The Role of Emotion Regulation and Socialization in Behavioral Parent Training (BPT) Efficiency and Outcomes
Phase: NA
Conditions: Child Behavior, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
Sponsor: University of North Carolina, Chapel Hill

 
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The Role of Emotion Regulation and Socialization in BPT Efficiency and Outcomes 
 
   NCT number NCT03597789 
Document Date 06/24/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Complete Title:   
 
The Role of Emotion Regulation and Socialization in BPT Efficiency and Outcomes  
 
Short Title:   
 
 
Tantrum Tamers 2.0: The Role of Emotion 
 
Clinical Trials Identifier:  
NCT03597789 
 
Drug or Device Name(s): 
N/A 
 
FDA IND/IDE (if applicable): 
N/A 
 
Sponsor: 
 
 
University of North Carolina at Chapel Hill 
 
Protocol Date:  
 
June 24, 2021 
 
 
 
 
Sponsor : 
University of North Carolina at Chapel Hill 
104 Airport Drive 
Suite 220 
Campus Box 1350 
Chapel Hill, NC 27599 
 
Study Principal Investigator: 
Deborah J. Jones, Ph.D. 
Department of Psychology and Neuroscience 
UNC Chapel Hill 
Chapel Hill, NC 27599-3270  
Phone: 919-962-3995 
email: djjones@email.unc.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
Table of Contents ................................................................................................................. 3 
Abbreviations and Definitions of Terms ................................................................................ 4 
Protocol Synopsis .............................................................................................................. 5-6 
1 
BACKGROUND  AND RATIONALE .......................................................................................................................... 7 
2 
STUDY OBJECTIVES ................................................................................................................................................ 7 
3 
INVESTIGATIONAL PLAN .................................................................................................................................... 7-8 
4 
STUDY PROCEDURES .......................................................................................................................................... 8-9 
5 
STUDY EVALUATIONS AND MEASUREMENTS ..................................................................................................... 9 
6 
STATISTICAL CONSIDERATIONS ............................................................................................................................ 9 
7 
STUDY INTERVENTION (DEVICE OR OTHER INTERVENTION) ......................................................................... 9-10 
8 
STUDY INTERVENTION ADMINISTRATION ......................................................................................................... 10 
9 
SAFETY MANAGEMENT ....................................................................................................................................... 10 
10  DATA COLLECTION AND MANAGEMENT ............................................................................................................ 10 
11 RECRUITMENT STRATEGY ................................................................................................................................... 10 
12 CONSENT PROCESS ............................................................................................................................................. 10 
13 PUBLICATION ....................................................................................................................................................... 10 
14 REFERENCES ........................................................................................................................................................ 10 
Appendix ............................................................................................................................................................. 11 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation 
Definition 
BD 
Behavior Disorder 
BPT 
Behavioral Parent Training 
ER 
Emotion Regulation 
ES 
Emotion Socialization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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PROTOCOL SYNOPSIS 
Study Title 
Tantrum Tamers 2.0: The Role of Emotion 
Funder 
National Institute of Mental Health (R21MH113887) 
Clinical Phase 
N/A 
Study Rationale 
There is variability in standard of care Behavioral Parent Training (BPT) 
outcomes for early- onset (3 to 8 y.o.) Behavior Disorders (BDs), 
suggesting yet unidentified causal mechanisms. One candidate, emotion 
regulation (ER), has been implicated in the development of early-onset 
BDs. This study explores ER in the context of BPT.  
Study Objective(s) 
Primary  
Describe child behavior and emotion regulatory processes in BPT. 
Secondary 
Use preliminary results to inform future research on BPT adaptations. 
Test Article(s) 
(If Applicable) 
N/A 
Study Design 
 
Single-arm, open trial of Behavioral Parent Training (BPT) for early-onset 
behavior disorders (BDs)  
Subject Population 
key criteria for Inclusion 
and Exclusion: 
Inclusion Criteria 
1. 3-8 year old child  
2. Parent is legal guardian 
3. Child has clinically significant problem behavior 
4. English-speaking 
Exclusion Criteria 
1. Parent current mood, psychotic, substance use disorder 
2. Current involvement child protective services 
3. Child developmental/physical disability precludes BPT 
Number Of Subjects  
 
45  
Study Duration 
Each family: Approximately 12 weeks  
 All families:  Approximately 2 years   
Study Phases 
Screening 
Study Treatment 
Follow-Up   
 (1) Screening/Baseline: screening to determine eligibility and obtain 
consent and (2) Intervention: study intervention; 3) Post-assessment:  
repeat baseline measures. 
Efficacy Evaluations 
N/A 
Pharmacokinetic 
Evaluations 
N/A 
Safety Evaluations 
N/A 

