Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
Phase: NA
Conditions: Disruptive Behavior, Aggression Childhood, Anger, Non-Compliance, Patient, Irritable Mood
Sponsor: Yale University

Study Title: Digital delivery of parent 
training for disruptive behaviors: Increasing 
Access to Care 
 
 
HIC Protocol Title: Cognitive-Behavioral Therapy for Disruptive Behavior in Children and 
Adolescents 
*Note: Study is included within a broader HIC Protocol 
 
Unique Protocol ID: 0102012121-E 
 
 
 
 
Date of Document Approval: 8/28/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sukhodolsky Lab 
Yale Child Study Center 
 

AACAP Pilot Research Award Letter of Intent 
Andrea Diaz Stransky (Page 1) 
Digital delivery of parent training for disruptive behaviors: Increasing Access to Care 
 
I. Significance and Specific Aims: Disruptive behaviors are among the most common reasons for mental 
health referral in children, and among the most costly childhood conditions.1 One-third to one-half of 
children with disruptive behavior disorders also meet criteria for ADHD, and comorbidity typically worsens 
the prognosis.2,3 Parent training programs are clinically effective in the treatment of children’s disruptive 
behaviors, and are included in the recommendations set forth in AACAP and AAP treatment guidelines. 
However, such behavioral treatment is inaccessible to most families in need.4 Barriers include distant 
location, high cost, parents’ limited time availability, lack of trained staff, stigma and skepticism of the 
pediatric mental health system.4 The underutilization of parent behavior management training for disruptive 
behaviors was identified as a practice gap by AACAP in 2017.5 Despite AACAP and AAP guidelines, 
children are often prescribed psychotropic medication without evidence-based behavioral interventions 
such as parent training.6 To overcome some of these barriers to high quality care, online delivery of 
evidence-based parent management training (Digital Parent Training (DPT)) has been developed.7 While 
most DPT interventions have demonstrated feasibility and acceptability, the majority provide only self-
guided static content without clinical guidance, or the capacity for ‘dose-adjustment’ or gradual escalation of 
care based on participants’ needs.8 Thus, existing web-based approaches miss the opportunity to identify 
treatment obstacles early and to refer children to a higher level of care if needed. We propose to test a 
model of interactive DPT (iDPT) for disruptive behaviors and irritability in young children that augments 
traditional digital parent training with interactive clinical guidance and consultation. Content for this iDPT 
approach closely follows core principles and techniques of parent-training methods that have been 
thoroughly tested in clinical trials at the Yale Child Study Center.9-11 Through the iDPT program, clinicians 
will provide parents with support and guidance through “in-app” asynchronous messaging, scheduled 
video-conferencing and can facilitate referral to the Yale Child Study Center Outpatient Clinic when 
necessary. Our long-term goal is to run a large RCT to study the clinical efficacy of interactive DPT for 
disruptive behaviors in children across multiple sites and populations. We must first establish acceptability 
and feasibility of this approach with an open trial before proceeding to a larger RCT. 
 
Specific aim #1: Examine acceptability and feasibility of iDPT in children with clinically significant levels of 
irritability and disruptive behavior, ages 4 to 9 years. Acceptability and feasibility will be assessed by 
percentage of enrollment, completion of the online modules, and the Patient Satisfaction Questionnaire 
(PSQ).6  
We hypothesize that >80% of enrolled subjects will complete all of the online modules and attend 2 of the 3 
videoconferencing sessions. We hypothesize that the majority of parents will rate the iDPT as acceptable 
based on the Patient Satisfaction Questionnaire (PSQ), as evidenced by an average score of 3.0. 
 
Specific Aim #2: Analyze the effect of iDPT on child disruptive behaviors as measured with the Disruptive 
Behavior Rating Scale (DBRS).12 
We predict that children whose parents complete the intervention will demonstrate a significant decrease in 
disruptive behaviors as assessed by the Disruptive Behavior Rating Scale (DBRS).   
 
