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Evaluation of an Explicit Approach
NCT04902508 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- BEHAVIORAL Implicit-only
- BEHAVIORAL Explicit-added
Study Locations (1)
Minnesota
- University of Minnesota — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04902508
The ClinicalTrials.gov registry entry for NCT04902508 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 919 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Developmental Language Disorder appearing as the primary indexed condition, and to 2 interventions — of which Implicit-only is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04902508 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04902508 about?
NCT04902508 is a clinical study titled "Evaluation of an Explicit Approach". 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 ...
What is the current status of trial NCT04902508?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 111 participants. The study started on 2022-02-15. Estimated completion is 2027-07-31.
What conditions does trial NCT04902508 study?
This clinical trial studies the following conditions: Developmental Language Disorder, Explicit Intervention, Grammatical Language. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04902508?
The interventions under investigation include: Implicit-only (BEHAVIORAL), Explicit-added (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04902508?
This trial is sponsored by University of Minnesota, which has 919 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04902508 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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