 
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Statistical And Analytic 
Plan 
Given pilot nature of study and small sample size, trends in the data will 
be examined, including means and standard deviations.  
DATA AND SAFETY 
MONITORING PLAN 
Dr. Jones responsible for data and safety monitoring.  No data or safety 
issues emerged, but would have been/will be discussed with IRB and 
NIMH. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1 
BACKGROUND AND RATIONALE 
 
 
1.1 
Introduction:  
 
Eight-million (16%) U.S. children have a Behavior Disorder (BD), which is linked to a ten-fold increase in education, 
health care, and criminal justice costs. Early intervention is thus critical, yet outcomes for the standard of care, 
Behavioral Parent Training (BPT), vary suggesting the likelihood of a yet to be identified underlying mechanism. 
One likely candidate, emotion regulation (ER), has been implicated in a broad range of adult and child outcomes, 
including early-onset BDs. For example, parental difficulties with ER, as well as difficulties helping children to 
navigate and regulate emotion (i.e., emotion socialization), are linked to the etiology, maintenance, and severity 
of early-onset BDs. As such, this NIMH Exploratory and Developmental Research Grant (Parent R21) aims to 
further explore the ER in the context of BPT process and outcomes.  
 
1.2 
Name and Description of Investigational Product or Intervention: 
 
Behavioral Parent Training (BPT) is the well-established, standard of care treatment for early-onset BDs.  Both a 
parent and the target child attend sessions which focus on parents learning, practicing and effectively using new 
skills to manage child behavior.  Phase I skills focus on teaching parents to provide positive attention to behaviors 
they want to increase and Phase II focuses on improving child compliance by using effective and consistent 
consequences for noncompliance. Treatment is an average of 8-12 weeks. This study is exploring the mechanisms 
underlying BPT. 
 
1.3 
Non-Clinical and Clinical Study Findings:  
 
BPT is the recommend first line of treatment and standard of care for early-onset BDs. Therefore, the probability 
and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those 
ordinarily encountered if families were seeking psychological services in the community. In turn, the benefit of 
improving child behavior outweigh risks.  
 
1.4 
Relevant Literature and Data:  
 
This is a pilot study, so it will serve as preliminary data for future work. 
 
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STUDY OBJECTIVE  
 
2.1 
Primary Objective:  
 
Describe patterns of child behavior and emotion regulatory processes in BPT. 
 
2.2 
Secondary Objective:   
 
Use preliminary results to inform future research on BPT adaptations. 
 
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INVESTIGATIONAL PLAN (brief overview) 
 
3.1 
Study Design:  
 
Single-arm, open trial of Behavioral Parent Training (BPT) for early-onset behavior disorders (BDs).  
Study phases: Screening/Baseline, Treatment, Post-treatment.  
 

 
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3.2 
Allocation to Treatment Groups and Blinding (if applicable):  
 
N/A 
 
3.3 
Study Duration, Enrollment and Number of Subjects:  
 
N = 45 children;  
Each child participates in BPT treatment with a parent for an average of 10 weeks (M = 8 to 12);  
Total study time with screening and post-treatment assessment approximately 12 weeks/family. 
 
3.4 
Study Population:  
 
Inclusion Criteria: 3-8 year old child; Parent legal guardian; Child meets criteria for clinically significant problem 
behavior; English-speaking.  
 
Exclusion Criteria: Parent has current mood, psychotic, substance use disorder; Current involvement child 
protective services; Child has developmental/physical disability that precludes BPT 
 
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STUDY PROCEDURES  
 
4.1 
Screening/Baseline Visit procedures:   
 
Interested families contact study coordinator to determine elibility and, if eligible, are scheduled for a baseline 
assessment to assess primary other study variables.   
 
4.2 
Intervention/Treatment procedures (by visits):   
 
Both a parent and the target child attend sessions which  focus on parents learning, practicing and effectively 
 
using new skills to manage child behavior.  Phase I skills focus on teaching parents to provide positive attention to 
 
behaviors they want to increase and Phase II focuses on  improving child  compliance by using effective and 
 
consistent consequences for noncompliance. Sessions recorded for therapist supervision and study purposes.   
 
4.2 
Follow- up procedures (by visits):   
 
Screening/baseline measures repeated at treatment completion.  
 
