Developmental Language Disorder and Language ImpairmentNCT05099328
Recasting or Book Reading by Parents or Clinicians
A study testing Recast Therapy and Syntax Stories in people with Developmental Language Disorder and Language Impairment, run by University of Delaware at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Developmental Language Disorder and Language Impairment
- What is being tested?
- Recast Therapy and Syntax Stories
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2021to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 16Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
College Park, Maryland, 20742
University of Delaware
Newark, Delaware, 19711
About this study
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
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.
- Being tested
- Recast Therapy, Syntax Stories
- Keywords
- Recasting, Book Reading, Parent Coaching, Syntax Stories, Theoretical Domains Framework, Complex Syntax, Expressive language, Language Intervention
- Medical subject headings
- Language Development Disorders, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recast TherapyBehavioural
Also called Focused Stimulation
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.
Syntax StoriesBehavioural
Also called Priming, Book Reading
Syntax stories are specially constructed stories read verbatim designed to teach a syntax target.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Recast Therapy |
| 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. Receives: Behavioral: Syntax Stories |
| 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. Receives: Behavioral: Recast Therapy |
| 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) Receives: Behavioral: Syntax Stories |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 week prior to the start of therapy; 2 week post therapy
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.
Measured: 2 week prior to the start of therapy, 2 week post therapy
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.
Measured: During 10 week treatment period
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.
Measured: within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
Secondary outcomes (6)
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.
Measured: 2 week prior to the start of therapy, 2 week post therapy
Palatability of treatment
Likert ratings of how much therapy is enjoyed
Measured: During 10 week treatment period, immediately after each treatment session
Effortfulness of treatment
Likert ratings of how effortful therapy is to deliver.
Measured: During 10 week treatment period, immediately after each treatment session
self-efficacy of treatment provider
Likert ratings of how efficacious the provider perceived the activities to be
Measured: During 10 week treatment period, immediately after each treatment session
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.
Measured: In the first 1.5 weeks of the treatment period
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.
Measured: within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start28 Sep 2021
- Primary completion13 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language Disorder and Language ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Maryland, College Park
- Responsible party
- Principal investigator, Amanda J. Owen Van Horne, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099328
- Sponsor's protocol ID
- 307878
- Other IDs
- R01DC018276
- Status last verified
- May 2026
- First submitted
- 5 Oct 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05099328
- Acronym / sponsor ID
- 307878
- Keywords
- Recasting, Book Reading, Parent Coaching, Syntax Stories, Theoretical Domains Framework, Complex Syntax, Expressive language, Language Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Maryland, College Park
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Recast Therapy Provided By Clinician | Experimental | Behavioral: Recast TherapyChildren 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). |
| Illustrated Syntax Stories Provided by Clinician | Experimental | Behavioral: Syntax StoriesChildren 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. |
| Recast Therapy Provided by a Caregiver | Experimental | Behavioral: Recast TherapyCaregivers 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. |
| Illustrated Syntax Stories Provided by a Caregiver | Experimental | Behavioral: Syntax StoriesCaregivers 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) |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recast TherapyAlso: Focused StimulationRecast 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. | Behavioural | Recast Therapy Provided By Clinician, Recast Therapy Provided by a Caregiver |
| Syntax StoriesAlso: Priming, Book ReadingSyntax stories are specially constructed stories read verbatim designed to teach a syntax target. | Behavioural | Illustrated Syntax Stories Provided by Clinician, Illustrated Syntax Stories Provided by a Caregiver |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
Change in Comprehension probes (Pointing)
Time frame: 2 week prior to the start of therapy, 2 week post therapy
Palatability of treatment
Time frame: During 10 week treatment period, immediately after each treatment session
Effortfulness of treatment
Time frame: During 10 week treatment period, immediately after each treatment session
self-efficacy of treatment provider
Time frame: During 10 week treatment period, immediately after each treatment session
Caregiver grammar knowledge
Time frame: In the first 1.5 weeks of the treatment period
Theoretical Domains Framework (TDF) Questionnaire
Time frame: within 2 weeks post therapy ( ~12- 14 week mark in study timeline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: 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: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recast Therapy and Syntax Stories in people with Developmental Language Disorder and Language Impairment, run by University of Delaware at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Accuracy on Elicited Production Probes (time frame: 2 week prior to the start of therapy; 2 week post therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.