III. Background and Rationale: Disruptive behavior disorders in children include conduct disorder, 
oppositional defiant disorder, and disruptive behavior disorder not otherwise specified. According to the 
Centers for Disease Control approximately 3.5% of US children have a diagnosable disruptive behavior 
disorder.13 Nearly 30% of children who present oppositional defiant behaviors develop a conduct disorder.14 
Those who present conduct problems between 7 to 9 years of age are at significantly elevated risk of poor 
outcomes in adulthood including higher likelihood of committing crime, substance dependence, mental 

AACAP Pilot Research Award Letter of Intent 
Andrea Diaz Stransky (Page 2) 
health problems and relationship difficulties, even after controlling for confounding factors.2 A sub-
population that is in higher need of treatment are children with ADHD. This is because nearly 50% of 
children with ADHD have co-occurring disruptive behavior disorders, and this worsens clinical prognosis.1,2  
The gold standard for prevention and treatment of behavioral problems in children is parent training, a 
systematic approach to help parents manage their children’s disruptive behaviors.15 Nevertheless, parent 
participation in in-person treatment is estimated between 10-34%, and those who enroll attend 35-50% of 
sessions.16 Parent-related barriers to participation include cost, schedule conflicts, transportation, need for 
child-care, and other competing family demands. Provider-related barriers include lack of trained staff, 
space and limited resources to provide families with parent training.17-19 Recent NIMH announcements 
have emphasized the priority of using technology to disseminate evidence-based practice.20 
In order to improve accessibility to evidence-based treatments, digital delivery of parent training 
interventions has been explored by several groups. A recent review of available digitally delivered 
interventions indicates that it is efficacious and demonstrates potential for increased accessibility among 
families of children with disruptive behaviors.8 To the best of our knowledge, only one other intervention 
provides individualized parent training to target the problem behaviors identified by parents.21 This protocol 
investigates a new model of DPT that is augmented with individualized goal-identification and clinical 
guidance with video-conferencing. In addition, the proposed program is the only one of its kind that can be 
accessed via mobile devices as well as on computers, which may further increase acceptability among 
parents.  A dose-adjustment component will not be tested in the proposed pilot trial. However, it will be an 
important element of the intervention in future trials, as it could help funnel the most severe cases to clinical 
settings and thus optimize use of resources.  It is necessary to conduct an open trial, without a comparison 
group initially, to establish acceptability and feasibility. If this pilot trial demonstrates acceptability and 
feasibility of online behavioral parent training with an integrated personalized component, it will provide the 
investigators preliminary data to apply for an NIMH grant to test this intervention in a larger Randomized 
Control Trial.  
 
IV. Research Plan 
Participants. In this pilot study, we will enroll 16 children with disruptive behaviors disorder recruited at 
Yale Health and Yale Medicine Pediatric Outpatient Services.  
Inclusion criteria: i. Child is ages 4 to 9 years old, ii. Child meets diagnostic criteria for one of the 
Disruptive Behavior Disorders or Disruptive Mood Dysregulation Disorder, iii. Parents have access to a 
mobile device and/or computer device, iv. Parents speak English as native language, v. Affective Reactivity 
Index parent-report score is above 3.6, which is the mean for children with severe irritability, vi. Families 
agree not to initiate new mental health treatments for the duration of this study. The sample will be enriched 
with children with ADHD, by ensuring that at least 50% of participants meet criteria for ADHD based on 
parent and teacher ratings above 1.8. 
Exclusion criteria: i. Child is non-verbal or minimally verbal; or ii. Child’s tantrums or aggressive behavior 
pose significant risk of injury or property damage and require immediate treatment; or iii. child has 
untreated medical or psychiatric disorder that requires immediate intervention; or iv. parents have 
previously received parent-training. 
Design This is an open, feasibility pilot study of interactive digital parent training for children with disruptive 
behaviors. iDPT is a novel web-based, interactive parenting intervention for disruptive behavior in children. 
Following the principles of testing feasibility and acceptability as the first step in developing new 
psychosocial interventions17, a comparison group will not be included in this pilot trial. Participants will be 
recruited through the Yale Health and Yale Medicine Pediatrics outpatient services. Parents who choose to 
enroll will undergo telephone screening, and if likely to be eligible, they will be invited to an in-person 

