DepressionNCT03164642
Using the LENA System in Early Intervention
A study testing LENA with Feedback and LENA no feedback in people with Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- LENA with Feedback and LENA no feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2018to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Service Coordinator and Service Provider Inclusion:
- Be a CDSA employee in Durham, Wake, Alamance or Guilford Counties, NC
- Be a service coordinators or approved Speech-Language Provider(SLP) or Community Based Rehabilitative Service (CBRS) provider (service providers).
- Eligibility of the service providers will be determined by the agreement of a mother to participate in the LENA portion of the study and the agreement of the service providers to participate as well.
- Mothers Inclusion criteria:
- Be 18 years or older. Mothers who are 18 years can give consent independently.
Show all 10Show fewer
- Be the biological or adoptive mother of an infant (6 weeks - 18 months old) or toddler (19 -32 months old) enrolled in EI at the time of recruitment; mothers must be the primary caretaker of the child.
- EI services are offered only to infants and toddlers up to the age of 36 months; this study caps the age of enrollment at 32 months to ensure that toddlers are continuously enrolled in EI during the data collection period.
- Able to independently give consent. Mothers must have adequate capacity to participate in the LENA intervention as well as understand what they will be asked to do as participants.
- Score 8 or higher on the PHQ-9. This score is indicative of depressive symptoms.
Who cannot join
- Service Coordinator and Service Provider Inclusion: none
- Mothers Exclusion criteria:
- Currently pregnant by self-report.
- Child is completely deaf
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham Children's Developmental Services Agency
Durham, North Carolina, 27701
About this study
Official title: Enhancing Communication Between Children in EI and Their Depressed Mothers
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 randomized control trial using the Language ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring system, with 20 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. A "LENA with feedback" group will follow participants in the intervention over 5 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for 16 consecutive hours), with feedback during 3 weeks (baseline=LENA, no feedback; 3 week intervention=LENA with feedback; post-intervention=LENA, no feedback). A "LENA no feedback" group will complete LENA data collection at baseline on the same schedule but will not receive feedback. The main difference between groups will be provision of LENA feedback and strategies to promote increased mother-child interactions. This design allows the investigators to isolate the effect of LENA with feedback, and minimizes attributing changes in language environments due to exposure to LENA alone. 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.
Read the detailed description
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 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.
Using a randomized wait-list controlled design, the investigators will examine whether use of the LENA with feedback from a supportive EI provider has an impact on the child's language environment, parenting efficacy and maternal depressive symptoms. The investigators will stratify mothers by group based on depressive symptoms (mild, moderate, moderately severe) and randomly assign them to intervention (LENA with feedback) or wait-list control (LENA no feedback). The investigators will examine the use of the LENA system and the impact on short term child outcomes including receptive/expressive language, functional and social communication, and social-emotional behavior, and on maternal depressive symptoms. Positive intervention outcomes may ultimately lead to a sustainable addition to EI programs in all 50 US states and territories.
- Conditions
- Depression
- Being tested
- LENA with Feedback, LENA no feedback
- Keywords
- Depressive Symptoms, Developmental Disabilities, Early Intervention, Language Development, Communication, Maternal Empowerment
- Medical subject headings
- Depression, Developmental Disabilities, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LENA with FeedbackBehavioural
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. During their regular EI providers will use a standardized feedback protocol that includes emphasizing the mother's strengths, reviewing the LENA visual output from the previous recording, and asking questions to elicit how the mother can increase her child-centered and reciprocal communications during daily routines. The conversation will include concrete examples of how the mother can increase the language exchanges, encouragement, and practical ways to individually tailor the strategies to the family.
LENA no feedbackBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| LENA with Feedback | Experimental | Mothers who will run the LENA system with their young children, AND who will receive feedback from their service providers on how to enhance the language the home language environment. Receives: Behavioral: LENA with Feedback |
| LENA no feedback | Placebo comparator | Mothers who will only run the LENA system with their young children. These mothers will NOT receive feedback from their service providers on how to enhance the language the home language environment. Receives: Behavioral: LENA no feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LENA Adult Word Count score after 5 weeks
The LENA system, 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.
Measured: pre/post for a 5-week intervention window
Secondary outcomes (4)
Change in Parenting Sense of Competence Scale Efficacy subscale score after 5 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.
Measured: pre/post for a 5-week intervention window
Change in Patient Health Questionnaire-9 (PHQ-9) score after 5 weeks
The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value "0" represents not at all, "1" several days, "2" indicates more than half the days, and the maximum value "3" stands for nearly every day. The total possible range is 0-27, with higher scores indicating more depressive symptoms. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression.
Measured: pre/post for a 5-week intervention window
Change in LENA Mother/Child Turn-Taking score after 5 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.
Measured: pre/post for a 5-week intervention window
Change in LENA Child Vocalization score after 5 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.
