Parent Emotion Socialization and Child Emotion Regulation in FASD
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Sponsor: University of Rochester

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Parent Emotion Socialization and Child Emotion Regulation in FASD
Principal Investigator – Christie L. M. Petrenko
Mt. Hope Family Center, University of Rochester, 187 Edinburgh St., Rochester, NY 14608
1.
STUDY OVERVIEW – PURPOSE AND BACKGROUND
Children with fetal alcohol spectrum disorders (FASD) have high rates of mental health problems and 
incur physical and mental health expenditures that are 9 times higher than other children (Amendah, 
Gross, & Bertrand, 2011; O’Connor, 2014; Streissguth et al., 2004). These mental health problems 
contribute to poor social adjustment for children with FASD and result in considerable emotional and 
financial burden for families. Emotion regulation is a core area of impairment in FASD (Kable et al., 
2015) and is implicated in most mental health disorders (Zeman, Cassano, Perry-Parrish, & Stegall, 
2006). Research on empirically validated interventions for children with FASD is limited (Petrenko, 
2015). Results from two interventions targeting emotion regulation in FASD demonstrate that child-
focused interventions are insufficient to habilitate children’s emotion regulation to adaptive levels 
(Nash et al., 2014; Wells, Chasnoff, Schmidt, Telford, & Swartz, 2012). Research is needed to 
identify alternate targets for intervention (e.g., parent training, environmental modifications) to 
improve the emotion regulation difficulties of children with FASD. 
This study investigates a novel intervention target to improve the emotion regulation and adaptive 
functioning of children with FASD. Research with other populations provides ample evidence for the 
impact of parent emotion socialization on the development of child emotion regulation and other 
outcomes (e.g., Eisenberg, Cumberland, & Spinrad,1998; Katz, Maliken, & Stettler, 2012). In 
addition, studies demonstrate that parent emotion socialization is amendable to intervention and 
results in improved child and parent outcomes (e.g., Havighurst, Wilson, Harley, Prior, & Kehoe, 
2010). However, no studies have investigated the emotion socialization practices utilized by parents 
of children with FASD or whether interventions targeting parent emotion socialization result in 
improved child emotion regulation and behavior in this population. 
This study will address this critical gap by initiating an empirical test of a promising emotion-focused 
intervention, Tuning In To Kids (TIK; Havinghurst & Harley, 2007), with families raising children 
with FASD. Results from this initial efficacy trial will determine whether parent emotion 
socialization is a promising intervention target for this population. Consistent with a developmental 
psychopathology perspective (Toth, Petrenko, Gravener-Davis, & Handley, 2016), multi-level data 
from the efficacy trial will be leveraged to test theorized associations between parent emotion 
socialization and child emotion regulation and identify possible factors contributing to individual 
differences. These results will inform possible intervention adaptations for this population and 
provide the necessary foundation for larger-scale efficacy trials. The long-term goals of this research 
are to better understand the complex factors influencing emotion regulation in children with FASD 
and improve mental health interventions and outcomes for this population.
2.
CHARACTERISTICS OF THE RESEARCH POPULATION
2.1.
Subject Characteristics
Participants will include children (ages 4-12) with FASD who reside in some form of out-of-
home care (e.g., adoptive parent, relative, or legal guardian) and their primary caregiver. 
a)
Number of Subjects: Power analyses suggest a minimum sample size of 72 caregiver-
child dyads to detect medium effects or larger across study aims. We will aim to enroll up 
to 120 families to achieve a sample size of 72 dyads with adequate data at study timepoints 
and have sufficient power to detect effects. This sample size will account for families who 

