Tantrum Tamers 2.0: The Role of Emotion

Not Applicable

Completed

• Conditions: Problem Behavior; Child Behavior; Attention Deficit and Disruptive Behavior Disorders
• Interventions: Behavioral: Helping the Noncompliant Child (HNC)

• Registration Number: NCT03597789
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-24
• Study Start: 2018-11-01
• Primary Completion: 2020-11-02
• Study Completion: 2020-11-02
• Status Verified: 2021-07
• Results First Submitted: 2021-07-20
• Results First Submitted QC: 2021-07-20
• Results First Posted: 2021-08-16
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Clinically significant child problem behavior

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Helping the NonCompliant Child Treatment	Helping the Noncompliant Child (HNC)	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

UNC Department of Psychology & Neuroscience; 🇺🇸 Chapel Hill, North Carolina, United States