Coaching Alternative Parenting Strategies (CAPS) Study: Targeting Neurobiological and Behavioral Mechanisms of Self-regulation in High-risk Families
Phase: NA
Conditions: Child Abuse, Self-control, Parenting
Sponsor: University of Oregon

Coaching Alternative Parenting Strategies (CAPS) Study: Targeting Neurobiological and 
Behavioral Mechanisms of Self-regulation in High-risk Families 
 
NCT #02684903 
Date: 09/2/2020 
CAPS Study Protocol 
 
 
Screening Procedures 
 
This randomized controlled trial received ethics approval from the University of Oregon 
Institutional Review Board as well as the State of Oregon’s Department of Health and Human 
Services. A DHHS certiﬁcate of conﬁdentiality was obtained to further protect the identity of 
research subjects in the study. Parents and guardians provided written informed consent to 
participate, and children gave verbal assent prior to engaging in any study procedures. 
 
Eligible families were identiﬁed and recruited to participate in the clinical trial through the 
Department of Human Services (DHS) Child Welfare and Self Sufﬁciency divisions. DHS staff 
members identiﬁed eligible families from their database if the primary caregiver had 1) no 
history of perpetrating sexual abuse and 2) a child between 3 and 8 years old. Following this 
pre-selection process within DHS, a core member of the CAPS research team contacted each 
family to invite them to participate in the study and further screen them for eligibility. Families 
were free to participate or decline and were informed that they would be randomized to either 
the PCIT intervention or would be provided services as usual after completion of their baseline 
assessment. Interested families were screened for eligibility on the following criteria: (a) the 
participating parent was at least 18+ years old at study entry and (b) is the participating child’s 
biological or custodial parent; (c) the participating child was between 3 and 7 years old at study 
entry; (d) no parent or caregiver in the home was a documented child sexual abuse perpetrator 
per child welfare records, (e) the parent spoke sufﬁcient English to engage in the assessment, 
and (f) the parent provided written informed consent to participate. 
 
Clinical Trial Design 
 
Two assessments were completed for all study families (pre-treatment and post-treatment), 
and a mid-treatment assessment was completed for PCIT families only. Each of the pre- and 
post-treatment assessments consisted of two separate visits that were scheduled 
approximately one week apart. Following completion of both visits in the pre-treatment 
assessment, families were randomly assigned to one of two conditions in this parallel groups 
design: PCIT treatment or Family Services-as-Usual (SAU) control. Families were 
overallocated to the intervention condition at a rate of 1.5:1 to ensure an ample number of 
families accessed the intervention. Random assignment to condition was retained through the 
overallocation process. Allocation was concealed from research assistants who collected 
data at all assessment waves. 
 
Pre-treatment assessments were conducted on enrolling families from spring, 2016 through 
spring, 2019. Mid-treatment and post-treatment assessments were conducted through 
March, 2020, and ceased due to the COVID-19 pandemic shutdown. Families randomized 
to PCIT complete post-treatment immediately after their last PCIT session, or 
approximately 9–12 months after study entry for those who discontinued PCIT prematurely. 

Families randomized to SAU control complete post-treatment approximately 9–12 months after 
study entry. Post-treatment assessments for the SAU control families were case control 
matched with the PCIT group on time from study entry to post-treatment assessments.   
Assessment Procedures 
 
