Clinical trial NCT03597789: Tantrum Tamers 2.0: The Role of Emotion
Official title: The Role of Emotion Regulation and Socialization in Behavioral Parent Training (BPT) Efficiency and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Attention Deficit and Disruptive Behavior Disorders
Problem Behavior
Keywords: Tantrums
Inattentive
Noncompliance
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-07-24
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All families get the evidence-based treatment, Helping the Noncompliant Child (HNC)
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Change in Eyberg Child Behavior Inventory (ECBI) Score-Intensity
timeFrame: Baseline, study completion, approximately 10 weeks total
measure: Change in Eyberg Child Behavior Inventory (ECBI) Score-Problem
timeFrame: Baseline, study completion, approximately 10 weeks total
Secondary outcomes:
measure: Change in Difficulties With Emotion Regulation Scale (DERS) Score
timeFrame: Baseline, study completion, approximately 10 weeks total
measure: Change in Coping With Children's Negative Emotions Scale Score
timeFrame: Baseline, study completion, approximately 10 weeks total
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Department of Psychology & Neuroscience
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Deborah Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.