ClinicalTrials.gg
CompletedNCT05099328Updated May 12, 2026

Recasting or Book Reading by Parents or Clinicians

An interventional study of Recast Therapy and Syntax Stories in Developmental Language Disorder and Language Impairment, sponsored by University of Delaware. Completed at 2 sites in United States. Open to participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by University of Delaware · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
137
Allocation
Randomized
Ages
4 Years to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Developmental Language Disorder and Language Impairment

Keywords

  • Recasting
  • Book Reading
  • Parent Coaching
  • Syntax Stories
  • Theoretical Domains Framework
  • Complex Syntax
  • Expressive language
  • Language Intervention
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's enrollment of 137 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
137 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • BehavioralRecast 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.

    Also known as: Focused Stimulation

  • BehavioralSyntax Stories

    Syntax stories are specially constructed stories read verbatim designed to teach a syntax target.

    Also known as: Priming, Book Reading

06

What researchers measure

Primary outcomes

  1. Change in Accuracy on Elicited Production Probes

    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.

    Time frame: 2 week prior to the start of therapy; 2 week post therapy

  2. Change in Comprehension probes (Proportion Looking)

    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.

    Time frame: 2 week prior to the start of therapy, 2 week post therapy

  3. Estimated Dose Delivered

    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.

    Time frame: During 10 week treatment period

  4. Semi-structured interviews

    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.

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

Secondary outcomes

  1. Change in Comprehension probes (Pointing)

    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.

    Time frame: 2 week prior to the start of therapy, 2 week post therapy

  2. Palatability of treatment

    Likert ratings of how much therapy is enjoyed

    Time frame: During 10 week treatment period, immediately after each treatment session

  3. Effortfulness of treatment

    Likert ratings of how effortful therapy is to deliver.

    Time frame: During 10 week treatment period, immediately after each treatment session

  4. self-efficacy of treatment provider

    Likert ratings of how efficacious the provider perceived the activities to be

    Time frame: During 10 week treatment period, immediately after each treatment session

  5. Caregiver grammar knowledge

    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.

    Time frame: In the first 1.5 weeks of the treatment period

  6. Theoretical Domains Framework (TDF) Questionnaire

    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.

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

07

Study locations

2 sites
  • University of Delaware
    Newark, Delaware 19711, United States
  • University of Maryland
    College Park, Maryland 20742, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: 1 year after final data collection is complete

Access criteria: IRB approval for access to data

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Apr 2026, 54 months.

Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's 54 months is above that.

Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2021
First posted
Oct 29, 2021
StartActual
Sep 28, 2021
Primary completionActual
Apr 13, 2026
CompletionActual
Apr 20, 2026
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05099328
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD), University of Maryland, College Park
Responsible party
Amanda J. Owen Van Horne (Associate Professor, University of Delaware) — Principal investigator
First posted
Oct 29, 2021
Start date
Sep 28, 2021
Primary completion
Apr 13, 2026
Completion
Apr 20, 2026
Last update
May 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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