Trial Outcomes & Findings for Using the LENA System in Early Intervention - b (NCT NCT03480841)

Last Updated: 2019-12-19

Results Overview

The Language Enhancement/Intervention System (LENA), which records adult-child vocalizations, measures the number of the target adult's (e.g., parent) child-directed words (child-directed speech). The total possible range is 0-n, where higher scores indicate an increased number of child-directed words spoken by the target adult and higher degrees of a language-rich environment. Lower scores indicate fewer words spoken by the target adult and represent an environment that is not language-rich.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

at 6 weeks

Results posted on

2019-12-19

Participant Flow

Interest letters describing the study were mailed from the Part C research partner to mothers in April -June 2018. Interested mothers contacted the research team by phone or email, and were then screened for eligibility. Eligible mothers completed consent forms at their homes with researchers during the Baseline visit.

Participant milestones

Participant milestones
Measure	LENA With Feedback Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
Overall Study STARTED	10
Overall Study Time 1 Data Collection (T1)	10
Overall Study LENA Baseline	10
Overall Study LENA Time 1	10
Overall Study LENA Time 2	10
Overall Study LENA Time 3	10
Overall Study LENA Time 4	9
Overall Study LENA Time 5	8
Overall Study Time 2 Data Collection (T2)	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	LENA With Feedback Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Using the LENA System in Early Intervention - b

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LENA With Feedback n=10 Participants Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.3 years STANDARD_DEVIATION 5.14 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
LENA Adult Word Count - Number of Words	12274.20 number of words STANDARD_DEVIATION 6142.03 • n=5 Participants
Parenting Sense of Competence	17.90 units on a scale STANDARD_DEVIATION 7.94 • n=5 Participants
Patient Health Questionnaire - 9	4.8 units on a scale STANDARD_DEVIATION 6.05 • n=5 Participants
LENA Mother/Child Turn Taking	416.7 number of turns STANDARD_DEVIATION 257.23 • n=5 Participants
LENA Child Vocalization	1726.00 number of vocalizations STANDARD_DEVIATION 651.35 • n=5 Participants
Generalized Anxiety Disorder - 7	4.20 units on a scale STANDARD_DEVIATION 6.07 • n=5 Participants

PRIMARY outcome

Timeframe: at 6 weeks

Outcome measures

Outcome measures
Measure	LENA With Feedback n=8 Participants Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
LENA Adult Word Count Score at 6 Weeks	18391.25 number of words Standard Deviation 8500.97

SECONDARY outcome

Timeframe: at 6 weeks

The Parenting Sense of Competence Scale is a 17-item measure assessing parental competence. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". The Efficacy subscale measures feelings of efficacy as a parent. It has 7 questions (1,6,7,10,11,13,15), producing a range of 6-42. Higher scores indicate greater self-efficacy. Lower scores mean more impairment.

Outcome measures

Outcome measures
Measure	LENA With Feedback n=8 Participants Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
Parenting Sense of Competence Scale Efficacy Subscale Score at 6 Weeks	19.00 units on a scale Standard Deviation 10.85

SECONDARY outcome

Timeframe: at 6 weeks

The Patient Health Questionnaire - 9 (PHQ-9) is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. Nine questions are scored on a range from 0-3; "0" = not at all, "1" =several days, "2" = more than half the days, and "3" = nearly every day. The total possible range is 0-27, with higher scores indicating more depressive symptoms (0-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression).

Outcome measures

Outcome measures
Measure	LENA With Feedback n=8 Participants Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
Patient Health Questionnaire-9 (PHQ-9) Score at 6 Weeks	4.25 units on a scale Standard Deviation 4.06

SECONDARY outcome

Timeframe: at 6 weeks

The LENA system, which records adult-child vocalizations, measures the number of conversational turns between the target adult (e.g., parent) and child. The total possible range is 0-n, where higher scores indicate an increased number of turns (back-and-forth, or "reciprocal" language exchanges) between the adult and child, reflecting higher degrees of a language-rich environment. Lower scores indicate fewer conversational turns between the adult and child, and represent an environment that is not language-rich.

Outcome measures

Outcome measures
Measure	LENA With Feedback n=8 Participants Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
LENA Mother/Child Turn-Taking Score at 6 Weeks	365.38 number of turns Standard Deviation 259.00

SECONDARY outcome

Timeframe: at 6 weeks

The LENA system, which records adult-child vocalizations, measures the number of vocalizations of the target child. The total possible range is 0-n, where higher scores indicate an increased number of vocalizations from the child, reflecting higher levels of language development. Lower scores indicate fewer vocalizations from child, and represent lower levels of language development.

Outcome measures

Outcome measures
Measure	LENA With Feedback n=8 Participants Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
LENA Child Vocalization Score at 6 Weeks	1199.13 number of vocalizations Standard Deviation 759.47

SECONDARY outcome

Timeframe: at 6 weeks

The Generalized Anxiety Disorder 7-item (GAD-7) is a self-report screening of anxiety symptoms examining frequency the of specific behaviors within the last two-weeks (e.g., not at all - nearly every day). A total score is calculated and compared to pre-determined cutoffs to help guide professionals in next steps for evaluation and treatment.The GAD-7 consists of seven items which are scored from zero to three. Scores range from 0-21, with higher scores reflecting more severe anxiety symptoms. The cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.

Outcome measures

Outcome measures
Measure	LENA With Feedback n=8 Participants Mothers who will run the Language ENhancement Assessment/intervention system with their young children, and will receive initial feedback from researchers on LENA output and how to enhance the home language environment. Language ENhancement Assessment/intervention system: The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
Generalized Anxiety Disorder (7-Item) Score at 6 Weeks	3.63 units on a scale Standard Deviation 4.37

Adverse Events

LENA With Feedback

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

Dr. Linda Beeber

University of North Carolina at Chapel Hill

Phone: (919) 966-8148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place