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Completed

NCT Number: NCT03597789

Tantrum Tamers 2.0: The Role of Emotion

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.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Department of Psychology & Neuroscience

Chapel Hill, North Carolina, 27599, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Helping the Noncompliant Child (HNC)

Behavioral

HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.

Primary outcomes

  1. Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in Difficulties With Emotion Regulation Scale (DERS) Score

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

The Role of Emotion Regulation and Socialization in Behavioral Parent Training (BPT) Efficiency and Outcomes

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2018
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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