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NCT04902508 · ClinicalTrials.gov registry record · NA
Evaluation of an Explicit Approach
A NA study of Developmental Language Disorder and Explicit Intervention, sponsored by University of Minnesota.
- Active
- Registry status
- NA
- Development phase
- 111
- Enrollment target
- 1
- Study location
NCT04902508 is a NA study of Developmental Language Disorder and Explicit Intervention that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 111 participants, below the 176-participant average among 17 other Developmental Language Disorder trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04902508, a NA study of Developmental Language Disorder and Explicit Intervention, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 111 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 17 other Developmental Language Disorder trials with a reported enrollment target (37% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
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.
NCT04902508 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
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.
What interventions are being tested in trial NCT04902508?
The interventions under investigation include: Implicit-only (BEHAVIORAL), Explicit-added (BEHAVIORAL).
Who is sponsoring clinical trial NCT04902508?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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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