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

Language Disorders in Children Clinical Trial

— LK!2  

Official title:

Translating Research Into School-based Practice Via Small-group, Language-focused Comprehension Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133479
• Other study ID #: 2020P002508
• Secondary ID: 1R01DC018823-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: MGH Institute of Health Professions
• Contact: Tiffany P Hogan, PhD
• Phone: 6177241054
• Email: thogan[@]mghihp.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

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 order 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, will be excluded from further participation. In schools in which the investigators have more than 20 potentially eligible children, the investigators will randomly select 20 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Parental consent to participate in the research;
• Enrollment in Grade 1;
• Scores below the OWL Language Screener
• Basic English proficiency as reported by parents/teachers

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Language Disorders
• Language Disorders in Children

Intervention

Behavioral:
• Let's Know! small-group or TierL 2 Intervention
Let's Know! is an 22-week intervention spanning 1 school year. Each week features 4-5, 30 minute lessons targeting lower-level and higher-level language skills. There are 2 narrative and 2 expository units. Within units, instructors and children progress through specific types of lessons to meet language-focused learning objectives. Lesson types include (a) Read to Me, designed to engage children with text and promote discussion, inferential language, and comprehension monitoring, (b) Words to Know, designed to unit vocabulary, (c) Integration, to teach and practice retelling, inferencing and comprehension monitoring (d) Show Me What You Know, instructors administer CAMs to monitor children's progress and (e) Stretch and Review, to provide teachers time to review key concepts. Included in the lessons are practice opportunities for students to collaborate with peers with teacher guidance and feedback. A manual provides scope of instruction, teaching strategies, lessons and materials.

Locations

Country	Name	City	State
United States	MGH Institute of Health Professions	Boston	Massachusetts
United States	The Ohio State University	Columbus	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
MGH Institute of Health Professions	National Institute on Deafness and Other Communication Disorders (NIDCD), Ohio State University, University of Kansas

Country where clinical trial is conducted

United States, 

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* Note: There are 75 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nonverbal intelligence as assessed by the Kaufman Brief Intelligence Test - Second Edition nonverbal intelligence (matrices) subtest	The nonverbal intelligence (matrices) subtest of the Kaufman Brief Intelligence Test - Second Edition measures children's ability to to solve new problems, perceive relationships and complete visual analogies without taxing language skills. The matrices subtest requires the child to point to the picture that would complete a picture or abstract design. Nonverbal intelligence will be tested as a moderator of treatment effects in analyses.	right before intervention starts
Other	Change in timed word and nonword reading, as assessed by the Test of Word Reading Efficiency - Second Edition	Change in timed word and nonword reading accuracy will be assessed by asking children to read as many words and then nonwords as possible in 45 seconds each, as measured by the Test of Word Reading Efficiency - Second Edition. Timed word and nonword reading will be tested as a moderator of treatment effects in the analyses as well as a distal treatment outcome.	right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
Other	Language comprehension skills, as assessed by the OWL Language Screener	Language comprehension skills are assessed by the The OWL Language Screener, which requires children to point to the one picture out of four pictures that best represents a sentence.This measure will be tested as a moderator of treatment effects in analyses as well as the measure to determine if the child has language weaknesses to qualify for treatment.	right before intervention starts
Other	Academic performance will be assessed by the Massachusetts or Ohio State Assessments of Reading	Children's academic reading performance will be assessed by the Massachusetts or Ohio State Reading Assessments to examine distal treatment outcomes on state assessments of reading	2 years after intervention ends
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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