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ACTIVE NOT RECRUITING

NCT04902508

Evaluation of an Explicit Approach

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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.

Official title: Evaluation of an Explicit Approach to Teach Grammatical Forms to Children With Language Impairment

Key Details

Gender

All

Age Range

5 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2022-02-15

Completion Date

2027-07-31

Last Updated

2026-02-05

Healthy Volunteers

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.

Inclusion Criteria: 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. Exclusion Criteria: 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.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States