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consent to the study but do not begin study visits and an expected 10% attrition of families 
randomized to treatment condition (based on our prior trials). In families with multiple 
caregivers, families will be asked to indicate the primary caregiver or the caregiver with 
whom the child spends the most time to complete research visits. In families with more 
than one child with FASD in the study age range, families will be asked to randomly 
choose the child that will participate in research visits.  
b)
Gender and Age of Subjects:  Children will be between age 4 and 12 years. Caregivers 
will all be over age 18. Participants will not be recruited or selected based on gender; 
participants will be both male and female. The proportion of female caregivers participating 
in research visits will likely be higher than for males, given that females are more likely to 
take on the role of primary caregiver. We aim to enroll approximately equal numbers of 
boys and girls with FASD in the study.
c)
Racial and Ethnic Origin: Participants will not be recruited or excluded from 
participation on the basis of race or ethnicity. Given that children with FASD will be in out-
of-home care, the rates of racial/ethnic backgrounds may differ between caregivers and 
children. Based on US census records for counties in the project catchment area, it is 
expected that samples may include 5% of families who report their ethnic identify as 
Hispanic. Racial breakdown is estimated as: 80% White/Caucasian, 15% Black/African 
American, 1% American Indian/Alaskan Native, 2% Asian, 0% Native Hawaiian/Other 
Pacific Islander, and 2% more than one race. Historical recruitment rates suggest children 
with FASD will have higher rates of Black/African American, American Indian/Alaskan 
Native, and more than one race. Racial estimates for children are: 64% White/Caucasian, 
21% Black/African American, 4% American Indian/Alaskan Native, 3% Asian, 0% Native 
Hawaiian/Other Pacific Islander, and 8% more than one race. 
d)
Vulnerable Subjects:  The inclusion of children with FASD is integral to the proposed 
research aimed at understanding the association between parent emotion socialization and 
child emotion regulation skills. Children between the ages of 4 and 12 were selected for 
this study as prior research with other populations documents the relevance of targeted 
constructs across this age span (e.g., Katz et al., 2012) and the TIK intervention is 
appropriate for families of preschoolers through preadolescents. Dr. Petrenko has 
considerable experience working with children with FASD and their families in both 
research and clinical settings. Clinical and research staff will be carefully selected and well 
trained to establish rapport and engage children and families, as well as handle sensitive 
and confidential information with care and respect for the participants who provide it. 
2.2.
Inclusion and Exclusion Criteria
a)
Inclusion Criteria:  Families will be eligible for the study if they:

Have a child between the age of 4 and 12 with a diagnosis of an FASD based on 
the Revised 2016 Hoyme criteria (Hoyme et al., 2016) or the DSM-5 criteria for 
Neurobehavioral Disorder Associated with Prenatal Alcohol Exposure (ND-PAE). 

The child is in some form of out of home care (e.g., adoptive, foster, relative, or 
other legal guardian)

The child has resided with the primary caregiver for at least a year and be expected 
to remain in that placement for at least 6 months (study duration).
FASD diagnostic records will be obtained for each child at study entry (from the child’s 
electronic medical record, from outside medical providers directly with appropriate release, 

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and/or directly from the parent) to confirm diagnosis and prenatal exposure history. The 
University of Rochester is currently the only specialty diagnostic clinic for FASD in New 
York State. Dr. Petrenko is one of the primary clinicians involved in diagnosis of FASD at 
URMC Developmental & Behavioral Pediatrics and has eRecord access as part of her role 
there. 
For children with a suspected FASD diagnosis who have not been formally evaluated yet, 
Dr. Petrenko will review existing records and can complete a brief diagnostic interview 
with the parent to determine if DSM-5 criteria for ND-PAE are met (see DSM-5 Diagnostic 
Criteria Checklist for ND-PAE). If met, children will be eligible to participate in this study. 
Children who meet criteria for ND-PAE will also be referred to the FASD Diagnostic 
Clinic at URMC for further medical diagnostic evaluation and treatment planning. When 
screening is inconclusive or additional information is needed to determine diagnosis (e.g., 
confirmation of alcohol exposure), children will be referred to the URMC FASD 
Diagnostic Clinic for further evaluation and will not be eligible for the study unless an 
FASD diagnosis is rendered at a later date. 
b)
Exclusion Criteria: 

A history of other genetic, neurological, or significant medical conditions, 
traumatic brain injury, serious psychiatric illness or disability that would preclude 
data collection

Child has a moderate to severe intellectual disability (IQ < 55)

Child or caregiver has insufficient proficiency in English

Caregiver is a biological parent of the child with FASD
3.
SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT
3.1.
Method Of Subject Identification And Recruitment
Recruitment of caregivers raising children with FASD will occur via provider referrals, an 
existing database of families who have consented to be contacted about future research 
(RSRB00055352), and presentations at parent support groups and conferences. 
The small number of providers who serve this population in the region will be informed about 
the study and can tell interested families to contact the research team to learn more. A study 
flyer and contact form will be provided to providers that they can give to interested families. 
The largest provider of diagnostic and intervention services for FASD in the area is 
Developmental and Behavioral Pediatrics (DBP) at URMC. Lynn Cole, MS PNP is the clinical 
director of this service and is in full support of this project. Ms. Cole co-directs a 
multidisciplinary FASD diagnostic with Dr. Petrenko. In addition, Ms. Cole and other 
developmental pediatricians regularly see children with FASD for initial diagnosis (especially 
children 6 and under) and medical follow-up. Ms. Cole, will inform families about the study 
and can provide them with the flyer and/or contact form. She has also agreed to send out a letter 
about the study to families of existing patients with FASD seen at DBP. 
When Dr. Petrenko informs families about the study during diagnostic evaluation feedback 
sessions or at parent support group meetings she runs, she will direct families to contact the 
study coordinator if they are interested to complete eligibility screening. Families will also have 
the option to complete a contact form for a research team member to call them. Potential 
coercion will be reduced by providing families information about all applicable services and 
supports available to them during interpretation sessions, as is standard practice.