Pre-treatment and post-treatment assessments were conducted with all participants in the study, 
each completed in two successive laboratory visits scheduled one week apart. Mid-treatment 
assessments were conducted only with PCIT intervention families, after completion of the ﬁrst 
PCIT phase (i.e., child-directed interaction, CDI) and before beginning the second PCIT phase 
(i.e., parent-directed interaction, PDI). Mid-treatment assessments were completed in one 
laboratory visit. Pre-treatment, mid-treatment, and post-treatment assessments each included joint 
parent-child tasks, individual child tasks, and individual parent tasks. Cardiac physiology was 
monitored at rest, with participants watching a neutral video either jointly before parent-child tasks 
or individually before solo tasks. Cardiac physiology was also measured during all experimental 
tasks and during recovery periods (where participants again watch a neutral video) immediately 
following each task (see physiology acquisition details in Outcome Measures below). Parents were 
compensated for their time at each visit, offered paid taxi services or reimbursed for transportation, 
and children were given a small prize. Detected child maltreatment outcomes will be evaluated 
using the state-wide child welfare administrative database, with matches based on unique 
identiﬁers for the participating child and individual unique identiﬁers for the participating parent. All 
database matches will be manually checked to conﬁrm any positive matches for future 
maltreatment reports where the participating study parent is identiﬁed as the perpetrator. Any 
reports made by study therapists will be considered “surveillance effect” reports and treated 
appropriately in data analyses. 
 
Pre- and Post-Treatment Assessment 
 
Following voluntary informed consent procedures, parents and children completed 
anthropometric measures (i.e., standing height, weight, and waist circumference) and were 
ﬁtted with seven disposable, pre-gelled electrodes for the recording of electrocardiogram 
(ECG) and impedance cardiogram (ICG). ECG was measured from three electrodes placed in a 
modiﬁed Lead II arrangement on the distal right clavicle, lower left rib, and lower right 
abdomen. ICG was measured from two electrodes placed on the participant’s midline along 
the top end of the sternum between the two clavicles, at the bottom end of the sternum where 
the ribs meet, and two electrodes along the spine. ECG and ICG data were wirelessly 
transmitted via an ambulatory impedance cardiograph (Mindware Mobile #50-2303-00; 
Mindware Technologies, Westerville, OH, USA) to a desktop computer equipped with 
Mindware’s Biolab (2.4) acquisition software that integrates simultaneously recorded audio and 
video. Both parents and children wore a vest throughout each visit that secures the wireless 
ambulatory monitor close to their body and allowed them to move freely during the tasks. 
Cardiac physiology was monitored throughout all tasks at each visit for both parents and 
children. After children and parents were ﬁtted with the electrodes, a 3-min resting baseline 
measure of parent and child’s concurrent cardiac physiology was obtained while they were 
sitting quietly together and watching a neutral video of oceanic animals. Immediately afterward, 
systolic and diastolic blood pressure, and resting pulse were assessed via blood pressure 
cuffs, while the parent and child remained sitting. 
 
Following assessment of initial resting cardiac physiology, dyads completed two joint 
interaction tasks that were video- recorded and during which cardiac physiology was collected. 

First, the standard PCIT Dyadic Assessment Protocol (33) employed a standard set and 
arrangement of toys that were spread out on the playroom ﬂoor for all dyads. Parents were 
provided with an earbud and walkie-talkie to allow assessors to provide task instructions while 
parents were alone in the playroom with their child. The PCIT dyadic assessment protocol 
consists of three 5-min parent-child interactions: a 5-min Child-Led Play task (i.e., please 
follow your child’s lead…); followed by a 5-min Parent-Led Play task (i.e., now you decide on 
what you two will play…), and a 5-min Clean-Up task (i.e., it’s time for your child to clean up all 
of the toys). After the interaction, the parent’s earbud was removed, and cardiac physiology 
was assessed during a 2-min joint recovery before the dyad began the second interaction 
task. Dyads then completed the Social Engagement task (SET) during which the child and 
adult are seated in close physical proximity while completing three reciprocal activities: (1) 
gently pointing to the other’s facial features (i.e., hair, chin, nose, and ears); (2) counting each 
other’s ﬁngers; and (3) whispering a story in each other’s ear. Children completed the task 
twice: once with their parent and once with a female research assistant. Each activity was 
presented for a ﬁxed time interval and the story told by the research assistant was the same 
with all families. Activity order remained consistent across dyads, whereas the interactive 
partner condition (i.e., parent or research assistant) was counterbalanced within assessment 
wave. That is, children were randomly assigned to a partner order that remained constant 
throughout subsequent assessment waves. Cardiac physiology was assessed in another 2-
min joint recovery immediately after completing the SET, and then, blood pressure 
readings were obtained. Parents and children were given a short break and small snack prior 
to transitioning into individual tasks. 
 
