Evaluation of an Explicit Approach

Running, not enrolling · Not applicable

Conditions studied: Developmental Language Disorder, Explicit Intervention, Grammatical Language

In brief

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.

Key facts

Study ID: NCT04902508
Run by: University of Minnesota
People needed: 111
Starts: 2022-02-15
Expected to finish: 2027-07-31
Last updated by the study team: 2026-02-05

Who can join

Age: 5 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Study participants will include children with language impairment, aged 5 through 9 years. Participants will not have any indication of other significant conditions to which their impairment may be attributed, such as autism spectrum disorder, Down syndrome, seizure disorder, or hearing impairment. Participants with a diagnosis of attention deficit/hyperactivity disorder will be included due to high rate of co-morbidity (see Redmond, 2016). Additionally, participants will meet the following criteria:
No evidence of significant cognitive delay;
Evidence of language impairment;
Evidence of deficits on expressive grammatical forms: score below 30% accuracy on at least two of the following forms: third person singular -s, regular past tense -ed, auxiliary is/are in statements, auxiliary do/does in questions;
Typical hearing and vision, with correction if necessary;
Native English speaker with English spoken in the home by at least one primary caregiver since birth;
Speaker of Mainstream American English;
Be able to articulate final-position phonemes /s/, /z/, /t/, and /d/; and
Majority of utterances (> 50%) include subject and verb in obligated contexts based on a 20-min conversational language sample to ensure appropriateness of study intervention.

You may not qualify if…

Participants will be excluded if there is no indication of language impairment, and they are not aged 5 through 9 years. Participants will also be excluded if there is indication of other significant conditions to which their impairment may be attributed, such as autism spectrum disorder, Down syndrome, seizure disorder, or hearing impairment. Additionally, participants will be excluded in they meet the following criteria:
Evidence of significant cognitive delay;
No evidence of deficits on expressive grammatical forms: score below 30% accuracy on at least two of the following forms: third person singular -s, regular past tense -ed, auxiliary is/are in statements, auxiliary do/does in questions;
Atypical hearing and vision, with correction if necessary;
Non-native English speaker;
Speaker of Non-mainstream American English;
Unable to articulate final-position phonemes /s/, /z/, /t/, and /d/; and
Non-majority of utterances (< 50%) include subject and verb in obligated contexts based on a 20-min conversational language sample to ensure appropriateness of study intervention.

Where it is running

University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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