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3.2.
Process of Consent
Upon receiving the appropriate name release or being contacted by interested families, research 
staff will describe the study to families in more detail and screen for eligibility. During the 
recruitment phone call, verbal consent will be obtained from caregivers prior to completing the 
screening questionnaire and family contact information form. 
During the screening process, research staff will confirm that the caller has the authority to give 
permission for the child to participate in research. A copy of the court order (or other legal 
appointment document) appointing the person as the guardian will be obtained and maintained 
in participant records. The research team will also verify that the guardian’s authority applies to 
granting permission for health care/research and is not limited to just financial matters. If the 
caregiver/guardian does not have authority to give permission (e.g., foster child in county 
custody), the appropriate authority (e.g., caseworker, biological parent) will be consulted by a 
research staff member to determine if permission will be granted. The initial research visit will 
not be scheduled in these cases until permission has been obtained. 
 
Once recruited, families will be sent a visit reminder letter and a copy of the consent/permission 
form to review prior to their first research visit. At the first research visit, project staff will 
obtain written consent from caregivers for their participation and permission for the child to 
participate (if not previously obtained). For children ages 8 or older, the study will be described 
in 
developmentally 
appropriate 
language 
and 
assent 
obtained. 
During 
the 
consent/permission/assent process, research staff will ask if the participant understands the 
content and will offer to answer any questions.
COVID-19 modifications: The approved study consent form has been modified for remote 
procedures during the COVID-19 pandemic. It can be administered through REDCap using 
the eConsent module to allow documentation of consent (following implementation 
with Research and Academic IT). At the end of the screening call, research staff will 
obtain verbal permission from eligible families to send the eConsent by email (see 
screening addendum form). With permission, research staff will then send a REDCap 
link for the study eConsent to eligible participants. Participants can review the consent 
using their personal computer, tablet, or smartphone. Participants can review it prior to 
speaking with research staff or at the start of the baseline data collection call/Zoom 
session. At the start of the call/Zoom session, research staff will ask participants if they 
have any questions relating to the consent document. Participants can sign the eConsent 
in the signature field with their finger, stylus, or mouse. Identity will be verified by 
including several demographic questions after the consent form. These will be 
compared with the demographic information gathered during screening. Research staff 
will confirm the eConsent is signed prior to initiating any data collection. The call will 
be cancelled or rescheduled if needed. After signing the consent, a pdf version of the 
consent will appear on the screen, which participants can download for their records. 
Participants can also choose to have the hard copy study consent form mailed to them 
instead of doing the eConsent. Research staff would then go over the consent with them 
on the phone or Zoom. Participants would then send back the form signed before data 
collection can begin. A modified version of the verbal assent has also been created for 
children 8 or older if families agree to complete the Family Narrative Task (FNT). 
Research staff will administer this verbally with children over the phone/Zoom before 
this task is completed. Video will be used when possible to facilitate child’s 

