Clinical trial NCT03480841: Using the LENA System in Early Intervention - b
Official title: Enhancing Communication Between Children in EI and Their Depressed Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: North Carolina Translational and Clinical Sciences Institute
First posted: 2018-03-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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 Patient Health Questionnaire - (PHQ-9). This score is indicative of depressive symptoms.

Exclusion Criteria:

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

Primary outcomes:
measure: LENA Adult Word Count Score at 6 Weeks
timeFrame: at 6 weeks
Secondary outcomes:
measure: Parenting Sense of Competence Scale Efficacy Subscale Score at 6 Weeks
timeFrame: at 6 weeks
measure: Patient Health Questionnaire-9 (PHQ-9) Score at 6 Weeks
timeFrame: at 6 weeks
measure: LENA Mother/Child Turn-Taking Score at 6 Weeks
timeFrame: at 6 weeks
measure: LENA Child Vocalization Score at 6 Weeks
timeFrame: at 6 weeks
measure: Generalized Anxiety Disorder (7-Item) Score at 6 Weeks
timeFrame: at 6 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Children's Developmental Services Agency
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Linda Beeber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Anne Wheeler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Doré LaForett, PhD
role: PRINCIPAL_INVESTIGATOR
References: