Trial Outcomes & Findings for Semantic Learning Deficits in School Age Children With Developmental Language Disorder (NCT NCT04508699)

NCT ID: NCT04508699

Last Updated: 2024-12-13

Results Overview

Accuracy on the semantic learning task. Did they correctly identify when there was a meaning or did they say there was no meaning when there should have been one (incorrect response) Higher is better outcome

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 167 participants
• Primary outcome timeframe: immediately following treatment, on the same day as treatment, within 30 minutes
• Results posted on: 2024-12-13

Participant Flow

Participants were recruited from online sources (e.g., Craiglist, Facebook groups), word of mouth, clinical sites (on-campus Clinic, private clinics), local public schools, and the local University.

No events to report.

Participant milestones

Measure	Developmental Language Disorder Children with language impairment but in the absence of cognitive deficits	Typical Language Children Children with typical language development and typical cognitive development
Overall Study STARTED	15	97
Overall Study COMPLETED	13	80
Overall Study NOT COMPLETED	2	17

Reasons for withdrawal

Measure	Developmental Language Disorder Children with language impairment but in the absence of cognitive deficits	Typical Language Children Children with typical language development and typical cognitive development
Overall Study Lack of Efficacy	2	15
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Semantic Learning Deficits in School Age Children With Developmental Language Disorder

Baseline characteristics by cohort

Measure	Developmental Language Disorder n=15 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=97 Participants Children with typical language development and typical cognitive development	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	97 Participants n=7 Participants	112 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10 years STANDARD_DEVIATION 1.69 • n=5 Participants	11.7 years STANDARD_DEVIATION 2.53 • n=7 Participants	11.54 years STANDARD_DEVIATION 2.54 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	50 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	47 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	39 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	44 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	24 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	49 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	97 participants n=7 Participants	112 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately following treatment, on the same day as treatment, within 30 minutes

Population: Data analyzed from complete data sets

Accuracy on the semantic learning task. Did they correctly identify when there was a meaning or did they say there was no meaning when there should have been one (incorrect response) Higher is better outcome

Outcome measures

Measure	Developmental Language Disorder n=15 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=87 Participants Children with typical language development and typical cognitive development
Mean Percent Correct Semantic Meaning Identification Meaning condition accuracy	73.6 percentage of correct responses Standard Deviation 16.4	75.12 percentage of correct responses Standard Deviation 14.7
Mean Percent Correct Semantic Meaning Identification No meaning condition accuracy	77.1 percentage of correct responses Standard Deviation 19.5	82.3 percentage of correct responses Standard Deviation 15.2

PRIMARY outcome

Timeframe: immediately following treatment, on the same day as treatment, within 30 minutes

Population: Children with usable EEG data and matched for age

Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 1 collapsed across groups matched for age. Meaning plus condition only.

Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

Outcome measures

Measure	Developmental Language Disorder n=14 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=14 Participants Children with typical language development and typical cognitive development
N400 Amplitude - Sentence 1	-.1 microvolts Standard Deviation .002	-.27 microvolts Standard Deviation .0045

PRIMARY outcome

Timeframe: immediately following treatment, on the same day as treatment, within 30 minutes

Population: Participants with complete EEG datasets, age matched

Changes in theta band activity (measured in hertz) from sentence 1 to sentence 3, time locked to the final word in the sentence.

Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

Outcome measures

Measure	Developmental Language Disorder n=11 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=11 Participants Children with typical language development and typical cognitive development
Theta Changes	.0521 Hertz Standard Deviation .478	.121 Hertz Standard Deviation .21

PRIMARY outcome

Timeframe: immediately following treatment, on the same day as treatment, within 30 minutes

Population: Participants with usable EEG data, groups matched for age

Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 2 collapsed across groups matched for age. Meaning plus condition only.

Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

Outcome measures

Measure	Developmental Language Disorder n=14 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=14 Participants Children with typical language development and typical cognitive development
N400 Amplitude - Sentence 2	-0.1 microvolts Standard Deviation 0.005	0.075 microvolts Standard Deviation 0.003

PRIMARY outcome

Timeframe: immediately following treatment, on the same day as treatment, within 30 minutes

Population: Children with usable EEG data and matched for age

Mean amplitude (measured in microvolts) of the N400 time locked to the target word in sentence 3 collapsed across groups matched for age. Meaning plus condition only.

Smaller/more negative indicates more effortful (harder) processing and larger/more positive indicates less effortful (easier) processing.

Outcome measures

Measure	Developmental Language Disorder n=14 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=14 Participants Children with typical language development and typical cognitive development
N400 Amplitude - Sentence 3	0.221 microvolts Standard Deviation .004	.662 microvolts Standard Deviation 0.07

SECONDARY outcome

Timeframe: baseline

Population: Data analyzed from complete datasets

Full measure title: Clinical Evaluation of Language Fundamentals - 5th edition Standardized language omnibus measure Raw scores converted to t-score: 100 indicates population mean and standard deviation is 15 Higher scores indicate a better outcome and lower scores indicate a poorer outcome Typical range = 85-115; below 80 is considered in the sub-clinical range indicating the presence of a language disorder

Outcome measures

Measure	Developmental Language Disorder n=15 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=92 Participants Children with typical language development and typical cognitive development
General Language Level	73.2 t-score Standard Deviation 11.6	110.9 t-score Standard Deviation 11.86

SECONDARY outcome

Timeframe: baseline

Population: Participants with completed data sets

Full measure title: Wechsler Intelligence Scale for Children - 5th edition Nonverbal index subtests administered, considered the nonverbal subscale For the nonverbal subscale, raw scores converted to t-score: 100 indicates population mean and standard deviation is 15 Higher scores indicate a better outcome and lower scores indicate a poorer outcome Typical range = 85-115; below 70 is considered in the sub-clinical range indicating the presence of intellectual disability

Outcome measures

Measure	Developmental Language Disorder n=15 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=92 Participants Children with typical language development and typical cognitive development
Nonverbal Cognition	86.2 T-score Standard Deviation 11.2	106.93 T-score Standard Deviation 12.3

SECONDARY outcome

Timeframe: baseline

Population: Participants with complete datasets

experimental task gauging phonological memory

Outcome measures

Measure	Developmental Language Disorder n=15 Participants Children with language impairment but in the absence of cognitive deficits	Typical Language Children n=94 Participants Children with typical language development and typical cognitive development
Nonword Repetition Task	83.9 percent consonants correct Standard Deviation 9.6	92.9 percent consonants correct Standard Deviation 5.3

Adverse Events

Developmental Language Disorder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Typical Language Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

AVP for Research Support Services

San Diego State University

Phone: 619-594-5938

Email: rss@sdsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place