Language Disorders in ChildrenLK!2NCT05133479
Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties
A study testing Let's Know! small-group or TierL 2 Intervention in people with Language Disorders in Children, run by MGH Institute of Health Professions at 2 sites in United States.
Trial summary
In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, 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… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Language Disorders in Children
- What is being tested?
- Let's Know! small-group or TierL 2 Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parental consent to participate in the research;
- Enrollment in Grade 1;
- Scores below the 30th percentile on the OWL Language Screener
- Basic English proficiency as reported by parents/teachers
Who cannot join
- Unable to speak or understand English at a basic level, as reported by parents/teachers;
- Profound disability that severely impairs classroom participation, as reported by teachers;
- Serious behavior issue that severely impairs classroom participation, as reported by teachers.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MGH Institute of Health Professions
Boston, Massachusetts, 02192
The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: Translating Research Into School-based Practice Via Small-group, Language-focused Comprehension Intervention
In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, 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 (Specific Aims 1 and 2). The investigators will also explore whether intervention effects are moderated by dosage, initial language skill, developmental language disorder (DLD) status, word reading skill, nonverbal IQ, and family socioeconomic status (Specific Aim 3).
Children who have low language skills and are thus at risk for reading comprehension difficulties will participate in the study. Children will be randomly assigned to receive Let's Know! in small groups at their respective schools or to a business-as-usual control condition. The investigators will measure children's language and comprehension skills at the beginning and end of Grade 1 as well as in Grade 2 and Grade 3. The investigators hypothesize that children who experience Let's Know! will end Grade 1 with higher language skills than children in the control condition and that this will translate into better listening and reading comprehension skills as these children matriculate through elementary school.
Read the detailed description
Parents of children enrolled in Grade 1 at partnering schools will receive consent materials and those who provide consent will complete a brief background/demographic survey about their child. For children whose parents provide informed consent, research staff will (a) ask their educator to confirm basic English proficiency and lack of profound disabilities or behavior issues that severely impair classroom functioning, (b) seek the child's assent to project activities, and (c) administer a language screener in a quiet location at their respective school, either in a small group of other consented children or one-on-one. In order to qualify as eligible for the intervention phase of the study, consented children must: (1) be enrolled in Grade 1 (per educator or parent report) (2) score at or below the empirically derived cut-score on the OWL screener (obtained via direct testing), (3) exhibit at least basic skills in speaking and understanding English (per educator report), (4) not exhibit behavioral difficulties sufficiently severe to prevent participation in the intervention (per educator report), (5) not have a severe disability that would prevent participation in the intervention (per educator report), (6) assent to study activities. Children who meet all eligibility criteria, including scoring below our cutoff on the language screener, will be categorized as potentially eligible for enrollment in the intervention phase of the study. In order to enroll children within a particular school, the investigators must identify a minimum of 6 eligible participants in that school. The investigators will cap the child participants per school at a maximum of 20 in cohort 1 and 10 in cohorts 2 \& 3 to allow for later analysis of nested data (children nested within schools; the investigators need 40 schools for appropriate statistical power). Children who are identified as potentially eligible but who attend schools with fewer than 6 total eligible participants, or who consent to the study but have not yet been screened by the time the investigators identify 20 eligible participants in cohort 1 and 10 in cohorts 2 \& 3 will be excluded from further participation. In schools in which the investigators have more than the allotted potentially eligible children, the investigators will randomly select the cohort-specific number to enroll in the intervention phase of the study. Children enrolled in the intervention phase of the study will be randomly assigned to receive the Let's Know! intervention or to a business-as-usual control condition. Random assignment will be conducted by Dr. Flemming at KUMC, who will be uninvolved in recruitment, screening, and pretest activities. Prior to intervention start, all enrolled children will complete pretest assessments to measure the lower-level and higher-level language skills targeted by the Let's Know! intervention, comprehension skills, and other abilities (i.e., covariates and moderators for addressing Aim 3). All direct child assessments are listed in Table 1 above. All child direct assessments (screening, pretest, curriculum-aligned measures, posttest, follow-up) will be administered by trained research staff in quiet locations at children's respective schools; alternative arrangements to conduct assessments in the PIs' research laboratories or community locations (e.g., public