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engagement/attention. 
4.
METHODS AND STUDY PROCEDURES
4.1.
Study Procedures and Assessments
Study Design: Study aims will be tested within the context of a pilot RCT using a waitlist 
comparison group. Data will be collected at three time points: baseline (T1), immediate post-
intervention (T2), and a 3-month follow-up (T3). Baseline data collection will involve multi-
method and multi-level (standardized questionnaires, interviews, observations, physiological 
measurements) assessment of primary constructs. After baseline data is collected, families will 
be randomly assigned within blocks to the TIK intervention group (TIK) or the delayed 
intervention waitlist comparison group (WLC). The TIK group will then receive the group-
based TIK intervention over the course of 8 weeks. All participants will complete multi-level 
and multi-method assessments at T2. Families in the TIK group will also complete a measure of 
intervention satisfaction at the end of the last TIK session to maintain blindness of RAs to 
group membership. Therapists will also complete a group cohesiveness measure for each 
participant. An abbreviated assessment battery will be administered 3-months post-intervention 
to both groups to assess the maintenance of effects and to test for mediation. Following T3 
research visits (~5-6 months post study entry), families in the WLC group will be offered the 
TIK intervention. 
Assessments:  Table 1 lists the assessment battery for children and caregivers for each time 
point. Primary constructs include parent emotion socialization attitudes and practices, child 
emotion regulation, and child behavior problems.  Sample descriptors and potential predictors 
will also be collected. Research assistants will be trained in all measures. Research visit 
sessions will all take place at MHFC and will be audio and/or video recorded to enable later 
coding. A copy or description of each measure is included in the RSRB application for review. 
Detailed visit protocols are also included for child and parent for each time point. 
COVID-19 Modifications: Due to the COVID-19 global pandemic, any cohorts already in 
progress may complete an abbreviated battery at T2 and T3 by alternate means when in-person 
data collection is not possible. These alternate means may include: via HIPAA-complaint 
Zoom, telephone, and/or by mail. These participants will have already consented to the study 
and completed T1. 
New cohorts can also be enrolled using the COVID-19 modifications described above 
via REDCap. For any participants enrolled remotely, in-person visits will be 
encouraged once we are allowed to return, but if families start the study remotely, they 
can choose to complete remaining visits remotely as well. If participants from new 
cohorts come in for in-person visits for follow-up, the K-BIT2 may be administered to 
the child at T2 or T3. 
Measures included in the abbreviated batteries are marked with an asterisk* in Table 1. 
These measures are questionnaires and interviews that can be completed with parents 
remotely. Parent-report questionnaires can be sent by email/mail and returned, 
completed via REDCap, or administered over the phone/Zoom depending on 
participant preference and ability. Participants can also complete the FNT with their 
child in one of two ways. The first is to have the parent complete the task with the child 
while on Zoom with a research staff member. Alternately families can complete the 
task at a convenient time for them and record with their phone/tablet and sent to 

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research staff. A REDCap survey can be set up to facilitate secure upload/transmission 
of videos for families. Families can also elect not to complete this task. 
When needed, remote telephone communication by staff will be completed using encrypted and 
password protected personal cellular phones. Staff will block caller ID through their phones or 
use *67. See phone and email scripts. 
Table 1: Assessment Battery
T1
T2
T3
CHILD
Height and weight
X
X
X
Kaufman Brief Intelligence Test-2 (20 min)
X
Baseline ECG (Activewave Cardio)
X
X
X
Disappointment Task (5 min) with Activewave Cardio
X
X
NIH Toolbox Cognition Battery (24min)
X
X
     Dimensional Change Card Sort Task (4min)
X
X
     Flanker Inhibitory Control & Attention test (3min)
X
X
     Pattern Comparison Processing Speed (3min)
X
X
     Picture Sequence Memory (7min)
X
X
     List Sorting Working Memory (7min)
X
X
Pictorial Depression Scale (age 4-6) OR Child Depression Inventory-2 (ages 7-12)
X
X
Qualitative Emotion Interview
X
X
Behavior Assessment & Validity Ratings (by examiner)
X
X
X
PARENT
Health & Services Interview (5-8min) / Update
X*
X*
X*
Demographic Survey via REDCap (3-5min) / Update (5min)
X*
X*
X*
Parent Emotion Socialization
     Meta-emotion interview (25-45min)
X*
X*
     Difficulties in Emotion Regulation Scale (2-5min)
X*
X*
X*
     Parent Emotion Styles Questionnaire (3-10min)
X*
X*
X*
Child Emotional & Behavioral Functioning
     Emotion Regulation Checklist (2-10min)
X*
X*
X*
     Strengths and Difficulties Questionnaire (2-5min)
X*
X*
X*
     Eyberg Child Behavior Inventory (5-10min)
X*
X*
X*
Parent Factors
     Parenting Relationship Questionnaire (5-10min)
X*
X*
X*
     Parenting Daily Hassles Scale (3-10min)
X*
X*
X*
     Brief Symptom Index (8-10min)
X*
X*
X*
     Adverse Childhood Experiences Scale (1-3min)
X*
     Couples Satisfaction Index (3-5) if applicable
X*
X*
X*
Child Factors
     Dimensions of Temperament – Revised (5-10min) 
X*
X*
X*
     Traumatic Events Screening Inventory (5-10min)
X*
Client Satisfaction Questionnaire (intervention only)
X*
CHILD-PARENT
Family Narrative Task (15min)
X*
X*
X*
     Prosody Speech Sample (segment selected from Family Narrative Task)
X*
X*
X*
THERAPIST
Group Engagement Measure (for each participant)
X

