Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties

NCT05133479 | Active Not Recruiting

• 2 other identifiers: 2020P0025081R01DC018823-01
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 2

Brief 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 (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.

Conditions

Language Disorders in Children

Keywords

language skills; reading comprehension; intervention; specific language impairment; dyslexia

Outcome Measures

Primary Outcomes (21)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

Other Outcomes (4)

• Nonverbal intelligence as assessed by the Kaufman Brief Intelligence Test - Second Edition nonverbal intelligence (matrices) subtest

  right before intervention starts

• Change in timed word and nonword reading, as assessed by the Test of Word Reading Efficiency - Second Edition

  right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention

• Language comprehension skills, as assessed by the OWL Language Screener

  right before intervention starts

Study Arms (2)

Intervention

EXPERIMENTAL

Participants receive the Let's Know! intervention in small groups as provided by research staff

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)

Interventions

Let's Know! small-group or TierL 2 Intervention BEHAVIORAL

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).

Also known as: Let's Know! small-group or Tier 2 Intervention

Intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: collaborator
• University of Kansas: collaborator
• MGH Institute of Health Professions: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

MGH Institute of Health Professions

Boston, Massachusetts, 02192, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

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• Torgesen, J. K. (2000). Individual differences in response to early interventions in reading: The lingering problem of treatment resisters. Learning Disabilities Research & Practice, 15(1), 55-64.

  BACKGROUND

• Torgesen, J. K., Wagner, R. K., & Rashotte, C. A. (1999). Test of word reading efficiency. Austin, TX: Pro-Ed.

  BACKGROUND

• Vaughn, S., Linan-Thompson, S., Kouzekanani, K., Pedrotty Bryant, D., Dickson, S., & Blozis, S.A. (2003). Reading instruction grouping for students with reading difficulties. Remedial and Special Education, 24, 301-315.

  BACKGROUND

• Wright, T. S., & Cervetti, G. N. (2017). A systematic review of the research on vocabulary instruction that impacts text comprehension. Reading Research Quarterly, 52, 203-226

  BACKGROUND

• Wright, T. S., & Neuman, S. B. (2013). Vocabulary instruction in commonly used kindergarten core reading curricula. The Elementary School Journal, 113(3), 386-408.

  BACKGROUND

MeSH Terms

Conditions

Specific Language Disorder; Dyslexia

Condition Hierarchy (Ancestors)

Language Development Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Specific Learning Disorder

Study Officials

• Tiffany P Hogan, PhD

  MGH Institute of Health Professions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: November 24, 2021
• Study Start: January 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (2)