library) will be made as necessary (e.g., if a child moves into a new, non-partnering school). All but the language screener and Gates-MacGinitie Tests of Reading will be administered individually, with the two exceptions administered to small groups or 1:1, dependent on scheduling. Screening and assessment sessions may be audio or video recorded to allow for accurate scoring and analysis. Following pretest assessments and assignment to conditions, research staff will provide the Let's Know! intervention to small groups of 3 to 5 children allocated to the intervention condition at their respective schools. The Let's Know! intervention provides instruction in the domains of text structure, integration, word knowledge, and grammar; as such, it targets key lower-level (vocabulary) and higher-level (e.g., story grammar, comprehension monitoring, inferencing) language skills to support listening and reading comprehension. The intervention features manualized, soft-scripted lessons that will be provided in small groups of 3-5 children 4 times a week for 25-30 minutes. The lessons are organized into four instructional units that are delivered over 22 weeks. All four instructional units emphasize repeated readings and explorations of commercial texts, with two units comprising narrative books and two comprising expository books. All intervention lessons will be videotaped for purposes of monitoring implementation and coding fidelity. If an individual child misses a session, this will be documented and the session will not be made up. If an entire group misses a session (e.g., due to a field trip/school assembly), the interventionist will wait and deliver that lesson during the next scheduled session (e.g., one group may miss Animals 12 due to a Tuesday assembly; the interventionist teaches Animals 12 at the regularly scheduled Wednesday session and proceeds from there). Children in the control condition will participate in study assessments as noted above but will not experience the Let's Know! intervention. They will receive business-as-usual classroom instruction and supports within their schools. That is, the child's family and school will provide instruction and support for children in the control condition as they typically would for any child not enrolled in the study. The investigators will document the interventions received by children in both the intervention and control conditions.
- Conditions
- Language Disorders in Children
- Being tested
- Let's Know! small-group or TierL 2 Intervention
- Keywords
- language skills, reading comprehension, intervention, specific language impairment, dyslexia
- Medical subject headings
- Specific Language Disorder, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Know! small-group or TierL 2 InterventionBehavioural
Also called Let's Know! small-group or Tier 2 Intervention
Let's Know!2 is an 22-week intervention spanning 1 school year. Each week features 4, 20-30 minute lessons targeting lower-level and higher-level language skills. Within units, instructors and children progress through specific types of lessons to meet language-focused learning objectives. LK!2 was adapted from the original Let's Know! curriculum (LARRC, 2016). The adaption from LK! to LK! made lessons appropriate for small groups of Grade 1 students with low language skills. Adaptations focused on (1) simplification of language input, (2) increased scaffolding, (3) attention to distributed practice, (4) materials to support diversity and inclusion, and (5) enhanced interventionist training. LK!2 comprised 76 20-30 min lessons across four units (fiction, animals, earth materials, folktales) as implemented by trained research staff (i.e., interventionists).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive the Let's Know! intervention in small groups as provided by research staff Receives: Behavioral: Let's Know! small-group or TierL 2 Intervention |
| Business-As-Usual | No intervention | Participants continue to receive only their typical classroom instruction (i.e., no small groups) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment unit 1 (fiction) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 1 (fiction) and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
Measured: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
Treatment unit 2 (animals) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 2 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
Measured: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
Treatment unit 3 (earth materials) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 3 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
Measured: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
Treatment unit 4 (folktales) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses change in children's definitional knowledge of the 8 vocabulary words taught in unit 4 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible per CAM.
Measured: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
Change in vocabulary knowledge as assessed by the LARRC Target Word Knowledge
Change in vocabulary knowledge as assessed by the Language and Reading Research Consortium (LARRC) Target Word Knowledge measures which assesses definitional knowledge of a sampling of words taught across the 4 treatment units, in addition to several words not taught in the intervention.
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in breadth of vocabulary as assessed by the Peabody Picture Vocabulary Test 5th Edition (PPVT-5)
Change in the breadth of vocabulary will be assessed by the Peabody Picture Vocabulary Test 5th Edition (PPVT-5), a standardized measure of the number of words that a child should know compared to a nationwide sample of age-matched peers. Children point to one picture out of four that best represents a word spoken by the examiner.