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All data will be securely stored, processed, and analyzed at MHFC. Two sets of data files will 
be sent to Keri Heilman at the University of North Carolina, Chapel Hill for processing with 
proprietary software: 1) de-identified heart-rate variability data, and 2) brief prosody speech 
samples. De-identified Heart Rate Variability data are collected using Activewave Cardio 
before and after the Disappointment Task. Processing of these data involve extracting the ECG 
and inter-beat-interval data into 2 separate files and aligning then with time-stamps of task 
conditions. Files are then returned to the UR research team for further processing and analysis. 
For the Prosody Speech Samples, brief segments of the child speaking will be selected from the 
Family Narrative Task during discussions of positive and negative family experiences. Only 
about 20 seconds of audio is needed for each event. Segments will be selected by study staff 
that do not include the child’s name or other identifying information. Processing involves 
spectrographic analysis and multiple indicators of prosody are produced using proprietary 
software. Data will be returned to UR research team for further analysis. Video recordings of 
study visits (10%) will be periodically evaluated for fidelity to research protocols by Dr. 
Petrenko. Data scoring and entry will be re-checked to ensure data quality.
A team of coders not involved in data collection will receive training in the coding systems 
used for the Meta-Emotion Interview, Family Narrative, and Disappointment tasks. Trained 
coders will include advanced undergraduate students, graduate students, and MHFC research 
support staff. Inter-rater reliability will be assessed on 20% of measures requiring coding. 
Regular reliability meetings will be held with periodic checks of inter-rater reliability to reduce 
potential for rater drift.
Tuning in to Kids Intervention: TIK (Havighurst & Harley, 2007) is a manualized, group-based 
intervention delivered to parents to improve their awareness, understanding, and responses to 
children’s emotions. In addition to teaching parents the 5 steps of emotion coaching identified 
by Gottman and colleagues (1997), TIK helps parents understand how their family of origin 
experiences with emotion contribute to their current beliefs and responses to their children’s 
emotions. Parents are also taught skills in how to be mindful of their own emotions when 
responding to their children. An 8-session version of TIK will be used in this study, which is 
recommended for groups of families whose children have significant behavior problems. Two 
trained clinicians will co-lead groups on a weekly basis, with an optimal number of 6 families 
per group. Each session lasts 2 hours and includes exercises, role plays, DVD clips, and 
psychoeducation. Childcare will be offered to families to facilitate participation in the program. 
TIK will be delivered at MHFC or other community locations (e.g., church, community center; 
for groups of families that live farther away from MHFC). During COVID-19 restrictions, 
group sessions may be held via HIPAA-compliant Zoom if needed. 
4.2.
Payment for Participation
At T1 and T2 research visits, caregivers receive $50 per visit and children receive $20 or toy 
equivalent per visit. At T3, caregivers receive $25 for the abbreviated visit (1-1.25hr in length 
for caregiver, 15 minutes child) and the child selects a small toy from a prize box (e.g., bulk 
small toy assortment from Oriental Trading). Caregivers do not receive payment for 
participating in the intervention sessions.  
COVID-19 modifications: Parents who complete research visits by alternative methods will 
receive the same payment as they would have for in-person data collection ($50 T1 or T2, $25 
T3), as the measures they will be completing are all the same. The child portion of the visit will 
not be completed remotely, with the exception of the Family Narrative Task. 
5.
RISK/BENEFIT ASSESSMENT

