Tantrum Tamers 2.0: The Role of Emotion

The Role of Emotion Regulation and Socialization in Behavioral Parent Training (BPT) Efficiency and Outcomes

This study aims to better understand how to best help parents of young children with problem behavior. Problem behaviors vary between and within children, but can include inattention/hyperactivity, tantrums, and/or noncompliance.

Study Overview

• Status: Completed
• Conditions: Problem Behavior; Attention Deficit and Disruptive Behavior Disorders; Child Behavior
• Intervention / Treatment: Behavioral: Helping the Noncompliant Child (HNC)

Detailed Description

If eligible and choose to participate, this study includes:

A baseline assessment which will include asking a series of questions about parent, child and family, as well as parent-child observations.

If eligible for treatment, sessions occur once per week for approximately 8 to 12 weeks. Sessions include new information and lots of practice and discussion about how to make the skills work best for specific families.

After finishing treatment a post-assessment (similar to BL) conducted.

All of the assessments (i.e., video-and audio-recorded), as well as the sessions with a therapist will be recorded (i.e., video recorded).

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Department of Psychology & Neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinically significant child problem behavior

Exclusion Criteria:

• Current severe symptoms in parent or child that would prohibit participation (e.g., parent current psychotic or substance use disorder)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Helping the NonCompliant Child Treatment; Families will participate in an average of 8 to 12 weeks of Behavioral Parent Training (BPT), by way of the standard-of-care training program "Helping the Noncompliant Child" (HNC) via weekly sessions and mid-week calls.	Behavioral: Helping the Noncompliant Child (HNC); HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity	The ECBI is a 36 item parent-report scale. For each item, parents rate the intensity of the behavior (0 = never to 7 = always) and whether they consider each behavior to be a problem (0 = no; 1 = yes). Clinically significant symptoms are defined by scores more than 2 standard deviations above the normed mean for the Intensity Subscale (clinical cutoff = 127) and/or Problem Subscale (clinical cutoff = 11) Scales. Intensity scores range from 36 to 252. A mean score decrease indicates a reduction in parent perception of the intensity of the problem behavior.	Baseline, study completion, approximately 10 weeks total
Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem	The ECBI is a 36 item parent-report scale. For each item, parents rate the intensity of the behavior (0 = never to 7 = always) and whether they consider each behavior to be a problem (0 = no; 1 = yes). Clinically significant symptoms are defined by scores more than 2 standard deviations above the normed mean for the Intensity Subscale (clinical cutoff = 127) and/or Problem Subscale (clinical cutoff = 11) Scales. The number of "yes" responses are counted and averaged. Problem scores range from 0 to 36. A mean score decrease indicates a reduction in parent perception of the number of the problem behaviors.	Baseline, study completion, approximately 10 weeks total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Difficulties With Emotion Regulation Scale (DERS) Score	The Difficulties in Emotion Regulation Scale (DERS) will be used as the measure of caregiver's emotion dysregulation. The 36-item DERS yields a composite total score as well as scores for the following subscales: 1) Nonacceptance Subscale, non-acceptance of negative emotions; 2) Goal Subscale, difficulties in engaging in goal-directed behaviors when experiencing negative emotions, 3) Impulse Subscale, impulse control difficulties; 4) Strategies Subscale, limited access to emotion regulation strategies; 5) Awareness Subscale, lack of emotional awareness; and 6) Clarity Subscale, lack of emotional clarity. DERS total scores range from 36 to 180. The composite total is reported for this small sample size. A mean score decrease indicates a reduction in parent difficulties with emotion regulation.	Baseline, study completion, approximately 10 weeks total
Change in Coping With Children's Negative Emotions Scale Score	The Coping with Children's Negative Emotions Scale (CCNES) assesses the ways that parents cope with their children's distress and negative emotions. Participants use a 7-point Likert scale where 7 indicates high levels of specific parenting behavior (i.e. supportive and non-supportive parenting behavior). Scores are reported condensing 6 categories into 2 broader domains (supportive/non-supportive) with scores ranging from 1 to 21. Assessed at Baseline and end of study. A mean score decrease in non-supportive scores reflects an improvement in parents' non-supportive strategies and a mean score increase in the supportive score indicates improvement in parents' supportive strategies.	Baseline, study completion, approximately 10 weeks total

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Deborah Jones, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Highlander AR, Jones DJ. Integrating Objective and Subjective Social Class to Advance Our Understanding of Externalizing Problem Behavior in Children and Adolescents: A Conceptual Review and Model. Clin Child Fam Psychol Rev. 2022 Jun;25(2):300-315. doi: 10.1007/s10567-021-00369-x. Epub 2021 Sep 17.
• Highlander A, Zachary C, Jenkins K, Loiselle R, McCall M, Youngstrom J, McKee LG, Forehand R, Jones DJ. Clinical Presentation and Treatment of Early-Onset Behavior Disorders: The Role of Parent Emotion Regulation, Emotion Socialization, and Family Income. Behav Modif. 2022 Sep;46(5):1047-1074. doi: 10.1177/01454455211036001. Epub 2021 Aug 11.
• Loiselle R, Parent J, Georgeson AR, Thissen D, Jones DJ, Forehand R. Validation of the Multidimensional Assessment of Parenting: An application of item response theory. Psychol Assess. 2021 Sep;33(9):803-815. doi: 10.1037/pas0001019. Epub 2021 Apr 26.
• Jones DJ, Loiselle R, Zachary C, Georgeson AR, Highlander A, Turner P, Youngstrom JK, Khavjou O, Anton MT, Gonzalez M, Bresland NL, Forehand R. Optimizing Engagement in Behavioral Parent Training: Progress Toward a Technology-Enhanced Treatment Model. Behav Ther. 2021 Mar;52(2):508-521. doi: 10.1016/j.beth.2020.07.001. Epub 2020 Jul 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): November 2, 2020
• Study Completion (ACTUAL): November 2, 2020

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (ACTUAL): July 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Inattentive; Tantrums; Noncompliance
• Additional Relevant MeSH Terms: Behavioral Symptoms; Neurodevelopmental Disorders; Problem Behavior; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: 18-1040; 1R21MH113887-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication of primary study results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No