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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study participants will include children with language impairment, aged 5 through 9 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Awards & highlights
Study Summary
This trial will compare the efficacy of an innovative intervention combining explicit and implicit approaches to teaching true grammatical forms to children with developmental language disorder (DLD), to a traditional implicit treatment approach.
Who is the study for?
This trial is for English-speaking children aged 5-9 with developmental language disorder (DLD) and grammatical weaknesses. They must be native English speakers, have typical hearing and vision (with correction if needed), and not have conditions like autism or Down syndrome that could explain their language issues.Check my eligibility
What is being tested?
The study compares two treatments for DLD: one that adds explicit grammar teaching to the usual implicit approach, versus an implicit-only method. Kids will get randomized to start with one treatment, then possibly switch based on their progress in learning grammar.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, traditional side effects are not applicable. However, there may be differences in how each child responds to the teaching methods used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has a language impairment and is between 5 and 9 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 64 sessions (or approximately 8 months) and 6-months, and 12-months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Developmental Sentence Scoring (DSS)
Grammatical Language Probe
Mean Length of Utterance - Morphemes (MLU-m)
+1 moreTrial Design
10Treatment groups
Experimental Treatment
Group I: Implicit Non-Master Plus Implicit TreatmentExperimental Treatment1 Intervention
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of implicit treatment.
Group II: Implicit Non-Master Plus Explicit TreatmentExperimental Treatment2 Interventions
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of explicit treatment.
Group III: Implicit Master Plus No Additional TreatmentExperimental Treatment1 Intervention
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Group IV: Implicit Master Plus Implicit TreatmentExperimental Treatment1 Intervention
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of implicit treatment.
Group V: Implicit Master Plus Explicit TreatmentExperimental Treatment2 Interventions
Receives 32 sessions of implicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of explicit treatment.
Group VI: Explicit Non-Master Plus Implicit TreatmentExperimental Treatment2 Interventions
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 sessions of implicit treatment.
Group VII: Explicit Non-Master Plus Explicit TreatmentExperimental Treatment1 Intervention
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Non-Mastery" and receives 32 additional sessions of explicit treatment.
Group VIII: Explicit Master Plus No Additional TreatmentExperimental Treatment1 Intervention
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives no additional treatment.
Group IX: Explicit Master Plus Implicit TreatmentExperimental Treatment2 Interventions
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 sessions of implicit treatment.
Group X: Explicit Master Plus Explicit TreatmentExperimental Treatment1 Intervention
Receives 32 sessions of explicit treatment then assessed. When assessed, demonstrates "Mastery" and receives 32 additional sessions of explicit treatment.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,296 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant delay in thinking and understanding.More than half of what you say during a 20-minute conversation includes the right subject and verb combinations.I speak Mainstream American English.You do not have significant problems with thinking or memory.People with attention deficit/hyperactivity disorder will be included because they often have other health issues.My child has a language impairment and is between 5 and 9 years old.You have normal hearing and vision, or wear corrective lenses if needed.You should not have trouble using certain types of grammar, like using "s" at the end of words, adding "ed" to the end of words, or using "is/are" and "do/does" in sentences.I have been surrounded by English at home since birth.You have unusual hearing or vision, but it can be corrected with glasses or hearing aids if needed.I am aged 5-9 with a language impairment.You have trouble speaking or understanding language.You will not be included if you have other significant conditions that could affect your participation, like autism, Down syndrome, seizures, or hearing problems.You have difficulty saying certain sounds like "s," "z," "t," and "d" at the end of words.Criterion: You speak a dialect of English that is not commonly used in the United States.Can say the sounds "s," "z," "t," and "d" clearly.Less than half of your spoken sentences include a subject and a verb in the right places during a 20-minute conversation test to make sure the treatment is suitable for you.You have trouble using certain types of grammar, like adding -s to verbs or using past tense -ed.
Research Study Groups:
This trial has the following groups:- Group 1: Implicit Master Plus No Additional Treatment
- Group 2: Implicit Master Plus Implicit Treatment
- Group 3: Explicit Non-Master Plus Implicit Treatment
- Group 4: Implicit Non-Master Plus Implicit Treatment
- Group 5: Implicit Non-Master Plus Explicit Treatment
- Group 6: Implicit Master Plus Explicit Treatment
- Group 7: Explicit Non-Master Plus Explicit Treatment
- Group 8: Explicit Master Plus No Additional Treatment
- Group 9: Explicit Master Plus Explicit Treatment
- Group 10: Explicit Master Plus Implicit Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial only for people over the age of 50?
"The age requirement for participants in this trial is 5 years or older but younger than 8 years old."
Answered by AI
Who can sign up to help with this medical research?
"This study is looking for 200 participants aged 5 and 8 who have speech delay. Patients must meet the following criteria: Be able to produce mostly grammatically correct sentences (> 50%) in conversations, No significant cognitive delay, Language impairment, Poor performance on two or more of the following grammatical forms: third person singular -s, regular past tense -ed, auxiliary is/are in statements, auxiliary do/does in questions, Poor pronunciation of final-position phonemes /s/, /z/, /t/, and /d/."
Answered by AI
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