18 month)
- The Goldman-Fristoe Test of Articulation-Third Edition (GFTA-3) - Sounds-in-sentences(9 month, change from baseline)
- MacArthur Bates Communicative Development Index (MBCDI)(9 month)
- MacArthur Bates Communicative Development Index (MBCDI)(18 month)
- MacArthur Bates Communicative Development Index (MBCDI)(9 month, change from baseline)