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Completed

NCT Number: NCT05099328

Recasting or Book Reading by Parents or Clinicians

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.

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware, Newark, Delaware, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recast Therapy

Behavioral

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: Focused Stimulation

Syntax Stories

Behavioral

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

Other names: Priming, Book Reading

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of Maryland, College Park

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2021
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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