Status:
ACTIVE_NOT_RECRUITING
Evaluation of an Explicit Approach
Lead Sponsor:
University of Minnesota
Conditions:
Developmental Language Disorder
Explicit Intervention
Eligibility:
All Genders
5-9 years
Phase:
NA
Brief 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 t...
Detailed Description
This study is a randomized trial with two phases. Phase 1 is a traditional randomized trial during which eligible and consenting participants will be randomized equally to one of two interventions: Ex...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04902508
Start Date
February 15 2022
End Date
May 31 2026
Last Update
November 14 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455