Using the LENA System in Early Intervention

NCT03164642 | Withdrawn

• 3 other identifiers: 15-2105a1R03HD086330-01550KR141630
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression

Keywords

Depressive Symptoms; Developmental Disabilities; Early Intervention; Language Development; Communication; Maternal Empowerment

Outcome Measures

Primary Outcomes (1)

• 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.

  pre/post for a 5-week intervention window

Secondary Outcomes (4)

• Change in Parenting Sense of Competence Scale Efficacy subscale score after 5 weeks

  pre/post for a 5-week intervention window

• Change in Patient Health Questionnaire-9 (PHQ-9) score after 5 weeks

  pre/post for a 5-week intervention window

• Change in LENA Mother/Child Turn-Taking score after 5 weeks

  pre/post for a 5-week intervention window

• Change in LENA Child Vocalization score after 5 weeks

  pre/post for a 5-week intervention window

Study Arms (2)

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.

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.

Behavioral: LENA no feedback

Interventions

LENA with Feedback BEHAVIORAL

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 with Feedback

LENA no feedback BEHAVIORAL

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

LENA no feedback

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

Durham Children's Developmental Services Agency

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Depression; Developmental Disabilities; Communication

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: February 1, 2018
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)