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临床试验/NCT05099328
NCT05099328已完成不适用

Recasting and Book Reading Under Ideal (Dose-controlled) and Typical (Dose-variable) Conditions: The Role of Fidelity and Adherence in Production and Comprehension Outcomes for Children With DLD

University of Delaware4 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2021年9月28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
137
试验地点
4
主要终点
Estimated Dose Delivered

研究概览

简要总结

Developmental Language Disorder (DLD) affects approximately seven percent of the population and is characterized by grammatical deficits that cascade into lifelong academic challenges and under-employment. Current treatments for DLD produce good outcomes under ideal, high intensity conditions or when parents have been trained to deliver therapy using intense coaching methods; however, current publicly funded service delivery systems and private-pay reimbursement models do not support treatment being delivered in this ideal fashion for children older than three. This project will examine alternative methods of delivering treatment that may be more feasible under typical conditions and will identify implementation barriers, with the goal of improving long-term outcomes for children with DLD. We hypothesize that feasibility and palatability will influence dose, which will in turn affect the overall language 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
Single (Outcomes Assessor)

盲法说明

The outcomes assessor is unaware of the arm to which the child has been assigned and is also unaware of which of two targets are the treatment target.

入排标准

年龄范围
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child with DLD
  • Age: 4-9 years old
  • Primarily English speaking: as documented by 20% or less exposure to another language, per parent report on the MAPLE
  • Diagnosed with DLD as documented by standard score below 85 on the Diagnostic Evaluation of Language Variation - Norm Referenced (DELV-NR) composite, a dialect neutral assessment (Seymour, Roeper, de Villiers, & De Villiers, 2005).
  • Nonverbal Intelligence Quotient (IQ) within typical range as documented by a t-score at or above 35 on the Developmental Abilities Scale (DAS), matrices similarities subscale, (Elliott, 2007).
  • Hearing within the typical range: Pass screening at 25 dB for 1, 2, 4 kHz; OR scores within the typical range via SoundScouts hearing screening app; OR clear hearing assessment from an audiologist, otolaryngologist, medical doctor, or other professional.
  • No diagnosis of Autism: Cutoff score of 15 on the Social Communication Questionnaire, (Rutter, Bailey, & Lord, 2003)
  • No diagnosis of significant sensory-motor concerns or significant psychiatric disorders per parent report
  • Able to benefit from treatment:
  • Score below 60% correct on experimenter developed elicited production probes of passives and object relative clauses
  • Producing simple transitive sentences (SVO) and mean length of utterance (MLU) of 2.5 on 100 utterance language sample
  • Serves as the primary caregiver for an eligible child (may include grandparents, etc.)
  • Basic literacy skills per self-report
  • Willing to participate in caregiver training and caregiver-based treatments if child is assigned to that condition
  • Willing to participate in questionnaires and structured interviews during post-test

排除标准

  • 未提供

研究组 & 干预措施

Illustrated Syntax Stories Provided by Clinician

Experimental

Children will be listen to books that are specially scripted to promote the use of a particular syntax target. Treatment will be provided 2x/week for 8 weeks for a total of 16 visits (960 exposures), with 2 books read at each visit. 2 additional weeks are allocated for make up visits. Treatment will be provided by a trained, certified, licensed SLP.

干预措施: Syntax Stories (Behavioral)

Recast Therapy Provided by a Caregiver

Experimental

Caregivers will receive two training sessions on how to provide recast therapy and demonstrate their skill at providing recast therapy with support from the clinician. Caregivers will then provide recast therapy at a rate of 1 recast per minute to their children for a minimum of 16 hrs (960 exposures) scheduled at their own convenience.

干预措施: Recast Therapy (Behavioral)

Illustrated Syntax Stories Provided by a Caregiver

Experimental

Caregivers will receive two training sessions on how to provide read illustrated syntax stories to their children and demonstrate their skill at reading these stories with support from the clinician. Caregivers will then read these stories to their children for a minimum of 32 book readings (960 exposures)

干预措施: Syntax Stories (Behavioral)

Recast Therapy Provided By Clinician

Experimental

Children will be exposed to recasts at a rate of 1/minute. Treatment will be provided 2x/week for 8 weeks for a total of 16 visits (960 recasts). 2 additional weeks are allocated for make up visits. Treatment will be provided by a trained, certified, licensed Speech Language Pathologist (SLP).

干预措施: Recast Therapy (Behavioral)

结局指标

主要结局

Estimated Dose Delivered

时间窗: During 10 week treatment period

Adherence (attendance, reported therapy delivery)and treatment fidelity derived from recordings will be combined to estimate the number of exposures/recasts the caregiver provided to the child. This primary measure is important for future studies given the need to understand how well treatment is provided by parents and lab staff for these types of syntactic forms.

Change in Accuracy on Elicited Production Probes

时间窗: 2 week prior to the start of therapy; 2 week post therapy

Children will respond to 20 item elicited production probes that ask the child to produce the treated structures and a control structure. Elicited Production Probes are highly reliable (ICC \>.9), valid measures of children's use of a grammatical form. They have clinical relevance and align with the types of items that occur on standardized tests of language use.

Change in Comprehension probes (Proportion Looking)

时间窗: 2 week prior to the start of therapy, 2 week post therapy

Children will participate in an online looking while listening task with 24 items each for the treated target and a control (untreated) structure. Looks to areas of interest on the screen will be recorded. Proportion of time looking at the target picture will be the dependent variable. Looking patterns provide insight into the online processes associated with language comprehension and thus has the potential to inform future studies. These online measures have become well accepted as valid means of understanding comprehension. As far as we are aware there is limited psychometric data available for this age group, but Farris-Trimble \& McMurray (2013) have shown these types of paradigms to be reliable.

Semi-structured interviews

时间窗: within 2 weeks post therapy ( ~12- 14 week mark in study timeline)

Ethnographic interview examines the caregiver's comfort and understanding and motivation for participation in therapy. Ethnographic interviewing is a valid and reliable technique for qualitative data collection.

次要结局

  • Change in Comprehension probes (Pointing)(2 week prior to the start of therapy, 2 week post therapy)
  • self-efficacy of treatment provider(During 10 week treatment period, immediately after each treatment session)
  • Effortfulness of treatment(During 10 week treatment period, immediately after each treatment session)
  • Caregiver grammar knowledge(In the first 1.5 weeks of the treatment period)
  • Palatability of treatment(During 10 week treatment period, immediately after each treatment session)
  • Theoretical Domains Framework (TDF) Questionnaire(within 2 weeks post therapy ( ~12- 14 week mark in study timeline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amanda J. Owen Van Horne

Associate Professor

University of Delaware

研究点 (4)

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