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Treatment unit 1 (fiction) comprehension monitoring as assessed by the LARRC Unit 1 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
The Language and Reading Research Consortium (LARRC) Unit 1 (fiction) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
Measured: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
Treatment unit 2 (animals) comprehension monitoring as assessed by the LARRC Unit 2 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
The Language and Reading Research Consortium (LARRC) Unit 2 (animals) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
Measured: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
Treatment unit 3 (earth materials) comprehension monitoring as assessed by the LARRC Unit 3 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
The Language and Reading Research Consortium (LARRC) Unit 3 (earth materials) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
Measured: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
Treatment unit 4 (folktales) comprehension monitoring as assessed by the LARRC Unit 4 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
The Language and Reading Research Consortium (LARRC) Unit 4 (folktales) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
Measured: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
Change in child's ability to monitoring comprehension, as assessed by the LARRC Comprehension Monitoring Test
Change in comprehension monitoring as assessed by the Language and Reading Research Consortium (LARRC) Comprehension Monitoring Test, which assesses child's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown from the strategies learned across all 4 treatment units.
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Treatment unit 1 (fiction) knowledge of text structures as assessed by the LARRC Unit 1 Text Structure Curriculum-Aligned Measure (CAM)
The Language and Reading Research Consortium (LARRC) Unit 1 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to a story and answer questions about the stories' structure, such as characters, settings, problem, and resolution.
Measured: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
Treatment unit 2 (animals) knowledge of text structures as assessed by the LARRC Unit 2 Text Structure Curriculum-Aligned Measure (CAM)
The Language and Reading Research Consortium (LARRC) Unit 2 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to an expository text passage and answer questions about the passage, such as main idea and important details.
Measured: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
Treatment unit 3 (earth materials) knowledge of text structures as assessed by the LARRC Unit 3 Text Structure Curriculum-Aligned Measure (CAM)
The Language and Reading Research Consortium (LARRC) Unit 3 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to an expository text passage and answer questions about the passage, such as main idea and important details.
Measured: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
Treatment unit 4 (folktales) knowledge of text structures as assessed by the LARRC Unit 1 Text Structure Curriculum-Aligned Measure (CAM)
The Language and Reading Research Consortium (LARRC) Unit 4 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to a story and answer questions about the stories' structure, such as characters, settings, problem, and resolution.
Measured: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
Change in child's ability to use their knowledge to fill in the gaps in short stories, as assessed by the LARRC Inference Task
Change in child's ability to use their knowledge to fill in the gaps in short stories, as assessed by the Language and Reading Research Consortium (LARRC) Inference Task, which assesses child's ability to answer questions about short stories they have heard presented by the examiner.
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in story retelling abilities, as assessed by the CUBED Narrative Retell measure
Change in child's ability to accurately and completely retell a story as assessed by the CUBED Narrative Retell measure. The examiner tells the child a story using pictures and the child retells the story back to the examiner.
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in ability to understand stories, as assessed by the Test of Narrative Language
Change in the child's ability to understand stories, as assessed by the Test of Narrative Language. The examiner tells the child stories and asks the child questions about those stories.
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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 read aloud to them, as assessed by the LARRC Listening Comprehension Measure, which requires a child to listen to two short stories and answer questions about those stories
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Reading Comprehension Measure
Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Listening Comprehension Measure, which requires a child to read two short stories and answer questions about those stories
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in reading comprehension, as assessed by the norm-referenced Gates-McGinitie Reading Test
Change in child's ability to comprehend short passages that the child reads to themselves, as assessed by their ability to answer questions about those passages using the norm-referenced Gates-McGinitie Reading Test
Measured: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (75)Papers the sponsor has linked to this study.
- Other trials for Language Disorders in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Ohio State University, University of Kansas
- Responsible party
- Principal investigator, Tiffany P. Hogan, PhD, CCC-SLP, FASHA, MGH Institute of Health Professions
- Investigators
- Tiffany P Hogan, PhD, Principal investigator, MGH Institute of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133479
- Sponsor's protocol ID
- 2020P002508
- Other IDs
- 1R01DC018823-01
- Acronym
- LK!2
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Adlof SM, Hogan TP. Understanding Dyslexia in the Context of Developmental Language Disorders. Lang Speech Hear Serv Sch. 2018 Oct 24;49(4):762-773. doi: 10.1044/2018_LSHSS-DYSLC-18-0049.
PubMed 30458538Adlof, S. M., Catts, H. W., & Little, T. D. (2006). Should the simple view of reading include a fluency component? Reading and Writing: An Interdisciplinary Journal, 19, 933-958.