Parents were taken to a separate testing room in the lab, where the Mindware Mobile carrier was 
removed and replaced with Biopac carriers for ECG and ICG [Dual Wireless Respiration and 
ECG BioNomadix Transmitter (BN-Tx); Biopac Systems, Inc.]. Next, parents were ﬁtted with a 
256-channel high density Electrical Geodesics Inc. (EGI Philips; Eugene, OR) Hydrocel 
Geodesic Sensor Net while their child observed. EEG was recorded at a sampling rate of 500 Hz 
using the EGI net and Net Amp 300 ampliﬁer integrated with Net Station software version 5.2.0.2 
(EGI Philips; Eugene, OR). Parents completed a 4-min resting EEG task in which they ﬁrst closed 
their eyes for 2 min and then ﬁxated on a blank screen for 2 min while seated in a dark room. Next, 
a 3-min resting baseline measure of cardiac physiology was collected while parents and 
children watched a neutral ocean video. Parents completed the executive function tasks 
[Auditory Attention (AUDAT) and Stop Signal; speciﬁed in Outcome Measures below] while 
simultaneous EEG and cardiac physiology were recorded. Parents completed an Emotional 
Go/No-Go task to conclude visit #1. Meanwhile, children completed two subtests of the 
Woodcock Johnson-III Tests of Achievement and two brief self-regulatory tasks [Head-Toes-
Knees-Shoulders (HTKS); Working Memory] while cardiac physiology was monitored during 
each task and for 2- min recovery periods after each task. Note that children’s cardiac physiology 
was recorded during an additional 2-min standing baseline prior to the HTKS task. 
 
Families returned to the lab for a second 2-hour visit within one week of their initial visit. During 
visit #2, children were ﬁtted with a 64-channel EGI Hydrocel Geodesic Sensor with identical 
EEG equipment and acquisition software to that used with parents. Children completed 
executive functioning tasks (AUDAT and Zoo Go/No-Go) while simultaneous EEG and cardiac 
physiology were recorded. Children then completed the Emotional Go/No-Go task while cardiac 
physiology was recorded. During this time, parents completed questionnaires that allow for the 
assessment of socio-demographic characteristics, environmental risk, and child behavior (see 
Outcome Measures). After parents and children both completed individual tasks, peak 

expiratory ﬂow (i.e., cardiovascular function) was measured using a spirometer, and the 
highest of three values was recorded within-person. Next, whole blood spots were collected 
from both parents and children to assess intervention effects on metabolic and immune 
markers. Four to ﬁve spots of blood (~50 ml each) were collected on Whatman strips, then were 
dried, processed, and frozen at −20°C, before samples were transferred for storage in a pad-
locked −80°C freezer to undergo enzyme-linked immunosorbent assays (ELISA). All 
research assistants responsible for collecting blood spots ﬁrst completed a 
comprehensive Bloodborne Pathogens training that outlined emergency procedures, safe 
handling, contact risks, and exposure control plan, prior to working with participants. 
Research assistants used disposable masks that cover the nose and mouth, goggles, and 
disposable gloves. At the end of the pre-treatment assessment, the parent was given a sealed, 
double-blind randomization letter after completing questionnaires and prior to collection of 
allostatic load measures. If the family was randomized to the PCIT treatment condition, a 
research assistant reviewed the basic structure and goals of PCIT with the parent, gave a brief tour 
of the PCIT clinical rooms, and scheduled the family for an intake session with an available 
therapist. 
 