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5.1.
Risks to Subjects
Risks: 
A risk of discovery is possible for families who contact the study whose child has not yet been 
been diagnosed with an FASD. In these cases, Dr. Petrenko will review existing records and 
can complete a brief diagnostic interview with the parent to determine if DSM-5 criteria for 
ND-PAE are met to determine eligibility (see DSM-5 Diagnostic Criteria Checklist for ND-
PAE). Thus, parents may learn their child has an FASD diagnosis in this process (which many 
are seeking when contacting the study). 
Participants may experience psychological risks associated with participation in this study, such 
as discomfort in discussing feelings or aspects of parenting. Some children may not like the 
physical feeling of the ECG recorder used during the Disappointment task. All data collected 
will be kept confidential to the extent allowed by law. If participants disclose (or there are 
significant concerns based on observations) that someone is being maltreated or is a danger to 
self or others, research or clinical staff will need to break confidentiality to make a report to the 
appropriate authority to ensure safety, as mandated by law. It is also possible that caregivers in 
the TIK groups might disclose personal information about other group members to people 
outside of the research studies. We believe that all identified risks are minimal given the 
proposed procedures for protecting against risk.
Protections Against Risk: 
To add protections relating to the risk of discovery, children with confirmed or inconclusive 
NP-PAE symptoms will be referred to URMC FASD Diagnostic Clinic for further medical 
evaluation to ensure all appropriate treatment and care is being provided. 
To minimize risk associated with psychological discomfort, every effort will be made to create 
a non-judgmental and warm environment for all participants in research visits and TIK 
sessions. All research staff will be well trained to administer assessments in a sensitive and 
supportive manner. Participants will also be given the option to skip items during assessments 
if they feel uncomfortable and will be offered breaks as needed. All observational paradigms 
will be monitored by research staff and tasks will be discontinued if the parent or child becomes 
overly distressed or unsafe. TIK groups will be co-led by at least one licensed clinician with a 
Masters-level degree or higher in social work, counseling, psychology, or related fields and 
experience with individual and group-based interventions. TIK group leaders will work to 
create an atmosphere were all parents are comfortable participating and all parents’ experiences 
are respected. Although parents will be encouraged to participate in group discussions, they 
will be permitted to not answer questions or share their experiences if they are not comfortable. 
The well-being of children and their families will be continually monitored throughout the 
course of the proposed research. If there are concerns regarding a participant during research 
visits or TIK sessions, staff will immediately contact Dr. Petrenko for consultation and a plan 
will be developed to address the concerns raised. During the course of the intervention, clinical 
staff will meet weekly to discuss curricula and the intervention process, as well as any concerns 
about individual children or families.  Dr. Petrenko will be on call for any pressing concerns 
that arise during intervention sessions. Additionally, because MHFC provides other treatment 
programs, there are other back-up clinical supervisors available for consultation. Ethically, we 
are committed to ensuring the welfare of children and their families. Any significant mental 
health or safety issues detected during the conduct of this investigation will be discussed with 
participants and options for the receipt of services presented. In the unlikely event of adverse 

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effects of the intervention or evaluation on participants, adverse events would be reported to the 
RSRB and NIAAA.  See Data and Safety Monitoring Plan below. 
All information obtained for research will be kept strictly confidential (as allowed by law) by 
research staff. Participants will be told about all exceptions (e.g., child/dependent adult abuse, 
harm to self or others) to confidentiality during the consent process. Research and clinical staff 
will be closely supervised and instructed on confidentiality, including what information is 
confidential, the limits of confidentiality, and to whom to report concerns. If maltreatment is 
suspected, staff will first discuss their concerns with the caregiver and inform him/her that, as 
indicated in the consent form that she/he had previously signed, our staff are ethically and 
legally obligated to file a report with Child Protective Services. We have found that this 
approach conveys respect for the family and mitigates parental anger that might otherwise 
emanate from filing a report. In our experience, when situations requiring filing a maltreatment 
report are handled sensitively and framed as stemming from concern for the welfare of the 
entire family, caregivers often perceive the process as being helpful to them. Finally, while it is 
not possible to control what participants do outside of group settings, we will thoroughly 
explain the concept and importance of confidentiality and give real life examples of what is 
appropriate and inappropriate to discuss with people outside of the group.
In terms of data storage and management, all hard copy data, including videotapes, will be 
secured in locked file cabinets within locked offices, available only to program staff. Electronic 
data will be stored in secured servers, and only program staff with knowledge of the password 
will be able to access the data.  Forms with identifying information will be separated from the 
data collected and only subject numbers will be retained in data analysis files.
5.2.
Benefits to Subjects
Children and their families might not benefit from their participation in TIK intervention (both 
the intervention and delayed-waitlist group will receive intervention). If the TIK intervention is 
found to be efficacious and is subsequently made available, other nonparticipating children 
with FASD may benefit from future participation in this intervention. Parent training 
interventions on emotion socialization have the potential to better support the emotion 
regulation development of children with FASD and reduce mental health problems in this 
population. 
5.3.
Alternatives to Participation
The alternative to participation is not to participate. Participation in the project does not prevent 
families from continuing or seeking other services of interest to them.
6.
CONFIDENTIALIATY OF DATA AND INFORMATION STORAGE 
Sources of data will include: screening questionnaire from initial enrollment call to establish study 
eligibility; data obtained from participants during research visits on questionnaires, interviews, 
standardized child tasks, and observational coding of parent and child during research paradigms; 
heart rate data collected with Activewave Cardio ECG equipment; parent satisfaction ratings and 
qualitative interviews post-intervention; rating forms completed by clinicians for each participant 
following each TIK session; and intervention fidelity checklists. 
All data will be used solely for research purposes and will be permanently securely locked in 
designated file cabinets or secure data servers at MHFC. Only senior key personnel and relevant 
research staff will have access to data. Identifying information, records (e.g., FASD evaluations, legal 
records) and consent/permission/assent forms will be stored separately from other data, which will be 
stored by subject number. The electronic file linking identifying information and subject number will 

