Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions (HNC-EC)

April 29, 2021 updated by: Lynn Fainsilber Katz, University of Washington
The proposed research will focus on the development of a brief emotion-coaching (EC) parenting program (which directly targets child emotion awareness/recognition and affective empathy), that will be combined with a well-established parent management training program (Helping the Noncompliant Child; HNC) for treating oppositional defiant disorder (ODD) in children who also have limited prosocial emotions (e.g., lack of guilt and empathy, callous use of others).

Study Overview

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child with oppositional defiant disorder and low prosocial emotions

Exclusion Criteria:

  • Unable to speak/understand English
  • Significant developmental delay or autism spectrum disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parent Training plus Emotion Coaching
This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting intervention.
This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting program.
Active Comparator: Parent Training Only
This intervention will consist of a parent management training program called Helping the Noncompliant Child.
This intervention will consist of a parent management training program called Helping the Noncompliant Child.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eyberg Child Behavior Inventory - intensity score
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Child conduct problems at baseline, mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Early Childhood Inventory-4 ODD scale
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Change in child conduct problems for children ages 3-5 at baseline, mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Child Symptom Inventory-IV
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Child conduct problems for children ages 6-7 at baseline, mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Behavioral Coding System - percent child inappropriate behaviors
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Child inappropriate behaviors at baseline, mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Behavioral Coding System percent child compliance
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Child compliance at baseline, mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inventory of Callous-Unemotional Traits - preschool version - total score
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Callous-unemotional traits at baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
A Developmental Neuropsychological Assessment (NEPSY-II) Affect Recognition Task - fear recognition
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Affect recognition at baseline, mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
NEPSY-II Affect Recognition Task - sadness recognition
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Affect recognition in baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Griffith Empathy Measure - empathy score
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Empathy at baseline and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Behavioral coding of Zahn-Waxler empathy paradigm - amount of attention, affective response congruent with examiner, concern for others, disregard for others
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Empathy at baseline and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Behavioral Coding System - positive attention rate per minute
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting behavior - positive attention at baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Behavioral Coding System - total commands rate per minute
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Change in parenting behavior - commands at baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting scale - overactivity
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting at baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting scale - laxness
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting at baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parent Meta-Emotion Interview emotion coaching scale
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Emotion coaching at baseline and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting Sense of Competence satisfaction scale
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting satisfaction at baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting Sense of Competence efficacy scale
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Parenting efficacy at baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulties with Emotion Regulation Scale - lack of awareness and limited access to emotion regulation strategies
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Maternal emotion regulation abilities at baseline mid-treatment and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Beck Depression Inventory II
Time Frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Maternal depression at baseline and post-treatment
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lynn F Katz, Ph.D., University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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