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

Primary Purpose

Oppositional Defiant Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Training plus Emotion Coaching
Parent Training only
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional Defiant Disorder focused on measuring Children with ODD and low prosocial emotions

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parent Training plus Emotion Coaching

Parent Training Only

Arm Description

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 consist of a parent management training program called Helping the Noncompliant Child.

Outcomes

Primary Outcome Measures

Eyberg Child Behavior Inventory - intensity score
Child conduct problems at baseline, mid-treatment and post-treatment
Early Childhood Inventory-4 ODD scale
Change in child conduct problems for children ages 3-5 at baseline, mid-treatment and post-treatment
Child Symptom Inventory-IV
Child conduct problems for children ages 6-7 at baseline, mid-treatment and post-treatment
Behavioral Coding System - percent child inappropriate behaviors
Child inappropriate behaviors at baseline, mid-treatment and post-treatment
Behavioral Coding System percent child compliance
Child compliance at baseline, mid-treatment and post-treatment

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2015
Last Updated
April 29, 2021
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT02409992
Brief Title
Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions
Acronym
HNC-EC
Official Title
Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
December 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder
Keywords
Children with ODD and low prosocial emotions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Training plus Emotion Coaching
Arm Type
Experimental
Arm Description
This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting intervention.
Arm Title
Parent Training Only
Arm Type
Active Comparator
Arm Description
This intervention will consist of a parent management training program called Helping the Noncompliant Child.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training plus Emotion Coaching
Intervention Description
This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting program.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training only
Intervention Description
This intervention will consist of a parent management training program called Helping the Noncompliant Child.
Primary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory - intensity score
Description
Child conduct problems at baseline, mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Early Childhood Inventory-4 ODD scale
Description
Change in child conduct problems for children ages 3-5 at baseline, mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Child Symptom Inventory-IV
Description
Child conduct problems for children ages 6-7 at baseline, mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Behavioral Coding System - percent child inappropriate behaviors
Description
Child inappropriate behaviors at baseline, mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Behavioral Coding System percent child compliance
Description
Child compliance at baseline, mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Secondary Outcome Measure Information:
Title
Inventory of Callous-Unemotional Traits - preschool version - total score
Description
Callous-unemotional traits at baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
A Developmental Neuropsychological Assessment (NEPSY-II) Affect Recognition Task - fear recognition
Description
Affect recognition at baseline, mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
NEPSY-II Affect Recognition Task - sadness recognition
Description
Affect recognition in baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Griffith Empathy Measure - empathy score
Description
Empathy at baseline and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Behavioral coding of Zahn-Waxler empathy paradigm - amount of attention, affective response congruent with examiner, concern for others, disregard for others
Description
Empathy at baseline and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Behavioral Coding System - positive attention rate per minute
Description
Parenting behavior - positive attention at baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Behavioral Coding System - total commands rate per minute
Description
Change in parenting behavior - commands at baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Parenting scale - overactivity
Description
Parenting at baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Parenting scale - laxness
Description
Parenting at baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Parent Meta-Emotion Interview emotion coaching scale
Description
Emotion coaching at baseline and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Parenting Sense of Competence satisfaction scale
Description
Parenting satisfaction at baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Parenting Sense of Competence efficacy scale
Description
Parenting efficacy at baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Other Pre-specified Outcome Measures:
Title
Difficulties with Emotion Regulation Scale - lack of awareness and limited access to emotion regulation strategies
Description
Maternal emotion regulation abilities at baseline mid-treatment and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Title
Beck Depression Inventory II
Description
Maternal depression at baseline and post-treatment
Time Frame
Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn F Katz, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions

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