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Evaluation of an Explicit Approach

NCT04902508 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-02-05

No results posted yet for this study

Summary

This study is a randomized clinical trial that uses a Sequential Multiple Assignment Randomized Trial (SMART) study design. The study will directly compare the efficacy of an innovative intervention that combines explicit and implicit approaches to a traditional implicit treatment approach to teach true grammatical forms to children with developmental language disorder (DLD). The study will also compare interventions that include sequences of Explicit-added and Implicit-only treatments. Participants will include 5- through 9-year-old children with DLD who present with significant grammatical weaknesses. In Phase 1, 155 participants will be randomized 1:1 to an Explicit-added treatment group or an Implicit-only treatment group. Each participant will complete 32 sessions targeting four unique grammatical forms (8 sessions/form). In Phase 2, "Masters" will be re-randomized to receive no treatment 32 sessions of the same treatment, or 32 sessions of the alternative treatment. "Non-Masters" will be re-randomized to receive 32 additional sessions of the same treatment or 32 sessions of the alternative treatment. Performance will be measured on acquisition, maintenance, and generalization probes obtained immediately,1-, 6-, and 12- months post-intervention. The SMART study design will be used to determine if child factors, including expressive and receptive language abilities, nonverbal IQ, and executive function skills can reliably predict the treatment sequence that optimizes language learning. Study results will help to determine the best sequence approach to ameliorate grammatical weaknesses, one of the core deficits of young children with language impairment.

Conditions

  • Developmental Language Disorder
  • Explicit Intervention
  • Grammatical Language

Interventions

BEHAVIORAL

Implicit-only

Each intervention session will comprise four core activities: sentence imitation, presentation of a model story with production opportunities, and auditory bombardment.

BEHAVIORAL

Explicit-added

Each intervention session will comprise four core activities: sentence imitation, presentation of a model story with production opportunities, and auditory bombardment. Interventionists will also present the rule/pattern guiding the target form.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902508 on ClinicalTrials.gov