Enhancing Communication Between Children in EI and Their Depressed Mothers
Phase: NA
Conditions: Depression
Sponsor: University of North Carolina, Chapel Hill

Intervention protocol template_Draft_29AUG2016 
 
 
Study Title: Enhancing Communication Between Children in EI and Their Depressed Mothers 
 
 
 
NCT number:  NCT03480841 
Document Date:  10/12/2019 
 
 
 

Intervention protocol template_Draft_29AUG2016 
 
PROTOCOL TEMPLATE: INTERVENTIONAL STUDY 
 
 
Complete Title: Enhancing Communication Between Children in EI and Their Depressed Mothers 
 
 
Short Title: Using the LENA System in Early Intervention - b 
Drug or Device Name(s): NA 
FDA IND/IDE (if applicable): NA 
Sponsor: University of North Carolina, Chapel Hill 
Protocol Date: 10/12/2019 
Amendment 1 Date: NA 
Amendment 2 Date: NA 
Amendment 3 Date: NA 
Amendment 4 Date: NA 
 
 
 
 
 
Sponsor (IND or IDE holder, if applicable) 
North Carolina Translational & Clinical Sciences Institute 
Brinkhous-Bullitt Building, CB#7064 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 25799-7064 
USA 
 
Linda Beeber, Ph.D., PMHCNS-BC 
The University of North Carolina at Chapel Hill 
 School of Nursing 
 Carrington Hall, CB #7460 
 Chapel Hill, NC 27599-7460 
Phone: 919-966-8148 
email: beeber@email.unc.edu 
 
 
 
 
 

Intervention protocol template_Draft_29AUG2016 
 
PROTOCOL TITLE:  
Enhancing Communication Between Children in EI and Their Depressed Mothers 
Short Title:  
 
Using the LENA System in Early Intervention - b 
 
Lead Investigator: 
Linda Beeber, Ph.D., PMHCNS-BC 
 University of North Carolina at Chapel Hill 
Protocol Version: 1.0  
Version Date: October 12, 2019 
 
I confirm that I have read this protocol and understand it.    
Principal Investigator Name:  
 
 
Linda S. Beeber  
 
 
 
Principal Investigator Signature:  
 
 
Date:   
 
 
 
10/12/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Intervention protocol template_Draft_29AUG2016 
 
TABLE OF CONTENTS 
Table of Contents ........................................................................................................... 4 
Abbreviations and Definitions of Terms .......................................................................... 6 
Protocol Synopsis ........................................................................................................... 7 
1 
BACKGROUND AND RATIONALE .................................................................................................................... 9 
2. STUDY OBJECTIVE ......................................................................................................................................... 10 
3. INVESTIGATIONAL PLAN (BRIEF OVERVIEW) ................................................................................................ 10 
4. STUDY PROCEDURES (WHAT WILL BE DONE) .............................................................................................. 11 
5. STUDY EVALUATIONS AND MEASUREMENTS (HOW MEASUREMENTS WILL BE MADE) ............................. 12 
6. STATISTICAL CONSIDERATION ...................................................................................................................... 14 
7. STUDY INTERVENTION (DRUG, DEVICE OR OTHER INTERVENTION DETAILS) .............................................. 14 
8. STUDY INTERVENTION ADMINISTRATION(IF APPLICABLE) .......................................................................... 14 
9. SAFETY MANAGEMENT ................................................................................................................................ 14 
10. DATA COLLECTION AND MANAGMENT ....................................................................................................... 15 
11. RECRUITMENT STRATEGY ............................................................................................................................ 15 
12. CONSENT PROCESS ...................................................................................................................................... 16 
13. PLANS FOR PUBLICATION ............................................................................................................................. 16 
14. REFERENCES ................................................................................................................................................. 16 
15      APPENDIX .................................................................................................................................................. 17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
Abbreviation 
Definition 
EI 
Early Intervention 
LENA 
Language Enhancement/Intervention System 
PSOC 
Parenting Sense of Competence 
PHQ-9 
Patient Health Questionnaire – 9 
GAD-7 
Generalized Anxiety Disorder – 7 item 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Intervention protocol template_Draft_29AUG2016 
 
PROTOCOL SYNOPSIS 
 
Study Title 
Enhancing Communication Between Children in EI and Their 
Depressed Mothers 
Funder 
North Carolina Translational and Clinical Sciences Institute, 
University of North Carolina at Chapel Hill 
Clinical Phase 
NA 
Study Rationale 
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. 
Study Objective(s) 
Primary  
• 
To test the feasibility and initial efficacy of embedding a 
language pedometer, the Language ENhancement 
Assessment/Intervention system (LENA) into Early Intervention 
(EI) to teach mothers to increase child-centered speech and 
reciprocal communication.  
Test Article(s) 
(If Applicable) 
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 in the home language environment. The 
intervention involves mothers independently running the LENA 
system, an audio recorder 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, 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. 
Study Design 
 
The investigators will examine the efficacy of using LENA in a pre-
/post intervention design, where mothers will run the LENA for 1 
day a week for a total of 6 weeks. Outcome measures will be 
collected prior to the first LENA recording and again after the final 
recording.  
Subject Population 
Inclusion Criteria 
1. Subjects age 18-99 years 

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key criteria for Inclusion 
and Exclusion: 
2. 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 
3. Able to give consent independently, and must have 
adequate capacity to participate in the LENA intervention as 
well as understand what they will be asked to do as 
participants. 
Exclusion Criteria 
1. Currently pregnant by self-report 
2. Child is completely deaf 
Number Of Subjects  
 
10  
Study Duration 
Each subject’s participation will last approximately 2 months. 
The entire study is expected to last 12 months. 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
(1) Screening: screening for eligibility, (2) Enrollment/Baseline: 
obtaining consent and conducting Time 1 outcome measures prior 
to intervention, (3) Intervention: study intervention using the 
LENA, and (4) Post-test/Analysis: Time 2 outcome measures after 
intervention and analysis 
Efficacy Evaluations 
Primary evaluation measure that will be used to assess the efficacy 
of the intervention is the LENA Adult Word Count. 
Pharmacokinetic 
Evaluations 
NA 
Safety Evaluations 
The MPIs will regularly monitor the study and data collection 
procedures and meet with the EI staff to review the protocols for 
safety and confidentiality. Drs. Beeber and Meltzer-Brody will 
constantly monitor mothers whose depressive symptoms worsen 
and will arrange for immediate assessment if needed. 
Statistical And Analytic 
Plan 
Due to the small sample size and the feasibility/exploratory nature 
of the research questions, analyses will be descriptive only (means, 
standard deviations and/or frequencies). 
DATA AND SAFETY 
MONITORING PLAN 
The safety plan is described above. For management of data 
quality, Dr. LaForett will work with Dr. Okoniewski, Ms. Salomon, 
and staff keying data to ensure data management activities (initial 
data cleaning, double keying, error checking and error corrections, 
and data validation) are conducted. 
 
 
 

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1 
BACKGROUND AND RATIONALE 
1.1 
Introduction 
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, leads to negative child cognitive and behavioral outcomes.  
1.2 
Name and Description of Investigational Product or Intervention  
The Language ENhancement Analysis (LENA; www.lenafoundation.org) system uses a non-invasive 
wearable sensor that (i) records language input and output, and (ii) provides visual feedback. When 
paired with simple tips for improving verbal input, it increases the quantity and quality of adult-child 
verbal interactions (Suskind et al., 2013). LENA is a validated tool for assessing adult and child speech 
and reciprocal interactions (Xu et al., 2009). The LENA system quantifies the number of words a child is 
exposed to, and the number of conversational turns between a child and adults over a 16-hour period 
(Gilkerson & Richardson, 2008). The LENA uses a shirt, vest or infant one-piece garment with an 
integrated audiotape device that records adult speech centered on the child, child vocalizations, and 
reciprocal turn-taking conversations between parent and child. Environmental noise (e.g., TV, non-
caretaker speech) also can be recorded and analyzed in segments by LENA software. The quantified 
“language environment” is presented in a series of graphs which can be shown to parents to assist with 
goal setting. A “biofeedback” intervention model combines the visual data provided by LENA with 
customized “talking tips” for increasing adult word count and conversational turn taking 
(http://www.providencetalks.org/wp-content/uploads/2015/09/Binder1.pdf), which in turn results in 
improved reciprocal communication.  
1.3 
Non-Clinical and Clinical Study Findings 
This LENA intervention model showed success in increasing adult language production in parents of 
typically developing children (Suskind et al., 2013). In addition, LENA has been used successfully to 
document exposure to adult language in parent-child dyads in low-income families (Weisleder & 
Fernald, 2013), children with hearing loss (Caskey & Vohr, 2013), newborns in NICUs (Caskey et al., 
2014), and in children with autism (Irvin et al., 2013; Yoder et al., 2013), and Down syndrome 
(Thiemann-Bourque et al., 2014). However, none of these studies explicitly explored the language 
environments of children with disabilities and mothers with depression, or “dually vulnerable” dyads, 
and no studies have addressed the use of LENA as an embedded tool within existing EI systems. 
There are no known or expected risks to using the LENA system. 
1.4 
Relevant Literature and Data 
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 

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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 in a large North Carolina county had severe 
depressive symptoms and depression histories. Fortunately, 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 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. 
For the measures used to evaluate the efficacy of the LENA intervention, all have established reliability 
and validity: LENA adult word count, turn-taking, and child vocalizations (Xu, 2009); Parenting Sense of 
Competence (PSOC: Gilmore & Cuskelly, 2008); Patient Health Questionnaire – 9 (PHQ-9: Kronenke et 
al., 2001); Generalized Anxiety Disorder – 7 items (GAD-7: Spitzer et al., 2006). 
2. 
STUDY OBJECTIVE  
This project seeks to test the efficacy of this type of maternal-child focused intervention, using the 
LENA intervention embedded in EI to help mothers enhance their child-centered speech and reciprocal 
communication.  
2.1 
Primary Objective 
The primary objective of the study is to test the feasibility and initial efficacy of embedding a language 
pedometer, the Language ENhancement Assessment/Intervention system (LENA) into Early 
Intervention (EI) to teach mothers to increase child-centered speech and reciprocal communication.  
 
2.2 
Secondary Objective - NA 
 
3. 
INVESTIGATIONAL PLAN (brief overview) 
3.1 Study Design 
Type of design: Single group assignment, pre-/post-intervention 
Provide brief overview of the study phases:  
- 
Screening: screening for eligibility 
- 
Enrollment/Baseline: obtaining consent and conducting Time 1 outcome measures prior to 
intervention 
- 
Intervention: study intervention using the LENA 
- 
Post-test/Analysis: Time 2 outcome measures after intervention and analysis 
 
3.2 Allocation to Treatment Groups and Blinding (if applicable): NA 
 

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3.3 Study Duration, Enrollment and Number of Subjects 10 subjects will participate in the study. Each 
subject’s participation will last approximately 2 months. The entire study is expected to last 12 months. 
 
3.4 Study Population 
Inclusion Criteria 
• Subjects age 18-99 years 
• 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 
• Able to give consent independently, and must have adequate capacity to participate in the 
LENA intervention as well as understand what they will be asked to do as participants. 
Exclusion Criteria 
o Currently pregnant by self-report 
o Child is completely deaf 
 
4. 
STUDY PROCEDURES (what will be done) 
4.1 Screening procedures 
Interest letters describing the study will be mailed from our Part C research partner to mothers in April 
-June 2018. Interested mothers will contact the research team by phone or email to schedule a time to 
screen them for eligibility for the study. Screenings will be done via phone by a research team member 
who will administer the PHQ-9 and collect demographic information.  
 
4.2 Enrollment/Baseline Visit procedures 
For eligible mothers, researchers will schedule a home visit to go over enrollment procedures (i.e., 
complete consent forms). Enrolled mothers and their child who was the target for the study will 
complete the pre-test (Time 1) measures: the PHQ-9, the Parenting Sense of Competence, and the 
GAD-7. At this visit, mothers will be given written instructions and a video tutorial on how use the 
LENA system. The research team will leave the LENA recorder, clothing, and pre-stamped/addressed 
envelopes for the mother to mail the LENA recorder to the study team after the first recording was 
completed. 
 
4.3 Intervention/Treatment procedures (by visits) 
Mothers will run the Language Enhancement Assessment/intervention system with their young child 
for the first time for one day up to 16 hours and will mail the recorder back to the research team. 
Researchers will provide an initial feedback session, 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 for 5 
additional recordings over 5 weeks, again mailing each recorder back to the team after the receiving it 
again from the research team once the recording is uploaded to the LENA system. 
 

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4.4 Post-test/Analysis procedures (by visits) 
Once the final recording is returned, researchers will schedule a home visit to complete the post-test 
(Time 2) measures: the PHQ-9, the Parenting Sense of Competence, and the GAD-7. 
Researchers will conduct descriptive analyses including means, standard deviation and/or frequencies. 
4.5 Unscheduled visits NA 
 
4.6 Concomitant Medication documentation NA 
 
4.7 Rescue medication administration (if applicable) NA 
 
4.8 Subject Completion/ Withdrawal procedures 
 
Once recordings were completed an exit interview was conducted.  Upon completion of this interview 
incentives were mailed to participants and subject participation was considered complete. 
 
4.9 Screen failure procedures  
We did not have any screen failures. 
 
5. 
STUDY EVALUATIONS AND MEASUREMENTS (how measurements will be 
made)   
5.1 Efficacy Evaluation (if applicable) 
The following measures will be used to evaluate feasibility and efficacy of the LENA intervention; LENA 
data will be derived from the LENA audio recording. All other measures are collected using maternal 
self-report. 
Primary: 
• Change in LENA Adult Word Count after 6 weeks: The LENA system, which records adult-child 
vocalizations, measures the number of the target adult's (e.g., parent's) 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: 
• Change in Parenting Sense of Competence Scale after 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. 

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• Change in the Patient Health Questionnaire – 9 after 6 weeks: 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. 
• Change in LENA Mother/Child Turn Taking after 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 and 
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. 
• Change in LENA Child Vocalization after 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 the child, and represent lower levels of language development. 
• Change in GAD-7 after 6 weeks: The Generalized Anxiety Disorder 7-item (GAD-7) is a self-
report screening of anxiety symptoms examining frequency of the 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. 
 
5.2 Pharmacokinetic Evaluation (if applicable) NA 
 
5.3 Safety Evaluations 
 
The Co-PIs will review any questionable situation immediately; the research team will review all data 
collections weekly. 
 
The MPIs will regularly monitor the study and data collection procedures and meet with the EI staff to 
review the protocols for safety and confidentiality. Drs. Beeber and Meltzer-Brody will constantly 
monitor mothers whose depressive symptoms worsen and will arrange for immediate assessment if 
needed. 
 

Intervention protocol template_Draft_29AUG2016 
 
6. 
STATISTICAL CONSIDERATION   
Researchers will conduct descriptive analyses including means, standard deviation and/or frequencies. 
Our sample size of 8 mothers does not allow us to test pre/post changes. Nonetheless, this descriptive 
information will give us an initial sense of the feasibility and efficacy of the LENA intervention. 
6.1 Primary Endpoint 
The primary endpoint is 6 weeks after the LENA intervention. 
6.2 Secondary Endpoint - NA 
 
6.3 Statistical Methods 
Researchers will conduct descriptive analyses including means, standard deviation and/or frequencies. 
Our sample size of 8 mothers does not allow us to test pre/post changes. Nonetheless, this descriptive 
information will give us an initial sense of the feasibility and efficacy of the LENA intervention. 
6.4 Sample Size and Power 
The sample size of 10 mothers is adequate to examine initial feasibility. 
 
6.5 Interim Analysis - NA 
 
7. 
STUDY INTERVENTION (drug, device or other intervention details) 
Mothers will run the Language Enhancement Assessment/intervention system with their young child 
for the first time for one day up to 16 hours and will mail the recorder back to the research team. 
Researchers will provide an initial feedback session, 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 for 5 
additional recordings over 5 weeks, again mailing each recorder back to the team after the receiving it 
again from the research team once the recording is uploaded to the LENA system. 
 
8. 
STUDY INTERVENTION ADMINISTRATION(if applicable)  
NA 
 
9. 
SAFETY MANAGEMENT 
Mothers will be observed for fatigue and encouraged to tell the research team that they are too tired 
to continue. In such cases, the data collection session will be terminated and a follow-up session 
scheduled. Our preliminary and ongoing studies have shown that some mothers may not read well and 
become fatigued. Questionnaires are written clearly and simply and have been tested with mothers 
with limited literacy. Questionnaires will be read orally to all mothers if they wish. Visual aides in the 
form of printed response sets will be given to mothers so that they can point to the desired responses.   
 

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Plans to ensure necessary intervention in emotional distress:  Research staff will follow a protocol for 
emergency situations and the project will adhere to the state legal statutes governing mandated 
reporting of suspected child abuse. If, during any contact with a project staff member, a mother 
expresses suicidal ideation, or is so immobilized by symptoms that she or her child are in danger, or is 
in danger because of domestic violence, the research staff member will assess the mother, contact the 
PI’s and Project Coordinator, and, if with the mother, will remain with her until a safe resolution has 
been reached, i.e., immediate referral to a community resource and/or involvement of supporters who 
can continue to ascertain the safety of the mother and infant/toddler after the team member leaves 
the premises.   
 
The decision about which resources to refer the mother will be made in consultation with the PI’s and 
Co-Investigator Meltzer-Brody, a psychiatrist specializing in women’s mood disorders and with the 
mother’s permission, the CDSA Service Coordinator. The project will maintain a log of all incidents 
requiring emergency, immediate response, or referral, and will report exceptional incidents to the IRB 
as appropriate. Dr.  Beeber, Dr. Wheeler, Dr. LaForett, the Project Coordinator (Salomon) and Dr. 
Meltzer-Brody are licensed mental health professionals familiar with depressive symptoms and 
emergency situations. The protocol will ensure that one or more of these research team members is on 
call for such situations. At the last contact with the study, mothers will receive a mental health 
resource referral list and with their permission, the CDSA Service Coordinator will be consulted as well 
to assure continuity. A review of all mothers actively in the project will be conducted in weekly 
research team meetings with the PI’s and when needed, Dr. Meltzer-Brody.   
 
10. DATA COLLECTION AND MANAGMENT  
Mothers will be told that all data will be separated from the consent forms and identified by a number 
and that only the research team will have access to the names and numbers. The identity of 
participants will not be divulged to anyone except in the instance that the mother cannot be located 
through the contacts she has provided. In that instance, Durham CDSA will be contacted for 
information about the mother’s current location and mothers will give the project written permission 
for this exception as part of their study consent. Permission to Contact forms will be kept in a locked 
file in a locked office at the Durham CDSA program until retrieved by a research team member. All 
study data will be kept in a locked office and a locked file at the FPG office. Data management 
procedures will include initial data cleaning, double keying, error checking and error corrections, and 
data validation prior to analysis. Data will be reported in aggregate form only, without identifying 
information by individual or site. All personnel will be trained to maintain security and confidentiality 
of the data. The mothers will be apprised of these precautions. 
 
