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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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 program.
Active Comparator: Parent Training Only
This intervention will consist of a parent management training program called Helping the Noncompliant Child.
Behavioral: Parent Training only
This intervention will consist of a parent management training program called Helping the Noncompliant Child.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000931

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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