Mid-Treatment Assessment 
 
Only families who were randomized to the PCIT condition and engaged in treatment sessions 
were invited to complete a mid-treatment assessment. Written informed consent from the 
parent and verbal assent from the child were obtained. During this single-visit assessment, 
dyads completed assessment tasks noted above using identical procedures unless speciﬁed 
here. Parent and child provide anthropometric measures (i.e., height, weight, and waist 
circumference) and then were ﬁtted with seven disposable, pre-gelled electrodes for recording 
cardiac physiology during a 3-min joint resting baseline. Dyads completed the PCIT Dyadic 
Assessment Protocol during which cardiac physiology data were collected. Cardiac physiology 
was recorded during a 2-min recovery. Children then completed the Social Engagement task 
with their parent only (not a research assistant) during the mid-treatment assessment. Cardiac 
physiology was collected again during a 2-min post-task recovery. Parents and children took a 
short snack break and then transitioned to individual tasks. Parents then completed the Stop 
Signal task, during which only behavioral data was collected (i.e., no EEG or cardiac 
physiology) due to time constraints. Parents completed a subset of the questionnaires that 
were presented at pre-treatment. Separately, children completed a 3-min measure of resting 
cardiac physiology while standing, followed by the HTKS task. Children’s cardiac 
physiology was then recorded during a 2-min recovery. Next, the child completed a sitting 3-
min resting baseline, followed by the Zoo Go/No-Go task. Neither children nor parents 
provided EEG data during the mid-treatment assessment due to time constraints. After 
completion of individual tasks, whole blood spots and measures of peak expiratory ﬂow were 
collected from both parents and children. 
 
Outcome Measures 
 
Dyadic Parent-Child Interactions 
 
Video-recorded parenting behaviors and child responses during the standard PCIT Dyadic 
Assessment Protocol (i.e., child-led play, parent-led play, and clean-up tasks) at pre-treatment, 
post- treatment, and mid-treatment were collected, transcribed and then coded using the well-
validated Dyadic Parent-Child Interaction Coding System, Fourth Edition (55) (DPICS-IV). For 

the PCIT intervention group, DPICS-IV coding was also completed on parent-child interactions 
during Child Directed Interaction (CDI) sessions (i.e., standard, 5-min child-directed play 
segment) and standard Parent Directed Interaction (PDI) session segments that began with 
the 5-min child-directed free play segment (see PCIT Intervention and Delivery below). PCIT 
session coding was conducted using only the session video-recordings (i.e., without 
transcripts). Parenting behaviors that were coded include labeled praises, unlabeled praises, 
behavior descriptions, and reﬂections; criticisms, direct and indirect commands, questions, 
and neutral talks. Children’s compliance and non-compliance behaviors in response to 
parent commands were coded. Commands where children have no opportunity to comply 
were also coded. Coders completed 20 hours of intensive, hands-on training prior to coding 
study assessments, and continued to meet regularly to maintain 80% inter-rater reliability. All 
coders were blind to participants’ condition group and assessment wave. Parent and child 
behaviors were coded sequentially and summed to calculate a task average for each behavior. 
For assessment visits (i.e., pre-treatment, mid-treatment, and post-treatment), values were also 
summed in 30-sec epochs within each task and summarized into task averages. Reliability 
coding was completed on 20% of study families, with criterion set to 80% interrater reliability. 
 
Cardiac Physiology 
From ECG/ICG recordings of cardiac physiology, RSA and pre-ejection period (PEP) were 
assessed as indices of the parasympathetic and sympathetic nervous systems, respectively. 
RSA is derived from high-frequency heart rate variability measured in the ECG (children, 0.24 
to 1.04 Hz; adults, 0.12 to 0.40 Hz). PEP is derived by measuring the distance between the Q-
point of the ECG and the B-point of the dZ/dt wave, indexing the time interval between opening 
of the left ventricle and ejection of blood into the ventricle. Heart rate is evaluated from the 
ECG as the number of R-R wave intervals per minute. Both RSA and PEP are measured in 
30-s epochs, except during the Emotional Go/No- Go task (described below) during which they 
are assessed for the task duration. All data was cleaned ofﬂine using Mindware HRV analysis 
software version 3.1.1.  Data were visually inspected and cleaned for movement artifacts and 
equipment errors. 
 