Alloway, T. P., & Gathercole, S. E. (2005). The role of sentence recall in reading and language skills of children with learning difficulties. Learning and Individual Differences, 15, 271-282. doi: https://doi.org/10.1016/j.lindif.2005.05.001
Alonzo, C. N., Yeomans-Maldonado, G., Murphy, K. A., Bevens, B., & Language and Reading Research Consortium. (2016). Predicting second grade listening comprehension using prekindergarten measures. Topics in Language Disorders, 36, 312-333.
Baumann, J. F., Seifert-Kessell, N., & Jones, L. A. (1992). Effect of think-aloud instruction on elementary students' comprehension monitoring abilities. Journal of Reading Behavior, 24, 143-172.
Bengtson, E., Bridges, M., Daniels, D., Brandel, J., & Fisher, C. (2015). Improving language and listening skills in pre-kindergarten children during a summer literacy program. Poster session presented at KSHA, October.
Bridges, M.S., Piasta, S., Daniels, D., & Brandel, J. (February, 2016). Small-group intervention to support language and comprehension: Feasibility and Pilot Data. Presented at Pacific Coast Research Conference, San Diego, CA.
Castles A, Rastle K, Nation K. Ending the Reading Wars: Reading Acquisition From Novice to Expert. Psychol Sci Public Interest. 2018 Jun;19(1):5-51. doi: 10.1177/1529100618772271.
PubMed 29890888Catts HW, Nielsen DC, Bridges MS, Liu YS. Early Identification of Reading Comprehension Difficulties. J Learn Disabil. 2016 Sep;49(5):451-65. doi: 10.1177/0022219414556121. Epub 2014 Oct 24.
PubMed 25344060Catts HW, Adlof SM, Ellis Weismer S. Language deficits in poor comprehenders: a case for the simple view of reading. J Speech Lang Hear Res. 2006 Apr;49(2):278-93. doi: 10.1044/1092-4388(2006/023).
PubMed 16671844Chall, J. S. (1967). Learning to read: The great debate. New York: McGraw-Hill.
Chall, J. S., & Jacobs, V. A. (2003). Poor children's fourth-grade slump. American Educator, 27, 14-15.
Ciullo S, Lo YL, Wanzek J, Reed DK. A Synthesis of Research on Informational Text Reading Interventions for Elementary Students With Learning Disabilities. J Learn Disabil. 2016 May-Jun;49(3):257-71. doi: 10.1177/0022219414539566. Epub 2014 Jun 23.
PubMed 24958632Clements, D. H. (2007). Curriculum research: Toward a framework for research-based curricula. Journal for Research in Mathematics Education, 35-70.
Connor CM, Morrison FJ. Individualizing Student Instruction in Reading: Implications for Policy and Practice. Policy Insights Behav Brain Sci. 2016 Mar;3(1):54-61. doi: 10.1177/2372732215624931. Epub 2016 Jan 20.
PubMed 29732399
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Research Into School-based Practice Via Small-group, Language-focused Comprehension Intervention
- ClinicalTrials.gov ID
- NCT05133479
- Acronym / sponsor ID
- LK!2 / 2020P002508
- Conditions
- Language Disorders in Children
- Keywords
- language skills, reading comprehension, intervention, specific language impairment, dyslexia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 241 participants (actual)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Ohio State University, University of Kansas
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, 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 (Specific Aims 1 and 2). The investigators will also explore whether intervention effects are moderated by dosage, initial language skill, developmental language disorder (DLD) status, word reading skill, nonverbal IQ, and family socioeconomic status (Specific Aim 3).
Children who have low language skills and are thus at risk for reading comprehension difficulties will participate in the study. Children will be randomly assigned to receive Let's Know! in small groups at their respective schools or to a business-as-usual control condition. The investigators will measure children's language and comprehension skills at the beginning and end of Grade 1 as well as in Grade 2 and Grade 3. The investigators hypothesize that children who experience Let's Know! will end Grade 1 with higher language skills than children in the control condition and that this will translate into better listening and reading comprehension skills as these children matriculate through elementary school.
