N/A
N=10
Using the LENA System in Early Intervention - b
Depression
Bottom Line
View on ClinicalTrials.gov: NCT03480841 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: LENA Adult Word Count Score at 6 Weeks — 18391.25 number of words
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Language ENhancement Assessment/intervention system (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LENA Adult Word Count Score at 6 Weeks |
18391.25 | — |
| SECONDARY Parenting Sense of Competence Scale Efficacy Subscale Score at 6 Weeks |
19.00 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) Score at 6 Weeks |
4.25 | — |
| SECONDARY LENA Mother/Child Turn-Taking Score at 6 Weeks |
365.38 | — |
| SECONDARY LENA Child Vocalization Score at 6 Weeks |
1199.13 | — |
| SECONDARY Generalized Anxiety Disorder (7-Item) Score at 6 Weeks |
3.63 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03480841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.