Tantrum Tamers 2.0: The Role of Emotion

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT03597789
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 45
• Location: 1
• Arm: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Problem Behavior	Behavioral: Helping the Noncompliant Child (HNC)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Role of Emotion Regulation and Socialization in Behavioral Parent Training (BPT) Efficiency and Outcomes
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Nov 2, 2020
• Actual Study Completion Date: Nov 2, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity [Baseline, study completion, approximately 10 weeks total]

   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.

2. Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem [Baseline, study completion, approximately 10 weeks total]

   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

1. Change in Difficulties With Emotion Regulation Scale (DERS) Score [Baseline, study completion, approximately 10 weeks total]

   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.

2. Change in Coping With Children's Negative Emotions Scale Score [Baseline, study completion, approximately 10 weeks total]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC Department of Psychology & Neuroscience	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Deborah Jones, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 24, 2021

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03597789
• Other Study ID Numbers: 18-1040; 1R21MH113887-01A1
• First Posted: Jul 24, 2018
• Last Update Posted: Sep 16, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of North Carolina, Chapel Hill: Tantrums; Inattentive; Noncompliance
• Additional relevant MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders

Study Results

Participant Flow

Arm/Group Title	Helping the NonCompliant Child Treatment
Arm/Group Description	Families will participate in approximately 10 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. 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.
Period Title: Overall Study
STARTED	45
COMPLETED	10
NOT COMPLETED	35

Baseline Characteristics

Arm/Group Title	Helping the NonCompliant Child Treatment
Arm/Group Description	Families will participate in approximately 10 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. 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.
Overall Participants	45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.83 (1.15)
Sex: Female, Male (Count of Participants)
Female	24 53.3%
Male	21 46.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	45 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 4.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 2.2%
White	36 80%
More than one race	6 13.3%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	45 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Helping the NonCompliant Child Treatment
Arm/Group Description	Families will participate in approximately 10 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. 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.
Measure Participants	35
Mean (Full Range) [score on a scale]	-45.46

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Helping the NonCompliant Child Treatment
Arm/Group Description	Families will participate in approximately 10 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. 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.
Measure Participants	35
Mean (Full Range) [score on a scale]	-9.37

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Helping the NonCompliant Child Treatment
Arm/Group Description	Families will participate in approximately 10 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. 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.
Measure Participants	35
Mean (Full Range) [score on a scale]	-1.11

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Helping the NonCompliant Child Treatment
Arm/Group Description	Families will participate in approximately 10 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. 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.
Measure Participants	35
Supportive	0.45
Non-Supportive	-1.06

Adverse Events

Time Frame	From the time of Informed Consent through post assessment visit, an approximate total of 10 weeks.
Arm/Group Title	Helping the NonCompliant Child Treatment
Arm/Group Description	Families will participate in approximately 10 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. 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.
All Cause Mortality
	Helping the NonCompliant Child Treatment
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Serious Adverse Events
	Helping the NonCompliant Child Treatment
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	Helping the NonCompliant Child Treatment
	Affected / at Risk (%)	# Events
Total	0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.