NCT05099328

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Sep 2021Aug 2027

Study Start

First participant enrolled

September 28, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2027

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

4.7 years

First QC Date

October 5, 2021

Last Update Submit

July 21, 2025

Conditions

Keywords

RecastingBook ReadingParent CoachingSyntax StoriesTheoretical Domains FrameworkComplex SyntaxExpressive languageLanguage Intervention

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

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

Secondary Outcomes (6)

  • Change in Comprehension probes (Pointing)

    2 week prior to the start of therapy, 2 week post therapy

  • Palatability of treatment

    During 10 week treatment period, immediately after each treatment session

  • Effortfulness of treatment

    During 10 week treatment period, immediately after each treatment session

  • self-efficacy of treatment provider

    During 10 week treatment period, immediately after each treatment session

  • Caregiver grammar knowledge

    In the first 1.5 weeks of the treatment period

  • +1 more secondary outcomes

Study Arms (4)

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).

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.

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.

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)

Behavioral: Syntax Stories

Interventions

Recast TherapyBEHAVIORAL

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
Recast Therapy Provided By ClinicianRecast Therapy Provided by a Caregiver
Syntax StoriesBEHAVIORAL

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

Also known as: Priming, Book Reading
Illustrated Syntax Stories Provided by ClinicianIllustrated Syntax Stories Provided by a Caregiver

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Delaware

Newark, Delaware, 19711, United States

RECRUITING

University of Maryland

College Park, Maryland, 20742, United States

RECRUITING

MeSH Terms

Conditions

Language Development DisordersLanguage Disorders

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Amanda O Van Horne, PhD CCC-SLP

CONTACT

Samantha Weatherford, MS CCC-SLP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 29, 2021

Study Start

September 28, 2021

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

August 28, 2027

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
1 year after final data collection is complete
Access Criteria
IRB approval for access to data

Locations