An interventional study of Language ENhancement Assessment/intervention system in Depression, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
This project will determine whether an intervention to enhance communication between infants and toddlers with developmental disabilities and their depressed mothers can be integrated into federally-funded Early Intervention (EI) services. Participants will be mothers with depressive symptoms whose children are receiving EI services, along with their EI service providers.
The investigators will conduct a small feasibility trial using the Language ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring system, with 10 mothers and one of their child's EI service providers. The LENA uses an infant or toddler garment with an integrated audiotape system that records adult speech centered on the child, child vocalizations, and reciprocal parent-child turn-taking conversations. The LENA software produces visual feedback that a mother can use to focus her language interactions with her child. They study will follow participants in the LENA with feedback intervention over 6 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for 16 consecutive hours). The investigators will analyze data from measures on LENA communication data (adult word count, child vocalizations and conversational turn-taking), and measures of child language, maternal depressive symptoms, and child disability profiles.
Early Intervention (EI) services are provided to infants and toddlers with documented developmental delays in all 50 states and US territories. EI improves long-term infant-toddler adaptation and lowers the cost of care if parents use the services. However, depressive symptoms can reduce mothers' ability to provide the daily child development-promoting activities recommended by EI, increasing the child's risk for communication and behavioral problems. Indeed, repeated studies have shown that depressive symptoms reduce mothers' consistent use of developmentally sensitive, child-centered speech which, in turn, lead to negative child cognitive and behavioral outcomes. Previous research showed that over one-third of mothers of children with disabilities have significant levels of depressive symptoms, a rate higher than the population at large. Infants and toddlers of depressed mothers have been shown to receive fewer intensive services and have been shown to interfere with uptake of EI services through impaired mother-child interactions. A preliminary study by the investigators found that over a third of mothers of infants and toddlers enrolled in EI in a large North Carolina county had severe depressive symptoms and depression histories. Fortunately, the investigators also found that when depressed mothers were provided with concrete, attainable skills for improving interactions with their child, the impact of depression on both mother and child was substantially reduced. Focusing on a depressed mother's child-centered speech and reciprocal communication also improves child outcomes, even when the child is cognitively compromised. However, none of these specialized services are part of EI best practices. Thus, EI is an ideal setting in which to integrate screening, referral and targeted skills for depressed mothers in order to improve parent-child interactions and ultimately, child outcomes.
This project will develop an intervention focused on communication between infants and toddlers with diagnosed or suspected developmental disabilities and their mothers who have depressive symptoms. The primary aim of the study is to test the feasibility and initial efficacy of embedding a language pedometer, the Language ENhancement Assessment/intervention system (LENA), into EI to teach mothers to increase child-centered speech and reciprocal communication, which have been linked to positive child outcomes, and to increase parenting efficacy in depressed mothers of children in EI.
While maternal depressive symptoms can disrupt developmentally stimulating, child-centered speech, simple tools to assess and provide feedback to mothers can improve the child-centered speech and reciprocal language interactions that positively impact child outcomes. Although the LENA has been used in other studies and shown improvements in mothers' child-centered speech, the system has not been used with mothers showing depressive symptoms or in the EI context. The investigators will examine the efficacy of using LENA in a pre-/post-intervention design. Specifically, the investigators will examine whether mothers' primarily independent use of the LENA with feedback has an impact on the child's language environment, parenting efficacy and maternal depressive symptoms.
The investigators will also conduct follow up data collection with participating mothers, which will be approximately 6 months after her last LENA recording. Follow up activities will involve having the mother conduct one more LENA recording and provide survey information over the phone, which will allow the investigators to determine residual effects of the study interventions, additional demographic information, and feedback for future studies.
Exclusion Criteria:
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 language the home language environment.
Behavioral: 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
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.
Time frame: at 6 weeks
Parenting Sense of Competence Scale Efficacy Subscale Score 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.
Time frame: at 6 weeks
Patient Health Questionnaire-9 (PHQ-9) Score 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).
Time frame: at 6 weeks
LENA Mother/Child Turn-Taking Score 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.
Time frame: at 6 weeks
LENA Child Vocalization Score 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.
Time frame: at 6 weeks
Generalized Anxiety Disorder (7-Item) Score 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.
Time frame: at 6 weeks
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.
| Milestone | LENA With Feedback |
|---|---|
| Started | 10 |
| Time 1 data collection (t1) | 10 |
| Lena baseline | 10 |
| Lena time 1 | 10 |
| Lena time 2 | 10 |
| Lena time 3 | 10 |
| Lena time 4 | 9 |
| Lena time 5 | 8 |
| Time 2 data collection (t2) | 8 |
| Completed | 8 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
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.
| number of words | LENA With Feedback |
|---|---|
| LENA Adult Word Count Score at 6 Weeks | 18391.25 ± 8500.97 |
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.
| units on a scale | LENA With Feedback |
|---|---|
| Parenting Sense of Competence Scale Efficacy Subscale Score at 6 Weeks | 19.00 ± 10.85 |
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).
| units on a scale | LENA With Feedback |
|---|---|
| Patient Health Questionnaire-9 (PHQ-9) Score at 6 Weeks | 4.25 ± 4.06 |
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.
| number of turns | LENA With Feedback |
|---|---|
| LENA Mother/Child Turn-Taking Score at 6 Weeks | 365.38 ± 259.00 |
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.
| number of vocalizations | LENA With Feedback |
|---|---|
| LENA Child Vocalization Score at 6 Weeks | 1199.13 ± 759.47 |
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.
| units on a scale | LENA With Feedback |
|---|---|
| Generalized Anxiety Disorder (7-Item) Score at 6 Weeks | 3.63 ± 4.37 |
Collected over Beginning at screening call and up to 6 months after T2 data collection (e.g., an average of 1 year). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LENA With Feedback | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | LENA With Feedback |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | LENA With Feedback |
|---|---|
| Mean | 37.3 ± 5.14 |
| Sex: Female, Male(Participants) | LENA With Feedback |
|---|---|
| Female | 10 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | LENA With Feedback |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | LENA With Feedback |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | LENA With Feedback |
|---|---|
| United States | 10 |
| LENA Adult Word Count - Number of Words(number of words) | LENA With Feedback |
|---|---|
| Mean | 12274.20 ± 6142.03 |
| Parenting Sense of Competence(units on a scale) | LENA With Feedback |
|---|---|
| Mean | 17.90 ± 7.94 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill