Tantrum Tamers 2.0: The Role of Emotion

NCT03597789 | Completed Results

• 2 other identifiers: 18-10401R21MH113887-01A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Problem Behavior

Keywords

Tantrums; Inattentive; Noncompliance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Difficulties With Emotion Regulation Scale (DERS) Score

  Baseline, study completion, approximately 10 weeks total

• Change in Coping With Children's Negative Emotions Scale Score

  Baseline, study completion, approximately 10 weeks total

Study Arms (1)

Helping the NonCompliant Child Treatment

OTHER

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)

Interventions

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.

Helping the NonCompliant Child Treatment

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Clinically significant child problem behavior

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UNC Department of Psychology & Neuroscience

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

• McKee LG, Yang Y, Highlander A, McCall M, Jones DJ. Conceptualizing the Role of Parent and Child Emotion Regulation in the Treatment of Early-Onset Behavior Disorders: Theory, Research, and Future Directions. Clin Child Fam Psychol Rev. 2023 Mar;26(1):272-301. doi: 10.1007/s10567-022-00419-y. Epub 2022 Nov 17.

  PMID: 36385585 DERIVED

• Highlander AR, Jones DJ. Integrating Objective and Subjective Social Class to Advance Our Understanding of Externalizing Problem Behavior in Children and Adolescents: A Conceptual Review and Model. Clin Child Fam Psychol Rev. 2022 Jun;25(2):300-315. doi: 10.1007/s10567-021-00369-x. Epub 2021 Sep 17.

  PMID: 34533656 DERIVED

• Highlander A, Zachary C, Jenkins K, Loiselle R, McCall M, Youngstrom J, McKee LG, Forehand R, Jones DJ. Clinical Presentation and Treatment of Early-Onset Behavior Disorders: The Role of Parent Emotion Regulation, Emotion Socialization, and Family Income. Behav Modif. 2022 Sep;46(5):1047-1074. doi: 10.1177/01454455211036001. Epub 2021 Aug 11.

  PMID: 34378434 DERIVED

• Loiselle R, Parent J, Georgeson AR, Thissen D, Jones DJ, Forehand R. Validation of the Multidimensional Assessment of Parenting: An application of item response theory. Psychol Assess. 2021 Sep;33(9):803-815. doi: 10.1037/pas0001019. Epub 2021 Apr 26.

  PMID: 33900099 DERIVED

• Jones DJ, Loiselle R, Zachary C, Georgeson AR, Highlander A, Turner P, Youngstrom JK, Khavjou O, Anton MT, Gonzalez M, Bresland NL, Forehand R. Optimizing Engagement in Behavioral Parent Training: Progress Toward a Technology-Enhanced Treatment Model. Behav Ther. 2021 Mar;52(2):508-521. doi: 10.1016/j.beth.2020.07.001. Epub 2020 Jul 15.

  PMID: 33622517 DERIVED

MeSH Terms

Conditions

Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Problem Behavior; Patient Compliance

Condition Hierarchy (Ancestors)

Behavior; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Deborah Jones, PhD
• Organization: University of North Carolina at Chapel Hill

djjones@email.unc.edu

919-962-5082

Study Officials

• Deborah Jones, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 24, 2018
• Study Start: November 1, 2018
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: September 16, 2021
• Results First Posted: August 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication of primary study results

Locations

US (1)