Detailed description
Parents of children enrolled in Grade 1 at partnering schools will receive consent materials and those who provide consent will complete a brief background/demographic survey about their child. For children whose parents provide informed consent, research staff will (a) ask their educator to confirm basic English proficiency and lack of profound disabilities or behavior issues that severely impair classroom functioning, (b) seek the child's assent to project activities, and (c) administer a language screener in a quiet location at their respective school, either in a small group of other consented children or one-on-one. In order to qualify as eligible for the intervention phase of the study, consented children must: (1) be enrolled in Grade 1 (per educator or parent report) (2) score at or below the empirically derived cut-score on the OWL screener (obtained via direct testing), (3) exhibit at least basic skills in speaking and understanding English (per educator report), (4) not exhibit behavioral difficulties sufficiently severe to prevent participation in the intervention (per educator report), (5) not have a severe disability that would prevent participation in the intervention (per educator report), (6) assent to study activities. Children who meet all eligibility criteria, including scoring below our cutoff on the language screener, will be categorized as potentially eligible for enrollment in the intervention phase of the study. In order to enroll children within a particular school, the investigators must identify a minimum of 6 eligible participants in that school. The investigators will cap the child participants per school at a maximum of 20 in cohort 1 and 10 in cohorts 2 \& 3 to allow for later analysis of nested data (children nested within schools; the investigators need 40 schools for appropriate statistical power). Children who are identified as potentially eligible but who attend schools with fewer than 6 total eligible participants, or who consent to the study but have not yet been screened by the time the investigators identify 20 eligible participants in cohort 1 and 10 in cohorts 2 \& 3 will be excluded from further participation. In schools in which the investigators have more than the allotted potentially eligible children, the investigators will randomly select the cohort-specific number to enroll in the intervention phase of the study. Children enrolled in the intervention phase of the study will be randomly assigned to receive the Let's Know! intervention or to a business-as-usual control condition. Random assignment will be conducted by Dr. Flemming at KUMC, who will be uninvolved in recruitment, screening, and pretest activities. Prior to intervention start, all enrolled children will complete pretest assessments to measure the lower-level and higher-level language skills targeted by the Let's Know! intervention, comprehension skills, and other abilities (i.e., covariates and moderators for addressing Aim 3). All direct child assessments are listed in Table 1 above. All child direct assessments (screening, pretest, curriculum-aligned measures, posttest, follow-up) will be administered by trained research staff in quiet locations at children's respective schools; alternative arrangements to conduct assessments in the PIs' research laboratories or community locations (e.g., public library) will be made as necessary (e.g., if a child moves into a new, non-partnering school). All but the language screener and Gates-MacGinitie Tests of Reading will be administered individually, with the two exceptions administered to small groups or 1:1, dependent on scheduling. Screening and assessment sessions may be audio or video recorded to allow for accurate scoring and analysis. Following pretest assessments and assignment to conditions, research staff will provide the Let's Know! intervention to small groups of 3 to 5 children allocated to the intervention condition at their respective schools. The Let's Know! intervention provides instruction in the domains of text structure, integration, word knowledge, and grammar; as such, it targets key lower-level (vocabulary) and higher-level (e.g., story grammar, comprehension monitoring, inferencing) language skills to support listening and reading comprehension. The intervention features manualized, soft-scripted lessons that will be provided in small groups of 3-5 children 4 times a week for 25-30 minutes. The lessons are organized into four instructional units that are delivered over 22 weeks. All four instructional units emphasize repeated readings and explorations of commercial texts, with two units comprising narrative books and two comprising expository books. All intervention lessons will be videotaped for purposes of monitoring implementation and coding fidelity. If an individual child misses a session, this will be documented and the session will not be made up. If an entire group misses a session (e.g., due to a field trip/school assembly), the interventionist will wait and deliver that lesson during the next scheduled session (e.g., one group may miss Animals 12 due to a Tuesday assembly; the interventionist teaches Animals 12 at the regularly scheduled Wednesday session and proceeds from there). Children in the control condition will participate in study assessments as noted above but will not experience the Let's Know! intervention. They will receive business-as-usual classroom instruction and supports within their schools. That is, the child's family and school will provide instruction and support for children in the control condition as they typically would for any child not enrolled in the study. The investigators will document the interventions received by children in both the intervention and control conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Let's Know! small-group or TierL 2 InterventionParticipants receive the Let's Know! intervention in small groups as provided by research staff |
| Business-As-Usual | No intervention | –Participants continue to receive only their typical classroom instruction (i.e., no small groups) |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parental consent to participate in the research;
- Enrollment in Grade 1;
- Scores below the 30th percentile on the OWL Language Screener
- Basic English proficiency as reported by parents/teachers
Key exclusion criteria (3 listed)
- Unable to speak or understand English at a basic level, as reported by parents/teachers;
- Profound disability that severely impairs classroom participation, as reported by teachers;
- Serious behavior issue that severely impairs classroom participation, as reported by teachers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let's Know! small-group or TierL 2 InterventionAlso: Let's Know! small-group or Tier 2 InterventionLet's Know!2 is an 22-week intervention spanning 1 school year. Each week features 4, 20-30 minute lessons targeting lower-level and higher-level language skills. Within units, instructors and children progress through specific types of lessons to meet language-focused learning objectives. LK!2 was adapted from the original Let's Know! curriculum (LARRC, 2016). The adaption from LK! to LK! made lessons appropriate for small groups of Grade 1 students with low language skills. Adaptations focused on (1) simplification of language input, (2) increased scaffolding, (3) attention to distributed practice, (4) materials to support diversity and inclusion, and (5) enhanced interventionist training. LK!2 comprised 76 20-30 min lessons across four units (fiction, animals, earth materials, folktales) as implemented by trained research staff (i.e., interventionists). | Behavioural | Intervention |
Primary outcome
Treatment unit 1 (fiction) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Time frame: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 1 (fiction) and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
Treatment unit 2 (animals) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Time frame: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 2 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
Treatment unit 3 (earth materials) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Time frame: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 3 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
Treatment unit 4 (folktales) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Time frame: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses change in children's definitional knowledge of the 8 vocabulary words taught in unit 4 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible per CAM.