11. RECRUITMENT STRATEGY 
Interest letters describing the study will be mailed from our Part C research partner to mothers in April 
-June 2018. Interested mothers will contact the research team by phone or email to schedule a time to 
screen them for eligibility for the study. Screenings will be done via phone by a research team member 
who will administer the PHQ-9 and collect demographic information. Researchers will give mothers 
opportunities to ask questions about the nature of their participation. If mothers speak Spanish, 

Intervention protocol template_Draft_29AUG2016 
 
materials will be available in Spanish and the screening process will be completed by a research team 
member who is bilingual in English and Spanish. 
 
Although our original inclusion criteria included individuals with a PHQ-9 score greater than 8, we were 
not able to include recruit enough mothers who met this criterion, so we dropped it from our eligibility 
criteria. 
 
12. CONSENT PROCESS 
For eligible mothers, researchers will schedule a home visit to go over enrollment procedures (i.e., 
complete consent forms). Researchers will give mothers opportunities to ask questions about the 
nature of their participation. If mothers speak Spanish, materials will be available in Spanish and the 
consent process will be completed by a research team member who is bilingual in English and Spanish. 
 
13. PLANS FOR PUBLICATION 
We have two papers in progress we will submit for publication. 
 
14. REFERENCES  
 
Caskey, M., Stephens, B., Tucker, R., & Vohr, B. (2014). Adult talk in the NICU with preterm infants and 
developmental outcomes. Pediatrics, 133(3), e578-e584. 
Caskey, M., & Vohr, B. (2013). Assessing language and language environment of high‐risk infants and children: a 
new approach. Acta Paediatrica, 102(5), 451-461. 
Gilkerson, J., Richards, J.A. (2008). The LENA natural language study. Boulder, CO: LENA Foundation. Retrieved 
from: https://www.lena.org/wp-content/uploads/2016/07/LTR-02-2_Natural_Language_Study.pdf 
Gilmore, L. & Cuskelly, M. (2008). Factor structure of the parenting sense of competence scale using a normative 
sample. Child: Care, Health, and Development, 35(1), 48-55. 
Irvin, D.W., Hume, K., Boyd, B.A., McBee, M.T., & Odom, S.L. (2013). Child and classroom characteristics 
associated with the adult language provided to preschoolers with autism spectrum disorder. Research in Autism 
Spectrum Disorders, 7(8), 947-955. 
Kronenke, K., Spitzer, R.L., & Williams, J. B. (2001).  The PHQ-9: validity of a brief depression severity measure.  
Journal of General Internal Medicine, 16(9), 606-613. 
Spitzer, R.L., Kroenke, K., Williams, J.B., & Lowe, B. (2006).  A brief measure for assessing generalized anxiety dis  
Suskind, D., Leffel, K.R., Hernandez, M.W., et al. (2013). An exploratory study of "quantitative linguistic 
feedback": Effect of LENA feedback on adult language production. Communication Disorders Quarterly, 34(4), 
199-209.order:  The GAD-7.  Archives of Internal Medicine, 166(10), 1092-1097. 

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Thiemann-Bourque, K.S., Warren, S.F., Brady, N., Gilkerson, J., & Richards, J.A. (2014). Vocal interaction between 
children with down syndrome and their parents. American Journal of Speech-Language Pathology, 23(3), 474-
485. 
Weisleder, A., Fernald, A. (2013). Talking to children matters early language experience strengthens processing 
and builds vocabulary. Psychological Science, 24, 2143-2152. 
Xu, D., Yapanel, U. & Gray, S. (2009).  Reliability of the LENA ™ Language Environment Analysis System in Young 
children’s Natural Home Environment.  Boulder, CO: LENA Foundation. Retrieved from: 
https://www.lena.org/wp-content/uploads/2016/07/LTR-05-2_Reliability.pdf  
Yoder, P.J., Oller, D.K., Richards, J.A., Gray, S., & Gilkerson, J. (2013). Stability and validity of an automated 
measure of vocal development from day‐long samples in children with and without autism spectrum disorder. 
Autism Research, 6(2), 103-107. 
15      APPENDIX 
 
Nothing to report.