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
|Condition or disease||Intervention/treatment||Phase|
|Child Behavior Attention Deficit and Disruptive Behavior Disorders Problem Behavior||Behavioral: Helping the Noncompliant Child (HNC)||Not Applicable|
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 (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)|
|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|
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.
- 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.
- 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 .
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
|Contact: Deborah Jones, PhDfirstname.lastname@example.org|
|Contact: Patrick Turner, BAemail@example.com|
|United States, North Carolina|
|UNC Department of Psychology & Neuroscience||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Patrick Turner, BA 919-843-2351 firstname.lastname@example.org|
|Principal Investigator:||Deborah Jones, PhD||University of North Carolina, Chapel Hill|