Neurophysiology 
 
EEG was acquired from parents and children during rest periods and completion of executive 
function tasks (i.e., Stop Signal, Go/ No-Go, and AUDAT) during T1 pre-treatment and T3 post- 
treatment sessions only. EEG was recorded at a sampling rate of 500 Hz using an EGI 
Hydrocel Geodesic Sensor Net integrated with Net Station software (Electrical Geodesics Inc; 
Eugene, OR). After recordings were completed, raw EEG ﬁles were exported from Net Station 
in simple binary format to prepare them for preprocessing. After preprocessing, continuous 
EEG ﬁles were epoched into task-speciﬁc bins by time-locking EEG to event codes 
synchronized with events of interest, to yield ERPs for analysis. Each epoch was subjected to 
standard artifact rejection procedures. Final processed ERP ﬁles for a given participant for 
each task will consist of all artifact-free epochs of interest, relative to a 200-ms pre-stimulus 
baseline. Grand averages are created for each task by averaging across groups of 
participants. 
 
Attentional Control 
 
Parents and children individually complete the Auditory Attention Task (AUDAT) to assess 

attentional control. Participants listen to one of two children’s stories presented simultaneously 
in separate free-ﬁeld speakers situated 90° to their left and right sides. During each story, one 
speaker presented a male voice while the other speaker presented a female voice, each 
reading different narratives ranging from 2.5 to 3.5 min in length and edited to remove pauses 
greater than 1 second. An arrow on the screen reminded the participant which story to attend 
to. Selective attention during the task is assessed via ERPs recorded to 100-ms sound probes 
(i.e., ba, buzz sounds) superimposed on the to-be-attended and unattended stories. Each 
participant attends to four separate stories over the duration of the task, with direction of 
attention counterbalanced across gender of narrator (male or female) and side of speaker (left  
or right)  with a pseudo-randomized order. Immediately after each story, the participant was 
asked three comprehension questions to ensure they were attending to the appropriate 
narrative. 
 
Inhibitory Control 
 
Parents complete two 6-min blocks of the Stop Signal task to assess response inhibition and 
impulse control. A stop-signal response time (SSRT) was calculated as the difference 
between the speed of the stop process and the stop signal delay, reﬂecting efﬁciency of the 
inhibitory control process. Each block of the task consists of 128 trials (32 stop trials) and 
lasted 6 min. Total testing time was approximately 12 min for 256 trials. Of interest were ERPs 
time-locked to the stop signal and ERPs time-locked to responses, for example, N2 and P3 
ERP components shown to be enhanced in amplitude on trials that are correctly inhibited. 
 
Participating children completed four 2.5-min blocks of a Zoo Go/No-Go task to measure 
inhibitory control. Children were presented with a story of a zookeeper and instructed to 
respond by pressing on a button box each time a zoo animal appears on the computer monitor 
(go signal). After 12 practice trials, they are told to withhold their response each time they see a 
monkey. On No-Go trials (i.e., monkey stimulus), children were given feedback for their 
responses, with a smiley emoticon for correct responses and correctly withheld responses, and 
an angry emoticon for incorrect responses (i.e., did not withhold or did not respond). After a 
brief practice period that includes the monkey and emoticon feedback, children complete four 
blocks of 45 trials each, with short breaks in between blocks, for a total of 180 trials. Of these, 
33% of trials per block are no- go trials. Children also completed the Head Toes Knees 
Shoulders task (HTKS), adapted for use with ages 4–8, to assess behavioral response 
inhibition, and with McClelland’s modiﬁcations, is appropriate for use with children aged 3 to 7 
years. Children are introduced to four instructions, “touch your head,” “touch your toes,” “touch 
your shoulders,” and “touch your knees.” After a series of non-conﬂict trials in which they do as 
instructed, children were told to respond using the “opposite” rule to the examiner (e.g., touch 
head when examiner says touch toes). A total of 30 trials were presented, with responses 
scored as correct, self-corrected, or incorrect.   
 
