Tantrum Tamers 2.0: The Role of Emotion

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Child Behavior, Attention Deficit and Disruptive Behavior Disorders, Problem Behavior

Intervention / Treatment
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* Behavioral: Helping the Noncompliant Child (HNC)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Helping the NonCompliant Child Treatment<br>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)<br>* HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity | 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. | Baseline, study completion, approximately 10 weeks total | 
| Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem | 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. | Baseline, study completion, approximately 10 weeks total | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Difficulties With Emotion Regulation Scale (DERS) Score | 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. | Baseline, study completion, approximately 10 weeks total | 
| Change in Coping With Children's Negative Emotions Scale Score | 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. | Baseline, study completion, approximately 10 weeks total | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tantrums, Inattentive, Noncompliance