Clinical trial NCT06945289: Efficacy of Let's Know! First Grade
Official title: Efficacy of Let's Know! for Improving Oral Language in First Grade Students
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Developmental Language Disorder and Language Impairment
Keywords: developmental language disorder
language intervention
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oral language skills are vital for reading comprehension. Some children, however, are at increased risk for reading comprehension difficulties due to underlying oral language deficits. School-based interventions that target children's abilities to understand and produce spoken language have shown positive effects for improving language and reading comprehension of children with typical development and those at-risk for language disorders, so it is likely that they will benefit children with low oral language skills.

The purpose of this study is to examine the efficacy of a small-group intervention for improve language skills in first grade students with low oral language skills.

Detailed description: Oral language skills, which consist of both lower-level (vocabulary and grammar) and higher-level skills (inferencing, comprehension monitoring, and text structure knowledge) are crucial for reading comprehension. Children with low oral language skills are at increased risk for negative academic outcomes due to their deficits in understanding and producing language. Multi-component interventions have shown positive effects for improving language comprehension and reading comprehension outcomes of children with typical development and at-risk for language and literacy disorders, and thus may benefit children with low oral language skills.

The purpose of this study is to examine the efficacy of Let's Know!, a small group multi-component intervention, for improving language comprehension skills in first-grade students with low oral language skills. A randomized controlled trial will be employed to compare the language comprehension outcomes for a treatment group compared to a business-as-usual control group.

Eligibility criteria: Inclusion Criteria:

* enrolled in first-grade;
* receive a score of below than 5 on two items on the Student Language Scale (Nelson et al., 2018) or be receiving school speech-language services for language impairment;
* be proficient in English, per caregiver report;
* have no other neurological impairments (e.g., intellectual disability, autism) per parent report;
* have corrected vision;
* no hearing impairment.

Exclusion Criteria:

* cannot be enrolled in English-Language Learner services in the school.

Primary outcomes:
measure: Curriculum-Aligned Vocabulary Measure
timeFrame: From enrollment to the end of treatment at 10 weeks of intervention.
measure: Curriculum-Aligned Inferencing Measure
timeFrame: From enrollment to the end of treatment at 10 weeks of intervention.
measure: Curriculum-Aligned Comprehension Monitoring Measure
timeFrame: From enrollment to the end of treatment at 10 weeks of intervention.
measure: Curriculum-Aligned Text Structure Knowledge Measure
timeFrame: From enrollment to the end of treatment at 10 weeks of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: