Recruiting

DLD

Sponsor:

University of Cincinnati

Code:

NCT05268341

Conditions

Developmental Language Disorder

Eligibility Criteria

Sex: All

Age: 4 - 5

Healthy Volunteers: Accepted

Interventions

My Sentence Builder

Study Details

Brief summary:

Children with developmental language disorders (DLD, aka specific language impairment), a prevalent pediatric disorder, experience hallmark grammar deficits with life-long impacts on educational and occupational outcomes. While effective and early interventions can mitigate the impact of DLD, not enough is known about the neural basis of DLD in young children, yet is needed to inform the design of more individualized interventions. This project uses neuroimaging, along with behavioral methods, with the goal of better understanding the memory-language mechanisms that underlie grammar learning and impairment, while also considering their association to treatment-related changes in preschoolers with DLD.

Conditions

Developmental Language Disorder

Study ID

NCT05268341

Start date

May 24, 2022

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 5

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ages 48-71 months
  • average nonverbal intelligence quotient (IQ)
  • enrolled in participating center
  • typically developing (receptive and expressive language, social, articulation, other)
  • DLD for expressive grammar
  • typical oral motor function
  • typical social/pragmatics skills
  • average hearing thresholds
  • monolingual and native Standard English speakers
  • does not have any uncorrected vision challenges

Exclusion Criteria:

  • receiving co-occurring speech-language or other intervention for communication
  • not MRI safe
  • special education placement of child based on ability or behavior

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

computer assisted intervention targeting expressive grammar for preschoolers with DLD

no intervention: No treatment

business as usual classroom (educational) services

Interventions

My Sentence Builder

computer-assisted treatment program for expressive grammar

Primary outcome measure

  • Functional connectivity data (time 1) from typical and DLD preschoolers [ Time Frame: Time 1 (pre) ]
  • Functional connectivity data DLD preschoolers only to assess changes with treatment [ Time Frame: Pre-to-post (up to 14 weeks), post-to-followup (at 27 to 28 weeks) ]
  • Functional connectivity data for typically developing and DLD preschoolers to assess changes in development [ Time Frame: pre-to-follow-up (up to 28 weeks) ]

Central Contacts and Locations

Central contacts

Karla N Washington, PhD

513-558-8533washink2@ucmail.uc.edu

Jennifer J Vannest, PhD

513-558-8518vannesjr@ucmail.uc.edu

Locations

Empower Learn Create INC

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Sandy Paul

513-961-2825spaul@empowerlearncreate.org

Audrey Wilson

513-961-2825awilson@empowerlearncreate.org

CWFF CHild Development Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Robin Brandy

513-569-5662cwffchilddevelopment@gmail.com

Wesley Education Center for Children and Families

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Carla Butler

513-845-7990crbutler0915@yahoo.com

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Amber Yusko, MA

513-558-1416meadowae@ucmail.uc.edu

Linda Roedig

513-558-8503roedigla@ucmail.uc.edu

More Information

Sponsor

University of Cincinnati

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-05-26.