Change in vocabulary knowledge as assessed by the LARRC Target Word Knowledge
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in vocabulary knowledge as assessed by the Language and Reading Research Consortium (LARRC) Target Word Knowledge measures which assesses definitional knowledge of a sampling of words taught across the 4 treatment units, in addition to several words not taught in the intervention.
Change in breadth of vocabulary as assessed by the Peabody Picture Vocabulary Test 5th Edition (PPVT-5)
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in the breadth of vocabulary will be assessed by the Peabody Picture Vocabulary Test 5th Edition (PPVT-5), a standardized measure of the number of words that a child should know compared to a nationwide sample of age-matched peers. Children point to one picture out of four that best represents a word spoken by the examiner.
Treatment unit 1 (fiction) comprehension monitoring as assessed by the LARRC Unit 1 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Time frame: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
The Language and Reading Research Consortium (LARRC) Unit 1 (fiction) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
Treatment unit 2 (animals) comprehension monitoring as assessed by the LARRC Unit 2 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Time frame: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
The Language and Reading Research Consortium (LARRC) Unit 2 (animals) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
Treatment unit 3 (earth materials) comprehension monitoring as assessed by the LARRC Unit 3 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Time frame: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
The Language and Reading Research Consortium (LARRC) Unit 3 (earth materials) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
Treatment unit 4 (folktales) comprehension monitoring as assessed by the LARRC Unit 4 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Time frame: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
The Language and Reading Research Consortium (LARRC) Unit 4 (folktales) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
Change in child's ability to monitoring comprehension, as assessed by the LARRC Comprehension Monitoring Test
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in comprehension monitoring as assessed by the Language and Reading Research Consortium (LARRC) Comprehension Monitoring Test, which assesses child's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown from the strategies learned across all 4 treatment units.
Treatment unit 1 (fiction) knowledge of text structures as assessed by the LARRC Unit 1 Text Structure Curriculum-Aligned Measure (CAM)
Time frame: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
The Language and Reading Research Consortium (LARRC) Unit 1 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to a story and answer questions about the stories' structure, such as characters, settings, problem, and resolution.
Treatment unit 2 (animals) knowledge of text structures as assessed by the LARRC Unit 2 Text Structure Curriculum-Aligned Measure (CAM)
Time frame: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
The Language and Reading Research Consortium (LARRC) Unit 2 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to an expository text passage and answer questions about the passage, such as main idea and important details.
Treatment unit 3 (earth materials) knowledge of text structures as assessed by the LARRC Unit 3 Text Structure Curriculum-Aligned Measure (CAM)
Time frame: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
The Language and Reading Research Consortium (LARRC) Unit 3 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to an expository text passage and answer questions about the passage, such as main idea and important details.
Treatment unit 4 (folktales) knowledge of text structures as assessed by the LARRC Unit 1 Text Structure Curriculum-Aligned Measure (CAM)
Time frame: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
The Language and Reading Research Consortium (LARRC) Unit 4 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to a story and answer questions about the stories' structure, such as characters, settings, problem, and resolution.
