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Tantrum Tamers 2.0: The Role of Emotion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03597789
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : November 1, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in Eyberg Child Behavior Inventory (ECBI) Score [ Time Frame: Baseline through study completion, an average of 11 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Difficulties with Emotion Regulation Scale (DERS) Score [ Time Frame: Baseline through study completion, an average of 11 weeks ]
    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. The DERS has high internal consistency, good test-retest reliability, adequate construct and predictive validity and is sensitive to change over time .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597789


Contacts
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Contact: Deborah Jones, PhD 919-962-3995 djjones@email.unc.edu
Contact: Patrick Turner, BA 919-843-2351 pturner@unc.edu

Locations
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United States, North Carolina
UNC Department of Psychology & Neuroscience Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Patrick Turner, BA    919-843-2351    pturner@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Deborah Jones, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03597789    
Other Study ID Numbers: 18-1040
1R21MH113887-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: 9 to 36 months following publication of primary study results

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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:
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Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Behavioral Symptoms