Depression Clinical Trial
Official title:
Enhancing Communication Between Children in EI and Their Depressed Mothers
NCT number | NCT03480841 |
Other study ID # | 15-2105b |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2, 2018 |
Est. completion date | November 4, 2018 |
Verified date | February 2019 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 4, 2018 |
Est. primary completion date | November 4, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Durham Children's Developmental Services Agency | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
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 |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LENA Adult Word Count Score at 6 Weeks | The Language Enhancement/Intervention System (LENA), 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. | at 6 weeks | |
Secondary | Parenting Sense of Competence Scale Efficacy Subscale Score at 6 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. | at 6 weeks | |
Secondary | Patient Health Questionnaire-9 (PHQ-9) Score at 6 Weeks | The Patient Health Questionnaire - 9 (PHQ-9) is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. Nine questions are scored on a range from 0-3; "0" = not at all, "1" =several days, "2" = more than half the days, and "3" = nearly every day. The total possible range is 0-27, with higher scores indicating more depressive symptoms (0-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression). | at 6 weeks | |
Secondary | LENA Mother/Child Turn-Taking Score at 6 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. | at 6 weeks | |
Secondary | LENA Child Vocalization Score at 6 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. | at 6 weeks | |
Secondary | Generalized Anxiety Disorder (7-Item) Score at 6 Weeks | 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.The GAD-7 consists of seven items which are scored from zero to three. Scores range from 0-21, with higher scores reflecting more severe anxiety symptoms. The cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively. | at 6 weeks |
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