4.3 
Unscheduled visits:  
 
N/A 
 
4.4 
Concomitant Medication documentation:  
 
N/A 
 
4.5 
Rescue medication administration ( if applicable):  
 
N/A 
 
4.6 
Subject Completion/ Withdrawal procedures: Completion determined by parent meeting established BPT 
skill mastery criteria.  Parents unable to continue with treatment (e.g., moving), referred for other 
services/providers when possible.  

 
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4.7 
Screen failure procedures:   
 
Ineligible families referred to local providers who provide BPT (or other relevant psychological treatment for 
children).  
 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
 
5.1 
Efficacy Evaluation ( if applicable):  
 
N/A 
 
5.2 
Pharmacokinetic Evaluation ( if applicable):  
 
N/A 
 
5.3 
Safety Evaluations:  
 
N/A 
 
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STATISTICAL CONSIDERATION 
    
6.1 
Primary Endpoint:  
 
Eyberg Child Behavior Inventory (ECBI; Eyberg & Pincus, 1999) 
 
6.2 
Secondary Endpoint:  
 
Difficulties with Emotion Regulation Scale (DERS;  Gratz & Roemer, 2004) 
Coping with Children’s Negative Emotions Scale (CCNES; Fabes et al., 2002) 
 
6.2 
Statistical Methods:  
 
Given the pilot nature of the study and small sample size, trends in the data are focus of analyses, including 
means and standard deviations for aforementioned measures.  
 
6.3 
Sample Size and Power:  
 
This is a pilot study with insufficient sample size and power to achieve statistical significance.  Trends examined to 
inform sample size to achieve adequate power in future work.   
 
6.4 
Interim Analysis:  
 
N/A 
 
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STUDY INTERVENTION (drug, device or other intervention details) 
 
Behavioral Parent Training is the recommend first line of treatment and standard of care for early-onset BDs. Both 
 
a parent and the target child attend sessions which focus on parents learning, practicing and effectively using new 
 
skills to manage child behavior.  Phase I skills focus on teaching parents to provide positive attention to behaviors 

 
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they want to increase and Phase II focuses on improving child compliance by using effective and consistent 
 
consequences for noncompliance.  
 
8 
STUDY INTERVENTION ADMINISTRATION (if applicable)  
 
Single-arm, open trial of well-established, evidence-based intervention (BPT), so no randomization or blinding. 
 
9 
SAFETY MANAGEMENT 
 
 
Data safety monitored throughout course of study (see Data Collection and Management).  
 
Given that BPT is a well-established intervention, Adverse Events extremely unlikely.  
 
No Adverse Events occurred. 
 
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DATA COLLECTION AND MANAGMENT  
 
• 
All families assigned study identification number (Family ID).   
• 
Identifying information maintained for contacting families for study purposes only. 
• 
Identifying information stored separately from study data, which is coded by Family ID. 
• 
Study data stored on password protected server with 2-step verification and limited to study staff. 
• 
All hard copies stored in locked, passcode protected laboratory space.     
  
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RECRUITMENT STRATEGY 
 
Families recruited from local community and agencies serving young children.  
Methods included flyers, advertisements, and word-of-mouth.   
Interested families contact study coordinator to do initial elibigility screen.  
 
12  CONSENT PROCESS 
 
 
 
Parental consent for self and child at baseline assessment.  
 
Consent included a description of study procedures, benefits, and risks.  
 
Assessor also reviewed consent with parent and addressed any questions/provided additional information . 
 
13  PLANS FOR PUBLICATION 
 
Given preliminary nature of data, results will be published in a primary outcomes paper (e.g., brief report) as well 
as serve as pilot data for a subsequent grant. 
 
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REFERENCES 
 
Eyberg, S.M., & Pincus, D. (1999). Eyberg Child Behavior Inventory and Sutter-Eyberg Student Behavior Inventory-
 
Revised: Professional Manual. Odessa, FL: Psychological  Assessment Resources. 
Fabes, R. A., Poulin, R. E., Eisenberg, N., Madden-Derdich, D. A. (2002).  The Coping with Children's Negative  
 
 
Emotions Scale (CCNES): Psychometric properties and relations with children's emotional  
 
 
 
competence.  Marriage  & Family Review, 34(3-4), 285-310.  
 
Gratz, K. L. & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation:   
 
 
Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale.  
 
 
Journal of Psychopathology and Behavioral Assessment, 26, 41-54.  
 

 
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15      APPENDIX 
N/A