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be maintained indefinitely, but will be stored separately where only the PI and senior research staff 
have access. De-identified data will be entered and scored in secure electronic databases for later 
analysis. Data will be reported in aggregate with no participant identifying information provided. 
7.
RESEARCH INFORMATION IN MEDICAL RECORDS
No information about study participation or research responses will be recorded in eRecord.
8.
DATA ANALYSIS AND DATA MONITORING
8.1.
Planned Statistical Analysis
Data reduction plan. Data reduction procedures will establish indicators for planned analyses. 
First, reliability indices will be calculated to confirm scales have adequate internal consistency. 
Next, preliminary exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) 
will be used to determine the appropriate factor structure for the Meta-Emotion Interview 
(MEI) in this sample for further analysis. Associations between the resulting MEI scales and 
the Emotion Coaching and Emotion Dismissing scores from the Family Narrative Task will be 
examined to evaluate construct validity and determine whether they provide unique information 
for analyses. EFA and CFA will also be used to determine whether the multi-method indicators 
of child emotion regulation and parent socialization of emotion can be combined to create latent 
factors to be used in Aims 2 and 3.
Aim 1: To test the hypothesis that specific baseline parent and child characteristics are related 
to individual differences in parent emotion socialization. Zero-order correlations will be 
examined between measures of parent emotion socialization and proposed parent 
(psychopathology, perceived stress, ACEs) and child (sex, age, temperament) characteristics. 
Multivariate regression modeling will be conducted to evaluate the unique associations of 
significant zero-order predictors when controlling for the variance accounted for by other 
factors. For example, multivariate regression will be employed to determine how one 
characteristic, such as child temperament, uniquely relates to indices of emotion socialization, 
over and above child age and sex.  
Aim 2: To test the hypothesis that specific parent emotion socialization attitudes and practices 
at baseline are associated with more adaptive levels of emotion regulation in children with 
FASD. Correlations will be examined between indices of parent emotion socialization and child 
emotion regulation. Multivariate correlation and regression analyses will then be conducted. 
For example, child emotion regulation will be modeled as the dependent variable and indices of 
parent emotion socialization and child sex will be included as independent variables. Canonical 
correlation procedures will also be considered to address aim 2. Standardized canonical 
coefficients for individual parent emotion socialization variables can provide information on 
the relative strength of association with the emotion regulation variable set. In the case that 
emotion regulation variables do not load on a single factor during data reduction procedures, 
separate multiple regression analyses will be considered.   
Aim 3: To test whether the Tuning In To Kids intervention results in significant improvements 
in parent and child outcomes and to determine whether parent emotion socialization represents 
a mediator of the TIK intervention effect on child emotion regulation and/or behavior. Intent-
to-treat analyses will be conducted and missing data will be handled using Full Information 
Maximum Likelihood (FIML) techniques in structural equation modeling (SEM) when 
appropriate. Covariates such as child age, baseline severity of problems, type of caregiver, etc 
will be considered. Propensity score (PS) procedures will test for bias in randomization 
(Rosenbaum & Rubin, 1983). PS estimates the probability that a subject is assigned to a 

