Back to resultsTantrum Tamers 2.0: The Role of Emotion
Primary Purpose
Child Behavior, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helping the Noncompliant Child (HNC)
Sponsored by
About this trial
This is an interventional treatment trial for Child Behavior focused on measuring Tantrums, Inattentive, Noncompliance
Eligibility Criteria
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)
Sites / Locations
- UNC Department of Psychology & Neuroscience
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Helping the NonCompliant Child Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03597789
First Posted
June 29, 2018
Last Updated
August 23, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03597789
Brief Title
Tantrum Tamers 2.0: The Role of Emotion
Official Title
The Role of Emotion Regulation and Socialization in Behavioral Parent Training (BPT) Efficiency and Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
Keywords
Tantrums, Inattentive, Noncompliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Helping the NonCompliant Child Treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Helping the Noncompliant Child (HNC)
Intervention Description
HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.
Primary Outcome Measure Information:
Title
Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity
Description
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.
Time Frame
Baseline, study completion, approximately 10 weeks total
Title
Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem
Description
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.
Time Frame
Baseline, study completion, approximately 10 weeks total
Secondary Outcome Measure Information:
Title
Change in Difficulties With Emotion Regulation Scale (DERS) Score
Description
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.
Time Frame
Baseline, study completion, approximately 10 weeks total
Title
Change in Coping With Children's Negative Emotions Scale Score
Description
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.
Time Frame
Baseline, study completion, approximately 10 weeks total
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Jones, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Department of Psychology & Neuroscience
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34533656
Citation
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.
Results Reference
derived
PubMed Identifier
34378434
Citation
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.
Results Reference
derived
PubMed Identifier
33900099
Citation
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.
Results Reference
derived
PubMed Identifier
33622517
Citation
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.
Results Reference
derived
Learn more about this trial
Tantrum Tamers 2.0: The Role of Emotion
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