- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05099328
Recasting or Book Reading by Parents or Clinicians
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Delaware
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Newark, Delaware, United States, 19711
- University of Delaware
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Maryland
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College Park, Maryland, United States, 20742
- University of Maryland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
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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 Names:
|
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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.
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Syntax stories are specially constructed stories read verbatim designed to teach a syntax target.
Other Names:
|
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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.
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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 Names:
|
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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)
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Syntax stories are specially constructed stories read verbatim designed to teach a syntax target.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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2 week prior to the start of therapy; 2 week post therapy
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Change in Comprehension probes (Proportion Looking)
Time Frame: 2 week prior to the start of therapy, 2 week post therapy
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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.
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2 week prior to the start of therapy, 2 week post therapy
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Estimated Dose Delivered
Time Frame: During 10 week treatment period
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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.
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During 10 week treatment period
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Semi-structured interviews
Time Frame: within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
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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.
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within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Comprehension probes (Pointing)
Time Frame: 2 week prior to the start of therapy, 2 week post therapy
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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.
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2 week prior to the start of therapy, 2 week post therapy
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Palatability of treatment
Time Frame: During 10 week treatment period, immediately after each treatment session
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Likert ratings of how much therapy is enjoyed
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During 10 week treatment period, immediately after each treatment session
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Effortfulness of treatment
Time Frame: During 10 week treatment period, immediately after each treatment session
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Likert ratings of how effortful therapy is to deliver.
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During 10 week treatment period, immediately after each treatment session
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self-efficacy of treatment provider
Time Frame: During 10 week treatment period, immediately after each treatment session
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Likert ratings of how efficacious the provider perceived the activities to be
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During 10 week treatment period, immediately after each treatment session
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Caregiver grammar knowledge
Time Frame: In the first 1.5 weeks of the treatment period
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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.
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In the first 1.5 weeks of the treatment period
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Theoretical Domains Framework (TDF) Questionnaire
Time Frame: within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
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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.
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within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 307878
- R01DC018276 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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:
- non-qualifiers: available screening information and reason for not continuing;
- qualifying participants who continue in the study: screening & pretest information, by treatment group;
- participants who complete the study: post-test scores, by treatment group;
- 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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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