Emotion Regulation  
 
Parents and children also complete Emotional Go/No-Go tasks to assess emotion regulation. 
Stimuli were images of neutral, angry, happy, sad, and fearful facial expressions for 
parents, and only neutral, happy, or angry for children. Parents and children each completed 
an age-appropriate version of the task, in which they were instructed to press a response key 
when a target emotion was presented, and to refrain from responding when a distractor 

emotion was presented. 
 
Survey Measures 
 
Parents are asked to report on both their own and their child’s adverse life experiences, 
attributions, socio-emotional functioning, general health, and relationships. In addition, parents 
report on their parenting stress, children’s trauma symptoms and children’s behavior. All 
questionnaires are completed in interview format with a trained research assistant. Parents are 
given a small booklet of scales for Likert-type questions, which they can point to when 
responding. Responses are entered into Qualtrics by the research assistant and automatically 
scored. Table 1 includes a list of survey measures. 
 
PCIT Intervention and Delivery 
 
PCIT is an intensive, behavioral parent-training intervention model grounded in social learning, 
attachment, and family systems theories that uses live skills coaching of parent-child 
interactions. Families were scheduled for PCIT sessions in the morning, afternoon, and 
evening on weekdays and on weekends per family preferences. During sessions, parents wear 
a small earpiece while the therapist coaches via a headset from the other side of a one- way 
mirror, providing positive feedback, support, and guidance. Each session was 50–60 min long. 
The PCIT intervention is assessment-driven and includeed weekly DPICS coding of parent 
skills mastery at the beginning of each PCIT session to guide the coaching focus, and parent 
ratings of child behavior problems using the Eyberg Child Behavior Inventory (ECBI). (See 
PCIT International guidelines). Parents in the intervention condition were invited to complete a 
second optional informed consent if they wished for their PCIT therapist to provide a routine 
progress report to their DHS caseworker. No additional study data, aside from the optional 
progress reports and any mandated maltreatment reporting, was shared with DHS authorities. 
Families were provided light snacks at each visit and reimbursed for transportation costs to 
attend sessions. Treatment was suspended or discontinued if the child was removed from the 
home entirely during the course of treatment; however, families were retained in the study 
through the T3 post-treatment assessments when possible.  
 
Interventionist Training and Fidelity 
 
A team of eight masters or Ph.D. level practitioners completed an intensive 40-hours training 
with Dr. Funderburk and her clinical team of nationally certiﬁed PCIT trainers at Oklahoma 
University Health Sciences Center (OUHSC) and delivered the PCIT intervention to CAPS 
study families. PCIT therapist training conformed to PCIT International standards for 
observed case practice and intervention ﬁdelity criteria. Study therapists received ongoing 
weekly consultation from Master and Level II Trainers at OUHSC, in addition to live, video-
based consultation during conduct of their PCIT sessions with study families. Adherence to the 
protocols was assessed using live, remote, direct observation of sessions and by completing 
session-by-session ﬁdelity checklists following each session. All PCIT sessions were 
videotaped to ensure rigorous adherence to the PCIT protocol and a minimum of 10% of 
videotaped sessions wereoded for ﬁdelity by independent observers blind to family outcomes 
at 90% criterion. 
 
Services-as-Usual-Control Condition 
 

The Services-as-Usual (SAU) control condition was an ecologically valid, ethical comparison 
group in which families receive typical services provided by child welfare agencies, including 
access to a variety of in-home family visitation services, respite childcare, and other individual 
child counseling and/or parent education training. Parents completed a Services Utilization 
Questionnaire via interview at post-treatment, indicating how many times in the past 6 
months anyone in the family received support from a wide range of social services. Thus, 
services utilization was tracked via parent self-report at T3 post-treatment for all study families.