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Language Intervention for Language Disorder

N/A
Waitlist Available
Led By Karla K McGregor, Ph.D.
Research Sponsored by Karla McGregor
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within three weeks following end of instruction
Awards & highlights

Study Summary

This trial will test the efficacy of a science-relevant language intervention on the learning of science concepts in young children with SLI.

Eligible Conditions
  • Language Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within three weeks following end of instruction
This trial's timeline: 3 weeks for screening, Varies for treatment, and within three weeks following end of instruction for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Language Outcomes
Targeted science content outcomes
Secondary outcome measures
Generalized Science Outcomes

Side effects data

From 2022 Phase 2 trial • 110 Patients • NCT02920892
44%
Upper Respiratory Tract Infection
34%
Insomnia
26%
irritability
16%
Otitis Media
14%
Diarrhea
12%
Aggression
12%
Sleep Disorder
10%
Psychomotor Hyperactivity
8%
Vomiting
8%
Agitation
8%
Pyrexia
6%
Anxiety
6%
Sensory Processing Disorder
6%
Gastroenteritis
6%
Attention Deficit Hyperactivity Disorder
6%
Perseveration
6%
Cough
6%
Pharyngitis Streptococcal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-Blind Period: AFQ056 With Language Intervention
Open-Label Period: AFQ056 With Language Intervention
Placebo Lead-In Period
Double-Blind Period: Placebo With Language Intervention

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Science + Vocabulary InterventionExperimental Treatment1 Intervention
Vocabulary: This arm will provide Robust Vocabulary Instruction, an explicit approach that emphasizes multiple and rich encounters in authentic contexts to promote depth of semantic knowledge of 12 words that pertain to scientific practices applicable to the FOSS lessons. The words are: compare, diagram, evidence, explanation, hypothesis, materials, model, multiple, pattern, problem, scientist, search. Two words will be targets in each session. The examiners will ensure that for each target word per session there will be at least one definition model and 3 other models directed to the triad of participants and at least 2 elicitations per child. The recorded books also include 6 additional exposures to the words, for a cumulative exposure of 12.
Group II: Science + Grammar InterventionExperimental Treatment1 Intervention
Grammar: In the science + grammar condition, focused stimulation plus explicit instruction will be employed. Focused stimulation an intervention commonly used to target expressive language, will be used to treat complement clauses during the FOSS activities.. The active ingredients are models (30) and recasts (5 per child) of the target structure (e.g., "You measured how long the ramp is"). Recasts occur when an examiner responds to a child's naturally occurring utterance by expanding or extending the child's utterance to include a target grammatical structure. Focused stimulation will be supplemented with explicit instruction using choral production and visual supports (3x per lesson) and a definition of the meaning of the structure (1 per lesson).
Group III: ControlActive Control1 Intervention
Control: In all conditions, the examiners will teach science using the Full Option Science System Next Generation Edition (FOSS, 2015, https://www.fossweb.com/) curriculum that involves 1) Prediction, 2) Experiment, 3) a visual Journal/Reflection, and 4) a pre-recorded reading centered around a given theme such as sound. A research speech-language pathologist will provide two 30-minute interactive science lessons per week for six weeks to children with language learning challenges recruited nationwide. Children will participate in groups of three. Families will log on five additional times during each week to view the science book reading. In the control condition, children will receive these science lessons but no language intervention. Therefore, this intervention constitutes a nonintervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Language Intervention
2021
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Karla McGregorLead Sponsor
University of IowaOTHER
446 Previous Clinical Trials
879,470 Total Patients Enrolled
University of DelawareOTHER
154 Previous Clinical Trials
25,179 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there open vacancies for participants in this research endeavor?

"This medical study is currently recruiting suitable applicants, with initial postings on September 1st 2021 and the latest update taking place on July 19th 2022. This data can be found on clinicaltrials.gov."

Answered by AI

What is the current enrollment capacity of this scientific study?

"Affirmative. Clinicaltrials.gov outlines that this clinical trial is open for recruitment, which it first posted on September 1st 2021 and most recently updated on July 19th 2022. This study seeks to enrol 63 individuals from one specific location."

Answered by AI

Who qualifies for enrollment in this clinical trial?

"This current study is looking to enrol 63 participants, aged between 4 and 7 with speech delay. Furthermore, these potential patients must have attained a standard score of below 85 on the DELV-NR (Seymour et al., 2005), achieved t scores greater than or equal to 35 in DAS-II (Elliott, 2007) tests, demonstrate proficiency in simple sentences formation, be yet to begin first grade schooling and display lower than 40% accuracy when attempting expressive probes of complement clauses before their participation commences."

Answered by AI

Does this trial encompass individuals above the age of twenty-five?

"This trial is recruiting children aged 4 to 7 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Improving STEM Outcomes for Young Children With Language Learning Disabilities Via Telehealth
Karla McGregor 2021. "Improving STEM Outcomes for Young Children With Language Learning Disabilities Via Telehealth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04775199.
~8 spots leftby Apr 2025
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