Change in child's ability to use their knowledge to fill in the gaps in short stories, as assessed by the LARRC Inference Task
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in child's ability to use their knowledge to fill in the gaps in short stories, as assessed by the Language and Reading Research Consortium (LARRC) Inference Task, which assesses child's ability to answer questions about short stories they have heard presented by the examiner.
Change in story retelling abilities, as assessed by the CUBED Narrative Retell measure
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in child's ability to accurately and completely retell a story as assessed by the CUBED Narrative Retell measure. The examiner tells the child a story using pictures and the child retells the story back to the examiner.
Change in ability to understand stories, as assessed by the Test of Narrative Language
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in the child's ability to understand stories, as assessed by the Test of Narrative Language. The examiner tells the child stories and asks the child questions about those stories.
Change in a child's ability to comprehend short passages read aloud to them, as assessed by the LARRC Listening Comprehension Measure
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in a child's ability to comprehend short passages read aloud to them, as assessed by the LARRC Listening Comprehension Measure, which requires a child to listen to two short stories and answer questions about those stories
Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Reading Comprehension Measure
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Listening Comprehension Measure, which requires a child to read two short stories and answer questions about those stories
Change in reading comprehension, as assessed by the norm-referenced Gates-McGinitie Reading Test
Time frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Change in child's ability to comprehend short passages that the child reads to themselves, as assessed by their ability to answer questions about those passages using the norm-referenced Gates-McGinitie Reading Test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 30458538Adlof SM, Hogan TP. Understanding Dyslexia in the Context of Developmental Language Disorders. Lang Speech Hear Serv Sch. 2018 Oct 24;49(4):762-773. doi: 10.1044/2018_LSHSS-DYSLC-18-0049.
- BackgroundAdlof, S. M., Catts, H. W., & Little, T. D. (2006). Should the simple view of reading include a fluency component? Reading and Writing: An Interdisciplinary Journal, 19, 933-958.
- BackgroundAlloway, T. P., & Gathercole, S. E. (2005). The role of sentence recall in reading and language skills of children with learning difficulties. Learning and Individual Differences, 15, 271-282. doi: https://doi.org/10.1016/j.lindif.2005.05.001
- BackgroundAlonzo, C. N., Yeomans-Maldonado, G., Murphy, K. A., Bevens, B., & Language and Reading Research Consortium. (2016). Predicting second grade listening comprehension using prekindergarten measures. Topics in Language Disorders, 36, 312-333.
- BackgroundBaumann, J. F., Seifert-Kessell, N., & Jones, L. A. (1992). Effect of think-aloud instruction on elementary students' comprehension monitoring abilities. Journal of Reading Behavior, 24, 143-172.
- BackgroundBengtson, E., Bridges, M., Daniels, D., Brandel, J., & Fisher, C. (2015). Improving language and listening skills in pre-kindergarten children during a summer literacy program. Poster session presented at KSHA, October.
- BackgroundBridges, M.S., Piasta, S., Daniels, D., & Brandel, J. (February, 2016). Small-group intervention to support language and comprehension: Feasibility and Pilot Data. Presented at Pacific Coast Research Conference, San Diego, CA.
- Background: PubMed 29890888Castles A, Rastle K, Nation K. Ending the Reading Wars: Reading Acquisition From Novice to Expert. Psychol Sci Public Interest. 2018 Jun;19(1):5-51. doi: 10.1177/1529100618772271.
- Background: PubMed 25344060Catts HW, Nielsen DC, Bridges MS, Liu YS. Early Identification of Reading Comprehension Difficulties. J Learn Disabil. 2016 Sep;49(5):451-65. doi: 10.1177/0022219414556121. Epub 2014 Oct 24.
- Background: PubMed 16671844Catts HW, Adlof SM, Ellis Weismer S. Language deficits in poor comprehenders: a case for the simple view of reading. J Speech Lang Hear Res. 2006 Apr;49(2):278-93. doi: 10.1044/1092-4388(2006/023).
- BackgroundChall, J. S. (1967). Learning to read: The great debate. New York: McGraw-Hill.
- BackgroundChall, J. S., & Jacobs, V. A. (2003). Poor children's fourth-grade slump. American Educator, 27, 14-15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany P Hogan, PhD principal investigator
MGH Institute of Health Professions
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Know! small-group or TierL 2 Intervention in people with Language Disorders in Children, run by MGH Institute of Health Professions at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment unit 1 (fiction) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct (time frame: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133479, which also lists 75 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.