AACAP Pilot Research Award Letter of Intent 
Andrea Diaz Stransky (Page 3) 
clinical characterization visit. As an incentive to participate, parents will be offered $50 upon completion of 
in-person clinical characterization visit and $50 for attending final study visit, and parking compensation.   
Telephone Screening and Clinical Characterization. Screening and characterization will be 
conducted to ensure eligibility and establish a baseline for the Disruptive Behavior Rating Scale, the 
outcome measure. Parents who express interest in the study will be contacted by the lead clinician (the 
Principal Investigator). A brief description of the study will be provided, and eligibility will be determined 
based on the inclusion and exclusion criteria that do not require clinical assessment. If the subject is 
deemed likely to be eligible, they will be invited to attend an in-person clinical characterization assessment 
at the Yale Child Study Center Outpatient Clinic.  At the in-person characterization visit, a description of the 
study will be provided. Formal consent will be obtained from the parent and assent from the child. The 
Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version 
(K-SADS-PL)22, a structured interview will be conducted with parent and child by the Principal Investigator, 
to establish Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) diagnoses. The items, 
which are drawn directly from DSM-IV, are scored from 0 (never) to 3 (very often) and can be scored in two 
different ways: symptom count (number of items rated 2 or 3) and symptom severity (sum of the scores for 
the specific diagnostic subscale). Of interest in the current study are the following subscales: attention-
deficit/ hyperactivity disorder [ADHD; 18 items], oppositional defiant disorder [ODD; 8 items], pervasive 
developmental disorder [PDD; 12 items], and the 16-item anxiety scale.  In addition, parents will complete 
the Affective Reactivity Scale to select children whose disruptive behaviors are above 3.6, the mean for 
children with severe irritability.23,24  Parent and teacher scales of the Swanson, Nolan and Pelham 
Questionnaire (SNAP) will be used to ascertain ADHD diagnosis. This is to enrich the sample with 50% or 
more children with ADHD, a proportion of the sample that is reflective of prevalence in children with 
disruptive behaviors.24 In addition, the Child Symptom Inventory will be administered.  It is a 108-item 
parent report on child behavior.25 At this visit, the DBRS will be administered to ascertain eligibility and 
obtain a baseline of disruptive disorder symptom severity. Upon completion of the assessment, if the 
subject is deemed eligible to enroll in the study, parents will be provided with login and password to access 
the iDPT program. 
Intervention. The iDPT that will be utilized is on an online platform called MindNest Health. This 
platform is a parent-focused learning management system that was accepted into the Yale Entrepreneurial 
Institute Venture Creation Program. The iDPT program comprises 8 modules that closely adhere in content 
to evidence-based Parent Management Training (PMT. The digital platform has undergone comprehensive 
user testing with parents of children with disruptive behaviors to assess the software functioning. The 
content is delivered in parent-friendly and accessible language and the parent training principles are 
illustrated using animated simulations of a parent and child, with voice-over from a narrator.  A demo is 
available at https://dev.mindnesthealth.com/#/demo. The modules are delivered as follows: Weeks 1-2: 
The first two modules (“Introduction to tantrums” and “The ABC’s of Behavior”) provide background and 
foundational concepts of behavioral management.  After completion of module 2, parents will be scheduled 
for a 30-minute videoconference with the lead clinician to identify specific disruptive or noncompliant 
behaviors in their child that parents want to decrease.  Weeks 3-4:  Modules 3, 4, and 5 teach parents 
antecedent management skills.  Parents will be instructed to choose different skills, one skill at a time, to try 
out at home for 1 week, with clinician support via in-app messaging. After 2 weeks of practice, during 
videoconference #2, the lead clinician will address any barriers to implementation and instruct parents on 
tracking their child’s behaviors and progress.  Weeks 5-6:  Modules 6, 7, and 8 address reinforcement of 
positive behaviors.  Parents will be instructed to try out several reinforcement techniques for 2 weeks.  The 
final videoconference #3 will address barriers to implementation, goal tracking, and further instruction for 
continued implementation. 

AACAP Pilot Research Award Letter of Intent 
Andrea Diaz Stransky (Page 4) 
At the end of the study, participants will be asked to complete the Patient Satisfaction Questionnaire 
(PSQ)6, which is an 8-item measure of satisfaction with treatment. Parent and child versions are available, 
and both will be administered. Items such as “how satisfied were you with the treatment you have 
received?” and “would you recommend this treatment to a friend?” are rated on a 4-point scale with higher 
scores reflecting greater satisfaction. PSQ has excellent reliability and has been used in feasibility 
treatment studies of internet delivered behavioral interventions for pediatric populations.26,27  We predict 
(Hypothesis 1) that parent ratings of patient satisfaction with this iDPT will be high as evidenced by average 
score of 3.0 on the PSQ. In addition, families will complete the DBRS to assess post-intervention change in 
disruptive behaviors. If families wish to remain in contact for continuity of care, they will be referred to the 
Yale Child Study Center Outpatient Clinic for follow-up. 
 
Data Analysis: 1. Acceptability and Feasibility Analysis. Feasibility will be examined with three 
measures: a) completion of 80 or more of the modules and b) attendance to two of the three 
videoconferencing sessions. Parent’s perspective on acceptability of the intervention will be assessed 
utilizing the Patient Satisfaction Questionnaire. We will deem the treatment acceptable if parents select 
responses ‘Slightly Agree’ or ‘Agree’ on the 15 Acceptability factor items. This will be reflected as a score of 
3.0 or above on the PSQ. We will use fixed effects analysis of variance to compare session 
attendance/online course completion and scores on the PSQ.  2. Child Outcome. At baseline and 
endpoint, parents will complete the DBRS. We will compute pre-to post-treatment differences on the DBRS 
and examine the number of subjects showing clinically meaningful reduction in the DBRS total score. By 
convention, a DBRS score of 12 is considered clinically significant. A 35% reduction in DBRS score is 
considered “improved” and a 50% reduction is considered “much improved.”  Given that traditional parent-
training interventions show clinically significant improvement in approximately 60% of participants, we 
predict that 10 of 16 subjects in this open study (63%) will show a clinically meaningful reduction of the 
DBRS score. Because the primary aim of this study is to determine feasibility, the data analysis for the 
second aim of estimating the magnitude of change in the continuous outcome measure, DBRS, will be 
straightforward. We will use paired-samples t-test to examine the differences between baseline and 
endpoint DBRS scores.  Based on previous studies from our group23, we can project for a change from 
DBRS mean score of 15 (SD=5) at baseline to 10 (SD=5) and endpoint. This difference can be detected 
with statistical power > 80% and alpha level < 0.05 in a sample of 16 subjects.  
Feasibility:  Dr. Diaz Stransky, the principal investigator and lead clinician, is a Solnit adult and child 
psychiatry fellow at the Yale Child Study Center who will be in her Post-graduate year 5 of training. She has 
completed a course of training on PMT for child psychiatry fellows conducted by Dr. Sukhodolsky and has 
extensive experience of providing PMT to families of children with disruptive behavior.  Her research has 
been also focused on parent-training interventions aimed to improve child mental health. She is fluent in 
English, Spanish, Portuguese and French and could inform future versions of this program. Her mentors 
will be Dr. Denis Sukhodolsky and Dr. David Grodberg. The principal investigator will meet weekly with both 
mentors for supervision. Dr. Sukhodolsky is associate professor in the Yale Child Study Center and a 
licensed psychologist who has conducted large randomized control trials of parent-management training for 
disruptive behavior in children. Dr. Grodberg is a board-certified child psychiatrist, Director of the Yale Child 
Study Center Outpatient Clinic and founder of MindNest Health. Both mentors are trained to research 
fidelity in parent-management-training.  
Relevance to AACAP Pilot Award Mission:  The principal investigator is a talented young physician-scientist 
with significant protected research time, pursuing an academic career in this field. The intervention is an 
innovative solution that may help a major child mental health problem.  This study can provide the principal 
investigator with pilot data for a larger research award.  

AACAP Pilot Research Award Letter of Intent 
Andrea Diaz Stransky (Page 5) 
V. Project Timeline 
 
August 2018:  Recruitment and Screening will begin 
 
August 2018:   
- 
Participant enrollment will begin 
- 
Pre-intervention data collection will begin 
August 2018 – July 2019:  
- 
Intervention delivery for enrolled participants 
- 
Post-intervention data collection for participants after completing the intervention  
- 
Study team meetings will be held weekly with Principal Investigator and mentors 
May 2019:  
- 
Participant enrollment will stop at the end of May 
- 
Preliminary Data Analysis for New Research Poster submission 
July 2019: Last participants will complete intervention by the end of July 2019 
 
