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Recasting or Book Reading by Parents or Clinicians

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ClinicalTrials.gov Identifier: NCT05099328
Recruitment Status : Recruiting
First Posted : October 29, 2021
Last Update Posted : October 29, 2021
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Maryland, College Park
Information provided by (Responsible Party):
Amanda J. Owen Van Horne, University of Delaware

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Developmental Language Disorder and Language Impairment Behavioral: Recast Therapy Behavioral: Syntax Stories Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children are stratified based on treatment site. Then they are randomly assigned to receive treatment for 1 of 2 targets, using 1 of 4 methods of intervention. Each child is randomly assigned to parent or clinician delivered intervention using books or recast therapy (2x2 design). Then assignment to treatment targets is assigned so that it is evenly distributed within each condition.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 28, 2021
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025


Arm Intervention/treatment
Experimental: Recast Therapy Provided By Clinician
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).
Behavioral: Recast Therapy
Recast therapy is when a interventionist uses the child's own productions as a platform for restating or recasting the child's speech with corrections or alterations to focus on a particular syntax target.
Other Name: Focused Stimulation

Experimental: Illustrated Syntax Stories Provided by Clinician
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.
Behavioral: Syntax Stories
Syntax stories are specially constructed stories read verbatim designed to teach a syntax target.
Other Names:
  • Priming
  • Book Reading

Experimental: Recast Therapy Provided by a Caregiver
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.
Behavioral: Recast Therapy
Recast therapy is when a interventionist uses the child's own productions as a platform for restating or recasting the child's speech with corrections or alterations to focus on a particular syntax target.
Other Name: Focused Stimulation

Experimental: Illustrated Syntax Stories Provided by a Caregiver
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)
Behavioral: Syntax Stories
Syntax stories are specially constructed stories read verbatim designed to teach a syntax target.
Other Names:
  • Priming
  • Book Reading




Primary Outcome Measures :
  1. Change in Accuracy on Elicited Production Probes [ Time Frame: 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.

  2. Change in Comprehension probes (Proportion Looking) [ Time Frame: 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.

  3. Estimated Dose Delivered [ Time Frame: 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.

  4. Semi-structured interviews [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Comprehension probes (Pointing) [ Time Frame: 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. Points to the correct picture after the conclusion of eye gaze collection will be the dependent variable.

  2. Palatability of treatment [ Time Frame: During 10 week treatment period, immediately after each treatment session ]
    Likert ratings of how much therapy is enjoyed

  3. Effortfulness of treatment [ Time Frame: During 10 week treatment period, immediately after each treatment session ]
    Likert ratings of how effortful therapy is to deliver.

  4. self-efficacy of treatment provider [ Time Frame: During 10 week treatment period, immediately after each treatment session ]
    Likert ratings of how efficacious the provider perceived the activities to be

  5. Caregiver grammar knowledge [ Time Frame: In the first 1.5 weeks of the treatment period ]
    Written grammar quiz adapted from Brimo (in press). This questionnaire was previously validated for pre-service SLPs, early childhood educators, and practicing SLPs. The first two sections (implicit knowledge) have been used by Brimo. The last two sections (labeling) have been used in our lab to assess the knowledge of graduate clinicians.

  6. Theoretical Domains Framework (TDF) Questionnaire [ Time Frame: within 2 weeks post therapy ( ~12- 14 week mark in study timeline) ]
    Questionnaire aligned with Theoretical Domains Framework constructs that examines the caregiver's comfort and understanding and motivation for participation in therapy. This questionnaire was previously validated for providers of Physical Therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 40% 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

Caregiver

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05099328


Contacts
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Contact: Amanda O Van Horne, PhD CCC-SLP 3194710036 ajovh@udel.edu
Contact: Samantha Weatherford, MS CCC-SLP 302-831-7121 slwslp@udel.edu

Locations
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United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States, 19711
Contact: Amanda J Owen Van Horne, PhD    302-831-7121    ajovh@udel.edu   
Contact: Samantha Weatherford, MA    302-831-7121    slwslp@udel.edu   
Sub-Investigator: Giovana Morini, PhD         
United States, Maryland
University of Maryland Recruiting
College Park, Maryland, United States, 20742
Contact: Yi Ting Huang, PhD    301-405-4227    ythuang1@umd.edu   
Contact: Jan Edwards, PhD    301-405-5237    edwards@umd.edu   
Sponsors and Collaborators
University of Delaware
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Maryland, College Park
  Study Documents (Full-Text)

Documents provided by Amanda J. Owen Van Horne, University of Delaware:
Study Protocol  [PDF] October 5, 2021
Informed Consent Form  [PDF] July 7, 2021

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Responsible Party: Amanda J. Owen Van Horne, Associate Professor, University of Delaware
ClinicalTrials.gov Identifier: NCT05099328    
Other Study ID Numbers: 307878
R01DC018276 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2021    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Summary results of the primary outcomes for Aims 1 & 2 (elicited production and eye-gaze) will be uploaded within 12 months of the last data collection point for the final participant.

We will track and provide information about participant flow. At each phase of participation, we will aggregate and report the following information:

  1. non-qualifiers: available screening information and reason for not continuing;
  2. qualifying participants who continue in the study: screening & pretest information, by treatment group;
  3. participants who complete the study: post-test scores, by treatment group;
  4. participants who drop out: reasons given for dropout, along with any adverse events;

It is not possible to fully de-identify the interviews utilized in the mixed methods study (Aim 3). Thus, these data will not be shared. Additional data at the individual participant level may be sharable upon request and IRB approval for particular access.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: 1 year after final data collection is complete
Access Criteria: IRB approval for access to data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amanda J. Owen Van Horne, University of Delaware:
Recasting
Book Reading
Parent Coaching
Syntax Stories
Theoretical Domains Framework
Complex Syntax
Expressive language
Language Intervention
Additional relevant MeSH terms:
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Language Disorders
Language Development Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases