Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical Maltreatment in a Selected Population
Phase: NA
Conditions: Parenting, Child Behavior, Child Rearing
Sponsor: Tulane University

 
Cover Page 
 
Study Protocol 
Study Title: Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child Physical 
Maltreatment 
Identifier: NCT04059185 
Document date: 08/16/2022 
 
 

 
Study Title:  Longitudinal Follow-up of Brief Parenting Interventions to Reduce Risk of Child 
Physical Maltreatment 
1. Study aim, background, and design 
 
Background 
Child maltreatment is a major public health problem with over 6 million children involved in 3.4 
million referrals to Child Protective Services and over 600,000 substantiated cases in the US annually 1. 
Child physical abuse threatens physical, mental, and behavioral health as well as epigenetic, brain, and 
physiological development in children.2-4 Some of the most effective, evidence-based interventions we 
have for preventing child maltreatment to date are home visitation programs 5. However, such 
programs are aimed at narrowly selected, high-risk target populations. They also are high-resource 
intensive and might not be appropriate or feasible for universal implementation. Yet interventions 
designed for broader segments of the population might have larger benefits for society as a whole, 
even when producing smaller reductions in risk 6. Such interventions can target highly prevalent norms 
in a population that raise risk for child physical abuse, such as use of physical discipline and other 
harsh parenting strategies. In doing so, such interventions may lower rates of abuse and other poor 
outcomes for children linked with poor parenting and childhood stress 7,8. There is a need to test such 
parenting interventions that are relatively low-cost, low-resource intensive, and adaptable to larger and 
more universal target populations, such as Special Supplemental Nutrition Program for Women, Infants 
and Children (WIC) and pediatric clinics, for the prevention and reduction of child abuse and violence in 
general.9-11  
Objectives and Specific Aims Our long-term goal is to enlarge the evidence base for low resource-
intensive and widely adaptable interventions that effectively target parenting outcomes to reduce risk of 
child physical abuse in settings with broad reach, such those serving WIC and other pediatric 
populations. The objective of this study is to test the effectiveness of two such interventions in 
promoting effective parenting and reducing child physical abuse risk as compared with “usual care” 
parenting education. The central hypothesis is that each of two brief interventions, Triple P-L2 and Play 
Nicely, will be more effective in improving parenting effectiveness and reducing child behavioral and 
emotional problems than the “usual care” condition. Full scale Triple-P is an evidence-based, five-level 
system of interventions shown to reduce risk for child maltreatment when all 5 levels are implemented 
12. However, implementation of a single level would be much less costly, more easily disseminated, and 
might in itself reduce risk in a broader population. Play Nicely is a brief computer-based intervention 
that has shown preliminary evidence for shifting attitudes about use of physical discipline when 
implemented in a pediatric primary care setting 13,14. However, it has yet to be tested within a large RCT 
or in a WIC population. The rationale for this study is to be able to inform policy for parent service or 
clinic centers serving high-volumes of parents that are interested in adopting relatively low-resource 
intensive interventions in order to reduce risk of child physical abuse and improve child health and 
development trajectories. We plan to test our central hypothesis by pursuing the following specific aims: 
(1) Test brief clinic-based interventions (Triple P-L2 and Play Nicely) aimed at addressing 
parenting effectiveness in managing difficult child behavior in a selected population of 
families. Our working hypothesis is that parent and child outcomes will be improved in each 
of these conditions compared to the control condition.  
(2) To establish sustained effects of brief parenting interventions on both parenting 
behaviors and child outcomes. Our working hypothesis is that parent and child outcomes 
will be improved (e.g., reduced parental use of CP and reduced child emotional and 
behavioral maladjustment) in both intervention conditions compared to controls at long term 
follow-up. In addition, when compared to controls, children and parents randomized to either 
intervention will exhibit better physiologic responses when playing or talking together. 
(3) Determine if intervention effectiveness is modified by parents’ perceived norms. Our working 
hypothesis is that stronger perceived injunctive norms by parents of professionals (e.g., 

 
pediatricians, mental health, and religious) supportive of physical discipline will be 
associated with reduced intervention effectiveness. 
(4) To establish the sustained effects of two brief parenting interventions on perceived 
injunctive norms about CP and support for CP use. Our working hypothesis is that 
parents will have and perceive less support for CP use (including amongst professionals 
trusted for parenting advice) in both intervention conditions compared to the control 
condition at long-term follow-up. 
 
Study Design 
This is a community-based randomized controlled trial. Parents (n=1200) with children 2 to 7 
years of age will be recruited from local WIC clinics and by open recruitment. Once consented, they will 
be enrolled, a baseline interview will be conducted, and they will be randomly assigned to one of 3 
conditions: (1) Triple P-Level 2 only (L2) intervention, (2) Play Nicely intervention, or (3) a “usual care” 
control group.  Three months later, a follow-up interview will be conducted in order to test for 
intervention effects. 1 year later, a follow-up interview will be conducted. Due to funding restraints, all 
participants may not receive a 1 year follow-up. In addition, a long term follow-up will be conducted to 
test sustained effects of the intervention. Participants’ children (n=1200) will be enrolled for the long 
term follow-up. Children will be invited to participate in order for the adult participant to be observed 
interacting with the child in several very benign behavioral activities. Adult participants that do not want 
to enroll their child may participate in the long term follow-up survey which they will have previously 
consented to. These low-resource intensive parenting interventions are expected to shift parenting 
attitudes, self-efficacy, and behaviors linked with child physical abuse risk. Even small reductions in 
such risk across large selected or universal target populations can result in large benefits to the whole 
population (i.e., Prevention Paradox 15). Lowered rates of problematic parenting practices will lead to 
improved child development and behavior. Further, by contributing to a reduction in cumulative adverse 
childhood experiences, these interventions also are expected to contribute to a long-term reduction in 
health disparities and risk for major public health problems such as smoking, obesity, drug abuse, risky 
sexual behavior, mental health disorders, and heart disease among others 3,4,16-23. 
     Our study name for presentation in the local community is “Tulane Innovations in Positive 
Parenting Study” (TIPPS). 
2. Subject Population 
 
We will recruit a total number of 2400 participants for this study. We will recruit 1200 adult participants 
from City of New Orleans and Jefferson Parish WIC Clinics and by open recruitment. Open recruitment 
will allow eligible moms to participate regardless of whether they hear about the study at WIC or from 
other sources, such as current participants or TIPPS community partners. Our planned recruitment sites 
are the New Orleans East, Central City, Algiers, and Crescent City WIC clinics. Our eligibility criteria 
include women who are (1) English-speaking, (2) adults, age 18 or older, (3) the parent of at least one 
child between 2 and 7 years of age (4) the primary caregiver of that child (5) able to return to a TIPPS 
study site in approximately 3 months for a follow-up appointment, and (6) available for up to 2 hours on 
date of recruitment to complete the baseline visit. Pregnant women meeting the above-mentioned criteria 
will not be excluded. During the long-term follow-up visit, one child for each adult with be enrolled 
(n=1200).  
 
3. Procedure 
 
Recruitment: For all recruitment at the WIC clinics, parents will arrive at the WIC clinic for their 
regularly scheduled WIC visit. Recruitment will begin in WIC clinic waiting rooms, at which time a TIPPS 
Team Member (Program Manager, Research Coordinator, Research Assistant, or Triple P Specialist) will 
tell the parent Tulane University is conducting a study on positive parenting and provide a brief description 

 
of the study. If the parent is interested in learning more, the TIPPS Staff Member will then assess the 
parent’s eligibility status. If the parent is eligible and interested, the TIPPS Staff Member will then confirm 
that she has completed all necessary WIC documentation and that she is scheduled for a follow-up 
appointment with WIC before moving forward with consent and enrollment. This allows WIC staff to 
complete the necessary data entry for the appointment and ensures that the parent’s time with us does 
not interrupt WIC’s appointment process. Once the TIPPS Staff Member confirms that WIC 
documentation is complete and has been returned to WIC’s intake staff, our staff will notify WIC staff that 
the parent is beginning their TIPPS Baseline appointment.  Basic screening of potential participants will 
be tracked using a recruitment tracking form (i.e., number of persons screened, eligibility status, declines, 
and enrollment status). 
WIC clients may also learn about the study before they arrive at WIC for their regularly scheduled 
appointments (i.e. before we would typically recruit them, per the above). WIC has offered and kindly 
agreed to mail a TIPPS recruitment flyer to WIC Clients’ homes along with WIC’s appointment reminder 
packets.  This new “mailer flyer” presents basic study information and informs interested individuals how 
to contact our TIPPS staff. At the time they call, a TIPPS Research Coordinator will confirm the 
individual's eligibility and request that she alert WIC staff of her intention to enroll in TIPPS when she 
arrives for her WIC appointment.  
For open recruitment, anyone that learns about the study via another source will contact TIPPS and 
schedule an appointment at a study site. 
 
Consent and Enrollment: A TIPPS Team Member will then take the parent through the informed 
consent process utilizing the Updated Informed Consent – New Participant form. This will include 
providing a copy of the consent form to the parent, reviewing the content of the consent form with the 
parent, answering any questions she might have, and, if she agrees to participate, having her initial 
each page and sign and date the final page. Our staff will also sign and date the final page. Our staff 
will then administer a comprehensive Contact Information Form.  Once this is complete, our staff will 
assign a participant ID and perform random group assignment. The Team Member conducting the 
baseline interview will remain blinded to the group assignment until the interview is complete.  
Baseline Interview: A TIPPS Team Member will then conduct the Baseline interview. Participant 
responses will be entered by the interviewer into the computer and saved on a secure server via 
REDCAP.  (If WiFi is not available for any reason, the interviewer will provide a paper copy of the 
survey to the participant and will administer the questionnaire using the paper copy. The paper copy will 
be kept secure and confidential until the responses can be entered and saved on REDCap.) Response 
Cards may be provided so that participants can see as well as hear the response options. Whenever 
possible, our staff will offer childcare in order to minimize distractions. Water and snacks (e.g., pretzels, 
goldfish) may be offered to participants or their children when available. A series of sensitive questions 
(Maternal Adverse Childhood Experiences; Hits, Insults, Threatens and Screams; Alcohol Use) will be 
answered by the participant privately on a paper copy of the survey in order to maximize participant 
confidentiality and reduce social desirability bias. If an individual indicates suicidal ideation, either by 
answering affirmatively (i.e. 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely) to “Thoughts of 
ending your life” in the Brief Symptom Inventory or by mentioning experiencing suicidal feelings or 
contemplating suicide at any other time during the interview, the Staff Member will follow the Suicide 
Risk Protocol to connect the participant with the appropriate type of resources.  
Once the Baseline Interview is complete (approximately 45 minutes), the participant will be 
informed of their random assignment to one of three conditions: (1) Triple P-Level 2, (2) Play Nicely, or 
(3) Control. The next procedure will then depend upon which of the three groups the person is assigned 
to as follows:   
Intervention Procedures:   
(1) Triple P-Level 2: The Triple P Specialist will conduct this intervention. This intervention will take 

 
no more than 60 minutes and childcare will be provided when available to minimize distractions. When 
the intervention is complete, the Triple P Specialist will complete an “Intervention Fidelity Checklist” to 
confirm some key aspects of the intervention such as: length of consultation, positive parenting booklet 
provided, whether or not and which parenting tip sheet(s) were provided. The Triple P Specialist will 
also schedule an appointment to call the participant within the next two weeks for a follow-up consult to 
assist and support the parent as needed with their consultation. 
(2) Play Nicely: If assigned to Play Nicely, a TIPPS Team Member will escort the participant to a 
room where this intervention module will be completed on a computer. The Team Member will 
introduce the program and provide headphones and childcare when available to minimize distractions. 
This intervention will take approximately 30 minutes. The participant will be instructed to notify the 
Team Member once they have finished viewing the program. The Team Member will conduct an 
“Intervention Fidelity Checklist” to confirm some key aspects of the intervention such as: length of time 
spent on the module, number of discipline options selected, and which discipline options they are most 
likely to use or not use.  The Team Member will then provide a “Play Nicely Strategies” handout.”. 
(3) Control: If assigned to the control group, a TIPPS Team Member will give the participant the 
“control” WIC Resource Guide and record that this was done. This Resource Guide will be the “Health 
Care and Social Service Programs You May Qualify For” pamphlet currently provided to all families in 
the Louisiana WIC Program.24 
 
 
Debrief: Once both the Baseline Interview and the Intervention phase are complete, a TIPPS Team 
Member will schedule the 3-month Follow-Up Appointment, provide the control condition (WIC’s 
pamphlet entitled “Health Care and Social Service Programs You May Qualify For”), provide an area-
specific resource guide, provide a children’s book partially donated by the New Orleans Public Library 
Foundation (NOPLF) as long as supplies last, and give the participant our incentive (a $25 gift card). 
The whole procedure (enrollment, baseline interview, intervention, and debrief) is expected to take no 
more than 2 hours.  
 
Prior to 3-Month Follow-up: We will make every effort to maximize retention in our study at this 3-
month follow-up visit. Participants will receive appointment reminders according to modes of contact 
they described as most preferable in the Contact Information Form. Reminder postcards will be sent to 
mailing addresses provided in the Contact Information Form. Approximately one week before the 
scheduled 3-month Follow-Up visit, our team will work with WIC staff to note any modifications to the 
planned appointment dates and times.   
3-Month Follow-Up Visit: If the participant has a WIC appointment, when they return to WIC for 
their 3-month visit and once they’ve completed their WIC documentation, a TIPPS Team Member will 
conduct the 3-month interview with them. This interview should take no more than 45 minutes. As with 
the baseline visit, childcare will be offered when available and the Suicide Risk Protocol will be followed 
if needed. Once the interview is completed, a TIPPS Team Member will give the participant a $25 gift 
card, for a total of $50 for completing both baseline and 3 month interviews. In the event that the 
participant cannot return to the study site for their 3-month visit, the TIPPS team member will schedule 
the 3-Month interview as a phone interview. If the participant is unwilling or unable to complete the 
follow–up interview over the phone, a follow-up interview will be scheduled at a more convenient 
location for the participant, such as a local business or the participant’s home. The participant will be 
mailed a $25 gift card to the address she has provided after the phone interview is complete.  
If the participant has not yet consented to the revised Updated Baseline Consent – Current Participants 
form, which is dependent upon the date of their enrollment, the TIPPS staff member will review the 
updated form with the participant. The TIPPS staff member will highlight the additions to the informed 
consent with the participant, which include Consent for Future Contact and consent to additional 
interviews, including a one Year Follow-Up interview. For in-person visits, this will include providing a 

 
copy of the consent form to the participant, reviewing the content of the consent form with the parent, 
answering any questions she might have, and, if she agrees to participate, having her initial each page 
and sign and date the final page. Our staff will also sign and date the final page. For telephone 
interviews, this will include reviewing the oral consent script before beginning the interview, answering 
any questions she might have, and, recording written documentation if she agrees to participate. The 
Updated Baseline Consent Form ensures all participants are presented with the opportunity to 
participate in future TIPPS interviews, as well as be contacted to participate in future research. Parents 
that express interest in additional parenting advice or services will be given a Resource Guide and, if 
needed, provided with a referral to the Children’s Bureau for additional help and guidance.  
It is common for as many as 50% of WIC participants to miss their scheduled WIC visits. If a participant 
misses her 3-month follow-up visit for our study, our team will contact the participant and try to 
reschedule the visit.  We will continue trying to reschedule and complete this visit for up to 6 months.  If 
the participant has moved or is otherwise unable to return to WIC, but is willing to complete the 
interview via phone, we will do so. After 6 months post baseline, if no follow-up data is obtained, we will 
code the participant as “lost to follow-up.”   
Despite our best efforts to retain all of our study participants, we anticipate a 75% retention rate.  In 
other words, we expect that at least 25% of our baseline sample (n=1200) will not return to provide 
follow-up data.  Hence, we expect our final 3-month sample to include 900 participants. 
Data Security:  Data will be stored on Tulane’s secure REDCAP server. Only the PI, CoIs, and the 
Program Manager will be able to download the data onto their own computers for data analysis.  All 
computers are password protected. 
Due to grant funding limits, not all participants may be able to participate in a 1-Year Follow Up. 
The protocol below is for those participants who are scheduled to complete their 1-Year Follow-
Up before grant funding for TIPPS is complete. 
    Prior to 1 Year Follow-Up Visit: Our team will contact participants to schedule a 1-Year Follow Up 
interview starting up to eleven months after participants have completed their Baseline Interview. Only 
participants who have who have completed their 3-Month Follow-Up Visit as well as signed the Consent 
to Future Contact or Updated Consent Form will be contacted. A TIPPS Team member will contact the 
participant according to modes of contact they indicated as most preferable in the Contact Information 
Form. Interviews will be scheduled either in person at the study site, in person at a location that is more 
convenient for the participant, or over the telephone. Interviews conducted over the telephone will be 
offered to participants who have moved out of the area, or when their schedule does not allow them to 
attend an interview at the WIC office during available TIPPS appointment times. After an appointment 
date and time has been set, participants will receive appointment reminders a week before the 
appointment according to modes of contact they described as most preferable in the Contact 
Information Form. 
1-Year Follow-Up Visit: A TIPPS Team Member will conduct the 1-year Follow Up interview with the 
participant either over the phone or in-person at the WIC clinic. In the event that the participant cannot 
or is unwilling to return to the study site for their 1-Year Follow Up visit, the TIPPS team member will 
schedule the 1- Year interview as a phone interview. If the participant is unwilling or unable to complete 
the follow–up interview over the phone, a follow-up interview will be scheduled at a more convenient 
location for the participant, such as a local business or the participant’s home. The interview should 
take no more than 45 minutes. As with the baseline and 3- month visit, childcare will be offered when 
available and the Suicide Risk Protocol will be followed if needed. Once the interview is completed, a 
TIPPS Team Member will provide the participant with comparable compensation to previous interviews, 
either in person or mailed to the address provided.  

 
If the participant has not yet consented to the revised Updated Baseline Consent – Current Participants 
form, which is dependent upon the date of their enrollment, the TIPPS staff member will review the 
updated form with the participant. The TIPPS staff member will highlight the additions to the informed 
consent with the participant, which include Consent for Future Contact and consent to additional 
interviews, including a one Year Follow-Up interview. For in-person visits, this will include providing a 
copy of the consent form to the participant, reviewing the content of the consent form with the parent, 
answering any questions she might have, and, if she agrees to participate, having her initial each page 
and sign and date the final page. Our staff will also sign and date the final page. For telephone 
interviews, this will include reviewing the oral consent script before beginning the interview, answering 
any questions she might have, and, recording written documentation if she agrees to participate.  The 
Updated Baseline Consent Form ensures all participants are presented with the opportunity to 
participate in future TIPPS interviews, as well as be contacted to participate in future research. Parents 
that express interest in additional parenting advice or services will be given a Resource Guide and, if 
needed, provided with a referral to the Children’s Bureau for additional help and guidance.  
If a participant misses her 1 year follow-up visit for our study, our team will contact the participant and 
try to reschedule the visit. We will continue trying to reschedule and complete this visit for up to 6 
months.  If the participant has moved or is otherwise unable to return to the study site, but is willing to 
complete the interview via phone, we will do so. After 1 year and 6 months post baseline, if no follow-up 
data is obtained, we will code the participant as “lost to follow-up.”   
Prior to Long Term Follow-Up Visit: Our team will contact participants to schedule a Long Term 
Follow Up interview starting at least twenty-three months after participants have completed their 
Baseline Interview. In order to be eligible to participate in the long term follow up assessment, a 
participant must have completed the baseline assessment, and also must have ongoing frequent 
interactions with the index child as assessed by a screener question. If participant has not signed the 
Consent to Future Contact and/or Updated Consent Form, our team will contact participant via phone to 
obtain oral consent to future contact or via mail to obtain written consent to future contact before 
scheduling a Long Term Follow up interview. Mailed consent forms will include information on current 
and ongoing opportunities to participate in the study, and similar information will be relayed over the 
phone when attempting to obtain oral consent to future contact. A TIPPS Team member will contact the 
participant according to modes of contact they indicated as most preferable in the Contact Information 
Form.  
In order to improve our participant retention rate, we are introducing a few additional methods for 
reconnecting with our participants.   
First, if attempts to contact the participant using primary contact information fail, and the participant has 
indicated a secondary contact person, the secondary contact will be offered a $10 incentive payment if 
we are able to successfully reach the participant and the participant goes on to complete the long term 
follow up visit.  
Second, if we are unable to reach the participant through provided contact information (for example, if 
the number is no longer working, or the mail was returned), a member of the study team may confirm or 
update the participant’s given contact information using a publicly available registry. This supports the 
integrity of the study by ensuring that to the extent possible, all participants are offered an opportunity 
to participate in long term follow up.    
Third, our study partners may send a message to their own client lists with contact information for the 
TIPPS study, so any of these clients that were previously enrolled in the study that we have not been 
able to reach through other means will be aware that follow up opportunities for participation are 
available.  

 
When contacted, participants will be notified about the new follow-up, which includes enrolling their 
child. Participants will be told that there are new follow-up activities similar to what they might do at a 
doctor visit as well as a few activities that involve interacting with their child. They will be told that when 
they arrive for the appointment the full procedures will be explained and a new consent form will be 
signed at the in person visit to indicate participant consent and parental permission. Participants will 
have all questions answered during this call and the follow-up visit. If the participant is interested in 
engaging in the long-term follow up assessment, they will be screened for eligibility before scheduling. 
Participants may decline participation in any portion of the follow-up visit and still be part of the study.  
Follow-up Visits will be scheduled in person at the Tulane University School of Medicine, or the survey 
portion of the visit may be completed remotely by phone or by zoom if the participant is unable to attend 
in person. After an appointment date and time has been set, participants will receive appointment 
reminders a week before the appointment according to modes of contact they described as most 
preferable in the Contact Information Form.  
Long Term Follow-Up Visit: Participants will arrive at the research site with their index child, the child 
indicated in the baseline survey as being age 2-7. Children participating in the follow-up will be ages 4-
15. A trained research team member will conduct the informed consent procedures followed at the 
baseline visit. If the adult participate does not want her child to participate, she may complete the long-
term follow-up survey which she has consented to previously. If she agrees to participate and gives 
permission for her child to participate, she must review and sign a new consent form before 
participating in any Long Term Follow-Up activities. The informed consent form will be a record of the 
mother’s agreement for both her and her child to participate. Additionally, each child between the ages 
of 7-15 must provide assent. The informed consent process and the informed assent process will 
include: providing a copy of the consent form to the participant, reviewing the content of the form, 
answering any questions they might have, and, if they agree to participate, having them initial each 
page and sign and date the final page. The participant will also initial as to whether or not they consent 
to being recorded and whether or not they consent to have video recordings stored for future studies 
after the close of the study, all of which will be tracked in the REDCap database and used to guide data 
collection, video storage procedures and data cleaning and analysis. Our staff will also sign and date 
the final page. If the survey is conducted remotely, the child will not participate, the informed consent 
process will be completed with the adult only using the oral consent script, and no video recordings will 
be created. The participant will be asked whether or not they consent for the phone interview to be 
recorded for quality assurance purposes, and that will be recorded in the oral consent form as well as in 
the participant’s record in the REDCap database. 
 
Upon completion of the informed consent process, a research assistant will conduct the Long Term 
Follow-Up interview with the adult participant. The interview should take no more than 45 minutes, or 
up to 90 minutes remotely due to inherent communication delays. Once the interview is completed, a 
TIPPS Team Member will distribute the Child Behavioral Checklist to the caregiver to complete on 
paper, orally if remotely, or it can be completed either previous to the visit or after the survey using an 
electronic delivery format. This will be the end of the visit if conducted remotely, and the participant will 
be given a $50 gift card incentive for their time. For participants completing the survey by phone, the 
following portion of the visit described below, consisting of observational activities done in the clinic, 
can be scheduled and completed at a later date, if and when feasible. If the observational activities are 
scheduled at a later date due to Coronavirus precautions or safety concerns, a subsection of this 
survey will be repeated at the beginning of that visit, which relates specifically to the impacts of the 
pandemic and will take approximately 10-15 minutes. As with the baseline and 3- month visit, childcare 
will be offered when available for additional children and the Suicide Risk Protocol will be followed if 
needed. Additionally, if the participant indicates that their child is undergoing a period of crisis or trauma 
and would like additional resources, she will be offered a referral to Children’s Bureau of New Orleans 

 
(CBNO) Crisis response unit. If desired, the participant can grant us permission to release her contact 
information to CBNO; this permission will be indicated on the CBNO referral form. If this permission is 
provided, we will send this release form via encrypted email to the CBNO crisis team, and their team 
will then contact the participant directly. Water and snacks (e.g., pretzels, goldfish) may be offered to 
participants or their children when available with caregiver approval. 
A separate research assistant will engage the child participant in several tasks. The first task will be the 
Marshmallow Test, an inhibitory control task where the child is told to wait for 1 minute to eat a 
marshmallow, and if they are able to wait, they will get two marshmallows. The time before the child 
eats the marshmallow is a validated measure of inhibitory control; inhibitory control has been found to 
be a significant predictor of child health and development outcomes across the life course. Cognitive 
flexibility and executive function will also be measured using the NIH toolbox, administered by tablet. 
This will be operationalized by several tasks from cognitive domain of the NIH toolbox to assess 
executive function, working memory, inhibitory control and cognitive flexibility described in in the table 
below.10 The NIH toolbox is a valid and reliable instrument shown to be appropriate for ages 3-85 years 
old. 
 
Following the surveys, ECG data will be collected on the child and mother concurrently, acquired using 
Mindware Technologies mobile recorders, and transmitted via wireless signals to a computer monitored 
by a research assistant. The ECG signals will also be synchronized with video recordings using 
Mindware Biolab technology. A research team member will attach soft, mildly adhesive stickers to the 
child and mother; the plastic lead wires for the measurement will be placed under clothes for comfort 
and safety. The child’s leads will always be attached by a trained research assistant with the mother 
present. After participant and child leads have been connected to ECG machines, the participant and 
child will do 3 very benign behavioral activities together: 1) watch a short video, 2) tell a story together, 
and  3) engage in a cooperative task (drawing with an Etch A Sketch). Interactions will be video 
recorded with parental consent and child assent and coding of parent and child behaviors will be done 
using the Coding Interactive Behavior (CIB) codes that have been internationally validated. ECG data 
will then be processed offline using Mindware software; research assistants will visually inspect the 
data for missing heartbeats, as well as for erroneously identified peaks, which will be manually deleted 
or inserted as appropriate. The software will also give estimates of respiration and cardiac activity. 
Respiratory Sinus Arrhythmia (RSA) values will be processed in 30-second epochs across tasks for 
mothers and for children, and multilevel growth models will be built examining each 30-second epoch 
over the course of the task, relative to the individuals’ baseline RSA. Dr. Drury will have full oversight of 
the dyadic coding of video recorded interactions between mother and child. Lastly, a TIPPS Team 
Member will provide the participant with locally-based health care resources and a gift card to thank her 
for her time. If the participant completes both the survey and observational activities in the clinic in one 
visit, she will receive in total a $125 gift card. If she has previously completed the survey by phone, she 
will receive a $75 gift card for completing the observational activities in the clinic. Also, after the survey 
is administered by phone, or otherwise after the clinic visit, the participant may be provided with 
directions to take an optional, anonymous participant satisfaction survey. Further, participants may be 
offered an opportunity to stay engaged with the study as we pursue efforts to share results with the 
community. 
 
If a participant misses her Long Term Follow-Up visit for our study, our team will contact the participant 
and try to reschedule the visit. We will continue trying to reschedule and complete this visit for the 
remainder of the funded data collection period. If a participant indicates they no longer want to be 
contacted, we will discontinue contact with them immediately. Data Security:  Data will be stored on 
Tulane’s secure REDCAP server.  Only the PI, Co-Is, and the Program Manager will be able to 
download the data onto their own computers for data analysis. All computers are password protected.  

 
Community Advisory Board: A community advisory board (CAB) will be formed to achieve three 
goals: 1) Improve our internal processes to maximize participant engagement, retention and 
satisfaction by seeking feedback from participants who have completed all data collection activities 
outlined in our IRB protocol in order to ensure culturally relevant and appropriate communication 
strategies and materials are being used within our study; 2) Optimize the dissemination of our study 
findings by gaining feedback about messaging content, format and mode of sharing results with our 
study population and other community audiences.; and 3)  Facilitate conversations about ways our 
study findings could be translated into action (e.g., policy change). 
CAB members may consist of community partners (e.g., NOHD personnel), parents or other interested 
persons in the community, and study participants who have completed all study procedures outlined in 
this study protocol. CAB activities might take many forms to obtain information from members in a way 
that is most feasible and preferable to them (e.g, individual or group conversations, which may take 
place over phone, zoom, or in-person).   
For goal #1, we plan to engage roughly 6 to 8 CAB members, drawing from participants who have 
completed all study activities outlined in the IRB protocol. Potential CAB members will be contacted via 
phone to discuss the opportunity to become a CAB member and to answer their questions based on a 
prepared script. 
4. Follow up 
If either intervention condition is found to be more effective than the control condition, these findings will 
be made available to the control group along with information about how they can access the effective 
intervention if they wish. This information will be made available to the study participants by email, 
phone, or snail mail dependent on contact information provided.      
5. Risks 
Loss of privacy is a possible risk; the subjects’ privacy will be protected by using subject ID numbers 
and keeping identifying information separate from the data. Once the data have been collected, only 
the research team will have access to the data via a secure server. Specifically, the contact information 
form, consent form, and “consent to future contact form” (if signed) will be stored in the participant 
folders, which will be stored in a locked cabinet in the Program Manager's office. Raw data will be 
entered directly and securely through data management software. Files and video recordings will be 
kept in locked cabinets in the Program Manager’s office and Dr. Drury’s laboratory. All information will 
be coded with a subject identification number and only Dr. Taylor, Dr. Drury, and the Program Manager 
will have access to the decoding information so that no study information will contain actual identifying 
information. Identifying information will not be used in publications or presentations.  
We may keep the data from the long term follow-up, including the video recordings with written consent, 
for purposes of the study for up to 5 years after the end of the study. We may also remove information 
that identifies the participant from the data and may keep and use the de-identified data. We will not 
use or share the data, even if identifying information is removed, for any research that is not part of the 
study unless we have contacted the participant and obtained written consent.  
Children may experience momentary discomfort during the removal of the adhesive ECG leads, much 
like the removal of a Band-Aid. A member of the research team will remove the adhesive leads, unless 
the mother feels that the child may be less uncomfortable if she removes them herself. The mother will 
be present at all times during the placement and removal of the adhesive leads. 
Parents that express an interest in additional parenting advice or services will be provided with a 
referral to the Children's Bureau for additional help and guidance. 

