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Clinical Trials/NCT03597789
NCT03597789
Completed
Not Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country45 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Behavior
Sponsor
University of North Carolina, Chapel Hill
Enrollment
45
Locations
1
Primary Endpoint
Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
November 2, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Change in Coping With Children's Negative Emotions Scale Score(Baseline, study completion, approximately 10 weeks total)
  • Change in Difficulties With Emotion Regulation Scale (DERS) Score(Baseline, study completion, approximately 10 weeks total)

Study Sites (1)

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