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Using the LENA System in Early Intervention - b

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ClinicalTrials.gov Identifier: NCT03480841
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Language ENhancement Assessment/intervention system Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Communication Between Children in EI and Their Depressed Mothers
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : November 4, 2018
Actual Study Completion Date : November 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 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.




Primary Outcome Measures :
  1. Change in LENA Adult Word Count score after 6 weeks [ Time Frame: pre/post for a 6-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.


Secondary Outcome Measures :
  1. Change in Parenting Sense of Competence Scale Efficacy subscale score after 6 weeks [ Time Frame: pre/post for a 6-week intervention window ]
    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.

  2. Change in Patient Health Questionnaire-9 (PHQ-9) score after 6 weeks [ Time Frame: pre/post for a 6-week intervention window ]
    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.

  3. Change in LENA Mother/Child Turn-Taking score after 6 weeks [ Time Frame: pre/post for a 6-week intervention window ]
    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.

  4. Change in LENA Child Vocalization score after 6 weeks [ Time Frame: pre/post for a 6-week intervention window ]
    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.

  5. Change in Generalized Anxiety Disorder (7-Item) score after 6 weeks [ Time Frame: pre/post for a 6-week intervention window ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • Currently pregnant by self-report.
  • Child is completely deaf

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480841


Locations
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United States, North Carolina
Durham Children's Developmental Services Agency
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
North Carolina Translational and Clinical Sciences Institute
Investigators
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Principal Investigator: Linda Beeber, PhD University of North Carolina, Chapel Hill
Principal Investigator: Anne Wheeler, PhD RTI International
Principal Investigator: Doré LaForett, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03480841     History of Changes
Other Study ID Numbers: 15-2105b
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No