- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02409992
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
Completed
Conditions
Intervention / Treatment
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
-
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID 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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