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particular condition given a set of known covariates. PS is used to reduce selection bias by 
equating groups based on these covariates.  
A series of repeated measures analysis of covariance (ANCOVAs) will be conducted to 
determine stability and change in parent emotion socialization, child emotion regulation, and 
child behavior problems. Covariates will include child sex and age. We will investigate 
intervention group status by time interactions to test whether changes in outcomes (i.e., parent 
emotion socialization, child emotion regulation, child behavior problems) over time depend on 
intervention group status (intervention group X time effects). Latent growth curve modeling 
(e.g., Curran & Muthen, 1999) will also be used to examine the effect of TIK on trajectories of 
parent emotion socialization, child emotion regulation, and child behavior problems across the 
3 time points. 
To test whether changes in parent emotion socialization practices at post-intervention (T2) 
mediate the effects of TIK on child outcomes including child emotion regulation and child 
behavior problems at the 3-month follow-up (T3), re-sampling methods, such as the bias-
corrected bootstrap will be used. This approach to mediation testing has been recommended by 
MacKinnon and colleagues (2004) because the distribution of the indirect effect is rarely 
normally distributed. In addition to significance testing, the effect sizes of the mediated effects 
will be examined and compared (MacKinnon, 2008). Regarding model specification for the 
mediation analysis, the effect of TIK on the hypothesized T2 mediator parent emotion 
socialization (‘a’ path), will be represented by the effect of TIK on the T2 mediator, controlling 
for mediator at T1. The effect of TIK on T2 child emotion regulation, controlling for T1 child 
emotion regulation, will also be modeled. To examine the effect of T2 parent emotion 
socialization on T3 child emotion regulation (‘b’ path), T2 child emotion regulation will be 
partialed out. For ease of interpretation, only the primary mediational paths of interest (‘a’ and 
‘b’ paths) are depicted in Figure 3.
8.2.
Data and Safety Monitoring
Because the proposed research involves the provision of group-based emotion-focused 
parenting program, the risk for a serious adverse event due to provision of the intervention is 
low. Adverse events that could occur in children with FASD or their caregivers could include 
aggression or violence towards others, maltreatment, self-harm or suicidality, or the need for 
inpatient hospitalization. However, these occurrences are unlikely to be a direct consequence of 
participation in the proposed research or interventions. 
Ongoing safety of research participants will be monitored by an independent safety monitor. 
Fred Rogosch, Ph.D. is a clinical psychologist and senior researcher at MHFC who has served 
as a long-standing member of the RSRB. He also has experience serving on Data Safety 
Monitoring Boards for high-risk studies at MHFC. Dr. Rogosch will have no direct 
involvement in the project. In his role as an independent safety monitor for this study, he will 
review and suggest modifications to research protocols and consent documents to assure 
scientific integrity and adherence to human subjects protection policies. He will meet with the 
PI and co-Investigators bi-annually to monitor safety issues and provide feedback on scientific 
and ethical issues relating to project implementation. The RSRB will be notified immediately of 
any adverse events via telephone and submission of a “University of Rochester Serious 
Adverse Event Report.” Such events would also be reported to NIAAA. 
Dr. Petrenko will assume ultimate responsibility for the safety and well-being of research 
participants and the integrity of data collected. Dr. Petrenko has conducted one small-scale 
RCT and several pilot feasibility studies with children and teens with FASD and their families. 

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Drs. Petrenko, Handley, and Toth are licensed psychologists in the state of New York and are 
competent assessing and responding appropriately to adverse events. Drs. Petrenko, Handley, 
and Toth are involved in other clinical and research activities at MHFC where maltreatment and 
suicidality are commonly reported. Dr. Toth has also conducted several large-scale RCTs with 
high-risk populations at MHFC. She was a mentor on Dr. Petrenko’s Career Development 
Award and continues to meet with Dr. Petrenko at least twice a month. She will provide 
continued consultation on the current project and will advise on data integrity and participant 
safety.   
Quality control and participant safety will be ensured via weekly supervision of research and 
clinical staff by Dr. Petrenko. Survey data will be examined immediately after interviews have 
been conducted, to ensure that any reportable information will receive immediate and 
appropriate action. Such action will be to report knowledge of: 1) new child abuse or neglect, or 
2) information that someone is at risk of being harmed or of harming themselves. This 
information will be reported to the appropriate authorities and child’s legal guardian. If 
participants are at imminent risk, they will receive prompt medical attention. Limits of 
confidentiality will be clearly delineated in the consent, permission, and assent forms. Program 
staff will ensure that informed consent documents are properly explained and signatures 
obtained prior any subject’s participation. Clinical staff will regularly monitor participant safety 
and well-being during intervention sessions and will follow procedures discussed above. All 
staff will be instructed to report any adverse events to the Principal Investigator immediately 
and the investigator will subsequently report this to the RSRB and NIAAA. Fidelity to research 
and intervention protocols will be monitored through weekly supervision and spot-checking of 
audiotapes of sessions.
In terms of data storage and management, all hard copy data, including videotapes, will be 
secured in locked file cabinets within locked offices, available only to program staff. Electronic 
data will be stored on a secured server, and only program staff with knowledge of the password 
will be able to access the data. Forms with identifying information will be separated from the 
data collected and only subject numbers will be retained in data analysis files.
9.
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