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临床试验/NCT05900180
NCT05900180已完成不适用

Pediatric Speech Therapy Session Frequency and Speech Outcomes

Connecticut Children's Medical Center2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Change in Receptive vocabulary skills

研究概览

简要总结

Examination of frequency of therapy and effect on clinical outcomes.

详细描述

The goal of this clinical trial is to compare speech therapy outcomes in children ages 18 months to 16 years who participate in weekly speech therapy with home programming versus every-other week speech therapy with home programming in outpatient speech therapy. The main question it aims to answer is: Does a change in how often speech therapy sessions are delivered show an increased benefit in language and articulation standardized test scores? Participants will be randomly assigned to either (1) weekly or (2) every-other-week speech therapy for a total of 8 sessions. Researchers will compare these two groups to see if there are differences in speech outcomes.

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
None

入排标准

年龄范围
18 Months 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Medical order for speech therapy
  • Patients eligible for speech therapy at Connecticut Children's (qualify for receptive, expressive language and/or articulation therapy)
  • Diagnosis of communication disorder.ICD-10 codes will be utilized pertaining to expressive, receptive language and articulation disorders (ICD-10 code specific to patient: F80.0, F80.1, F80.2, F80.4, F80.9, R47.89, R41.841)
  • Patient recommended for individual (i.e. not group) treatment
  • 18 months to 16 years of age
  • Completed 1 plan of care (POC) with a duration of 8 sessions
  • Attended at least 80% of scheduled visits during their plan of care period (still completing 8 sessions of therapy, may have extended time to completion).
  • Services for a full 8-session plan of care.

排除标准

  • - Seeking speech therapy care for treatment of disorders related to diagnosis of voice, feeding, fluency, and/or cognition
  • Patient unable to complete standardized tests (EOWPVT-4, ROWPVT-4, GFTA-3, REEL-4)
  • Patients in group speech therapy
  • Patients younger than 18 months or older than 16 years of age
  • Not willing to complete a full POC (8 sessions)
  • Unable/unwilling to attend 80% of scheduled visits

研究组 & 干预措施

Every-other-week therapy with home programming

Active Comparator

Receipt of standard speech therapy care (every-other-week) for 8.0 sessions

干预措施: Speech Therapy (Behavioral)

Weekly therapy with home programming

Experimental

Receipt of speech therapy care (every week) for 8.0 sessions

干预措施: Speech Therapy (Behavioral)

结局指标

主要结局

Change in Receptive vocabulary skills

时间窗: Baseline, immediately after treatment (up to 4 months)

Scores on the following standardized measure: Receptive One Word Picture Vocabulary Test- Fourth Edition (ROVPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding vocabulary.

Change in Receptive and expressive early language skills

时间窗: Baseline, immediately after treatment (up to 4 months)

Scores on the following standardized measures: Receptive-Expressive Emergent Language Scale- Fourth Edition (REEL-4); Average Standard Score range is from 90-109; an increase in standard score indicates improvement in language ability score.

Change in Articulation and intelligibility

时间窗: Baseline, immediately after treatment (up to 4 months)

Scores on the following standardized measures: Goldman Fristoe Test of Articulation- Third Edition (GFTA-3) ; Average Standard Score range is from 86-114; an increase in standard score indicates improvement in intelligibility.

Change in Expressive vocabulary skills

时间窗: Baseline, immediately after treatment (up to 4 months)

Scores on the following standardized measure: Expressive One Word Picture Vocabulary Test- Fourth Edition (EOWPVT-4); Average Standard Score range is from 85-115; an increase in standard score indicates improvement in understanding or labeling vocabulary.

次要结局

  • Home Exercise Plan (HEP) provision(up to 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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