Measured: pre/post for a 5-week intervention window
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startFeb 2018 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Determined feasibility was needed before conducting this trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Linda Beeber, PhD, Principal investigator, University of North Carolina, Chapel HillAnne Wheeler, PhD, Principal investigator, RTI InternationalDoré LaForett, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164642
- Sponsor's protocol ID
- 15-2105a
- Other IDs
- 1R03HD086330-01, 550KR141630
- Status last verified
- Feb 2018
- First submitted
- 22 May 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Communication Between Children in EI and Their Depressed Mothers
- ClinicalTrials.gov ID
- NCT03164642
- Acronym / sponsor ID
- 15-2105a
- Conditions
- Depression
- Keywords
- Depressive Symptoms, Developmental Disabilities, Early Intervention, Language Development, Communication, Maternal Empowerment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Determined feasibility was needed before conducting this trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), North Carolina Translational and Clinical Sciences Institute
- Study start
- Feb 2018 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 randomized control trial using the Language ENhancement Assessment/intervention system (LENA), a technology-supported language monitoring system, with 20 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. A "LENA with feedback" group will follow participants in the intervention over 5 weeks: 5 weeks of LENA data collection (with mothers running the system 1 day/week for 16 consecutive hours), with feedback during 3 weeks (baseline=LENA, no feedback; 3 week intervention=LENA with feedback; post-intervention=LENA, no feedback). A "LENA no feedback" group will complete LENA data collection at baseline on the same schedule but will not receive feedback. The main difference between groups will be provision of LENA feedback and strategies to promote increased mother-child interactions. This design allows the investigators to isolate the effect of LENA with feedback, and minimizes attributing changes in language environments due to exposure to LENA alone. 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.
Detailed description
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 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.
Using a randomized wait-list controlled design, the investigators will examine whether use of the LENA with feedback from a supportive EI provider has an impact on the child's language environment, parenting efficacy and maternal depressive symptoms. The investigators will stratify mothers by group based on depressive symptoms (mild, moderate, moderately severe) and randomly assign them to intervention (LENA with feedback) or wait-list control (LENA no feedback). The investigators will examine the use of the LENA system and the impact on short term child outcomes including receptive/expressive language, functional and social communication, and social-emotional behavior, and on maternal depressive symptoms. Positive intervention outcomes may ultimately lead to a sustainable addition to EI programs in all 50 US states and territories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LENA with Feedback | Experimental | Behavioral: LENA with FeedbackMothers who will run the LENA system with their young children, AND who will receive feedback from their service providers on how to enhance the language the home language environment. |
| LENA no feedback | Placebo comparator | Behavioral: LENA no feedbackMothers who will only run the LENA system with their young children. These mothers will NOT receive feedback from their service providers on how to enhance the language the home language environment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be a CDSA employee in Durham, Wake, Alamance or Guilford Counties, NC
- Be a service coordinators or approved Speech-Language Provider(SLP) or Community Based Rehabilitative Service (CBRS) provider (service providers).
- Eligibility of the service providers will be determined by the agreement of a mother to participate in the LENA portion of the study and the agreement of the service providers to participate as well.
- Be 18 years or older. Mothers who are 18 years can give consent independently.
- Be the biological or adoptive mother of an infant (6 weeks - 18 months old) or toddler (19 -32 months old) enrolled in EI at the time of recruitment; mothers must be the primary caretaker of the child.
Key exclusion criteria (4 listed)
- Service Coordinator and Service Provider Inclusion: none
- Currently pregnant by self-report.
- Child is completely deaf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LENA with FeedbackThe 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. During their regular EI providers will use a standardized feedback protocol that includes emphasizing the mother's strengths, reviewing the LENA visual output from the previous recording, and asking questions to elicit how the mother can increase her child-centered and reciprocal communications during daily routines. The conversation will include concrete examples of how the mother can increase the language exchanges, encouragement, and practical ways to individually tailor the strategies to the family. | Behavioural | LENA with Feedback |
| LENA no feedbackThe 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 | Behavioural | LENA no feedback |
Primary outcome
Change in LENA Adult Word Count score after 5 weeks
Time frame: pre/post for a 5-week intervention window
The LENA system, 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.
4 secondary outcomes
Change in Parenting Sense of Competence Scale Efficacy subscale score after 5 weeks
Time frame: pre/post for a 5-week intervention window
Change in Patient Health Questionnaire-9 (PHQ-9) score after 5 weeks
Time frame: pre/post for a 5-week intervention window
Change in LENA Mother/Child Turn-Taking score after 5 weeks
Time frame: pre/post for a 5-week intervention window
Change in LENA Child Vocalization score after 5 weeks
Time frame: pre/post for a 5-week intervention window
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Beeber, PhD principal investigator
University of North Carolina, Chapel Hill
Anne Wheeler, PhD principal investigator
RTI International
Doré LaForett, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LENA with Feedback and LENA no feedback in people with Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LENA Adult Word Count score after 5 weeks (time frame: pre/post for a 5-week intervention window). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.