 
If subjects participate at WIC, the research will be conducted at the same time and place where 
subjects regularly obtain their WIC voucher so as to be convenient for the subjects. 
Participants always have the choice NOT to answer questions if they choose not to or have the ability 
to withdraw from the study at any time without penalty. 
As noted in our consent form, if the participant “indicates that your child is in danger of being seriously 
harmed, or you or your child are in danger of hurting someone, the research staff is required by law to 
report this information to the appropriate agency personnel.”  We have established a clear child abuse 
reporting protocol for our staff.  This protocol has been developed and reviewed in collaboration with 
Paulette Carter, Director of CBNO. 
Minimizing Risks and Monitoring Data: The investigators will ensure that proscribed confidentiality 
measures are followed and will provide extensive training to all staff to ensure that protocols are being 
followed. As part of their employment contract, all staff will be asked to sign a form stating that they will 
not breach any of the confidentiality protocols. All information will be coded with a subject identification 
number. Any identifying information collected will remain separate from study database and hard copies 
will be stored in locked cabinets in the PI's secure office and will be destroyed following study 
conclusion. Only aggregated data will be reported in the study results; no names or other identifying 
information will be reported.    
Subject code numbers for each child will be assigned at the time of consent and will be based on their 
mother’s ID number and will not include any other information.  
Materials generated under the project will be disseminated in accordance with University and funder 
policies. Publication of data shall occur during the project, if appropriate, or at the end of the project, 
consistent with normal scientific practices. Research data which documents, supports and validates 
research findings will be made available after the main findings from the final research data set have 
been accepted for publication. Such research data will be redacted to prevent the disclosure of 
personal identifiers.  
Computers that will be utilized during all phases of this proposal are password and software encrypted 
to prevent inappropriate access to information. All data will be stored in electronic format using 
password protection and encryption on the database. All unique identifiers will be protected as 
described above. 
6. Benefits 
There will be no direct benefits to subjects for participating in this research, but the knowledge gained 
from the study may benefit society in general. Anticipated benefits might include a participant’s greater 
understanding of positive parenting techniques. 
7. Remuneration 
At the Baseline visit, a Team Member will pay the participant with a $25 gift card to a local retailer as 
recommended by our WIC partners before the participant leaves the site. Then, at the 3-month follow-
up visit to the study site, once the follow-up interview is completed, a Team Member will pay the 
participant with another $25 gift card, for a total of $50 in gift cards.  If the participant completes the 1-
year follow  interview, a Team Member will provide the participant with comparable remuneration to the 
first two interviews.  
Upon completion of the Long Term follow-up visit, a participant will receive a $50 gift card for 
completion of the Long Term follow-up survey if completed by phone, and a $75 gift card for completion 

 
of the in-clinic observational activities - if and when they are completed at a later date. Alternatively, if 
the participant completes both components of the visit at the same time in the clinic, they will receive a 
$125 gift card.  
8. Academic or Extra Credit 
N/A 
9. Costs 
There will be no costs to the subject for participating in this research study. 
10. Alternatives 
 
Subjects always have the option to not participate in the research. 
 
11. Consent process and documentation 
 
The informed consent process will include providing a copy of the consent form to the parent, reviewing 
the content of the consent form with the parent, answering any questions she might have, and, if she 
agrees to participate, having her initial each page and sign and date the final page of the consent form. 
On the long term follow-up consent form, the participant will also initial as to whether or not they consent 
to being recorded and whether or note they consent to have video recordings stored for future studies 
after the close of the study, all of which will be tracked in the REDCap database and used to guide data 
collection, video storage procedures and data cleaning and analysis. Our staff will also sign and date the 
final page. Once the parent has finished reading each page, the Team Member will review the content of 
the consent form and highlight particularly important points, namely: (1) their decision to participate is 
completely voluntary in nature and (2) does not affect their receipt of WIC services, (3) they will be 
randomly assigned to one of three groups, (4) they may withdraw or refuse to answer any questions at 
any time, and (5) their personal information will be kept confidential.  
 
The Team Member conducting the interview will remind the participant that all responses are optional, 
that she can choose to end her participation at any point and will ask the participant if she has any 
questions. This reminder will be reiterated before all follow-up surveys and throughout the course of all 
interviews. 
 
The reminder call made one week before the second scheduled meeting will be made using a script to 
prevent unintentional coercion.  
 
If a Follow-Up Survey is conducted via telephone, the team member will read the Oral Consent Script, 
receive oral consent from participant for additional interviews, and the team member will provide written 
documentation of consent.  
 
Because the compensation is a maximum of $75 per visit or study section, there is little possibility of 
coercion or undue influence. 
 
 
 
 
 
 
 

 
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