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Let's Know! Intervention for Childhood Language Disorders (LK!2 Trial)
N/A
Recruiting
Led By Tiffany P Hogan, PhD
Research Sponsored by MGH Institute of Health Professions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after intervention ends
Awards & highlights
LK!2 Trial Summary
This trial will test the efficacy of Let's Know!, a small-group, language focused comprehension intervention, on children's lower- and higher-level language skills and comprehension skills in the short- and long-term.
Who is the study for?
This trial is for Grade 1 children with low language skills, at risk of comprehension difficulties. They must have parental consent, score below a specific language screener threshold, and possess basic English proficiency. Children with profound disabilities or serious behavior issues affecting classroom participation are excluded.Check my eligibility
What is being tested?
The 'Let's Know!2' intervention is being tested to improve language and reading comprehension in young children. This study randomly assigns kids to either the Let's Know! program or regular school activities and tracks their progress from Grade 1 through Grade 3.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 variations in individual experiences based on the child’s engagement and response to the intervention.
LK!2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after intervention ends
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after intervention ends
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in a child's ability to comprehend short passages read aloud to them, as assessed by the LARRC Listening Comprehension Measure
Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Reading Comprehension Measure
Change in ability to understand stories, as assessed by the Test of Narrative Language
+18 moreOther outcome measures
Academic performance will be assessed by the Massachusetts or Ohio State Assessments of Reading
Change in timed word and nonword reading, as assessed by the Test of Word Reading Efficiency - Second Edition
Language comprehension skills, as assessed by the OWL Language Screener
+1 moreLK!2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants receive the Let's Know! intervention in small groups as provided by research staff
Group II: Business-As-UsualActive Control1 Intervention
Participants continue to receive only their typical classroom instruction (i.e., no small groups)
Find a Location
Who is running the clinical trial?
University of KansasOTHER
147 Previous Clinical Trials
325,381 Total Patients Enrolled
Ohio State UniversityOTHER
829 Previous Clinical Trials
505,155 Total Patients Enrolled
MGH Institute of Health ProfessionsLead Sponsor
15 Previous Clinical Trials
3,175 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have scores lower than what is required on the OWL Language Screener.You have a significant behavior problem that makes it hard for you to take part in class, according to what your teachers have said.My disability significantly affects my ability to participate in class.I am in the first grade of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Business-As-Usual
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.
Does this research endeavor seek participants aged forty or older?
"This research is seeking participants aged between 5 and 12 years old."
Answered by AI
Is the current recruitment initiative accepting study participants?
"Affirmative. The data present on clinicaltrials.gov affirms that this medical trial, initially posted in January 2021, is actively recruiting participants. 480 individuals need to be recruited from two separate research centres."
Answered by AI
Am I able to join this research program?
"This study is currently enrolling around 480 young patients aged 5 to 12 who have language impairments."
Answered by AI
To what extent is this experiment being conducted in terms of the number of participants?
"Indeed, the clinical trial is still recruiting according to information found on clinicaltrials.gov. The initial posting was made on January 1st 2021 and last revised November 9th 2022. This investigation requires 480 participants across two sites for completion."
Answered by AI
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