August-September 2019:  
- 
Data Analysis 
- 
Preparation of poster for presentation at annual meetings for AACAP, American Psychiatric 
Association, American Academy of Pediatrics. 
- 
Final report writing. 
- 
Preparation of grant proposal for NIMH funding. 
October 2019: AACAP Poster presentation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

AACAP Pilot Research Award Letter of Intent 
Andrea Diaz Stransky (Page 6) 
VI. Budget and Budget Justification 
Personnel:    Andrea Diaz Stransky, MD – (Principal Investigator, 40% effort) – Dr. Diaz Stransky is a 
PGY-4 Resident in a six-year Integrated Training Program in Adult Psychiatry, Child Psychiatry, and 
Research at the Yale Child Study Center (YCSC). As a PGY-5, Dr. Diaz Stransky will be funded on the 
Child Study Center’s institutional training grant T32 MH018268, which provides full-time stipend support 
and allows her to work on the research project(s) of her choice.  Dr. Diaz Stransky will carry out the 
baseline assessment of participants and provide videoconference sessions for all the participants. She will 
conduct the statistical analyses, interpret the results, write the manuscript, and present findings at national 
psychiatric meetings.      
    Denis Sukhodolsky, PhD (Primary Mentor) – Dr. Sukhodolsky is an Associate Professor at the YCSC 
and is the PI of an R01 study that uses cognitive-behavioral therapy to examine the neural circuitry of 
aggression in children across diagnostic categories. Dr. Sukhodolsky will oversee the intervention, 
including screening, videoconferencing and any other interactions with participants as the need arises. He 
will supervise the statistical data analysis, interpretation of results and preparation of the manuscript. As a 
mentor, there is no measurable effort provided. 
    David Grodberg, MD – (Secondary Mentor)- Dr. Grodberg is a board-certified Child and Adolescent 
Psychiatrist and serves as medical director of the YCSC Outpatient Clinic. He is the creator of the 
MindNest Health Platform.  He will provide mentorship and supervision to Dr. Diaz-Stransky. He will 
facilitate liaison between the research team and the MindNest Health team for any technology support or 
project management needs. As a mentor, there is no measurable effort. 
   To be named Postgraduate Associate – (Postgraduate Associate, 25% Effort) – The Postgraduate 
Associate will schedule in-person baseline and endpoint assessment visits, collect paper-and-pencil rating 
forms and enter data in the data-management system.  
Materials: Payment to participants for each visit considers $50 dollars per 15 participants for two visits, as 
well as additional visits by participants who attend the first visit but do not qualify for enrollment. In addition, 
$10 dollars per visit for parking will be included. The Child Symptom Inventory will be administered at the 
first visit and the Disruptive Behavior Rating Scale will be administered at each visit. Thus, one package of 
50 response sheets will be needed of each scale. 
 
PERSONNEL 
Name 
Role on Project 
% Time  
Salary 
Request Fringe Benefits 
Amount 
Requested 
Andrea Diaz 
Stransky  
Principal Investigator 
40 % 
$0 
$0 
Not allowed $0 
Denis Sukhodolsky  
Primary Mentor 
0 % 
$0 
$0 
$0 
David Grodberg 
Secondary Mentor 
0 % 
$0 
$0 
$0 
To Be Named  
Post Grad Associate 
25% 
$9,500 
$2,898 
$12,398 
 
 
 
 
SUBTOTAL 
$12,398 
MATERIALS 
Description 
Quantity 
Unit Cost 
Amt. Requested 
(DBRS-1) Disruptive Behavior Rating Scale Kit  
1 
$ 208  
$ 208 
(DBRS-3) Parent Version Response Forms  
1 package (50) 
$35 
$ 35 
Child Symptom Inventory 
1 package (50) 
$63 
$ 63 
Study payment for each session 
33 
$60 
$1980 
AACAP Travel Expenses 
 
 
$316 
 
 
 
 
GRAND TOTAL 
$15,000 

AACAP Pilot Research Award Letter of Intent 
Andrea Diaz Stransky (Page 7) 
VII. Exclusion of Women and Minorities 
 
This protocol does not exclude women or minorities from the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

AACAP Pilot Research Award Letter of Intent 
Andrea Diaz Stransky (Page 8) 
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