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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02409992
Other study ID # STUDY00000931
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date December 15, 2018

Study information

Verified date April 2021
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 15, 2018
Est. primary completion date December 15, 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.
Parent Training only
This intervention will consist of a parent management training program called Helping the Noncompliant Child.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Difficulties with Emotion Regulation Scale - lack of awareness and limited access to emotion regulation strategies 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
Other Beck Depression Inventory II Maternal depression at baseline and post-treatment Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Primary Eyberg Child Behavior Inventory - intensity score 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
Primary Early Childhood Inventory-4 ODD scale 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
Primary Child Symptom Inventory-IV 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
Primary Behavioral Coding System - percent child inappropriate behaviors 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
Primary Behavioral Coding System percent child compliance 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 Inventory of Callous-Unemotional Traits - preschool version - total score 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
Secondary A Developmental Neuropsychological Assessment (NEPSY-II) Affect Recognition Task - fear recognition 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
Secondary NEPSY-II Affect Recognition Task - sadness recognition 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
Secondary Griffith Empathy Measure - empathy score Empathy at baseline and post-treatment Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Secondary 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 Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Secondary Behavioral Coding System - positive attention rate per minute 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
Secondary Behavioral Coding System - total commands rate per minute 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
Secondary Parenting scale - overactivity Parenting at baseline mid-treatment and post-treatment Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Secondary Parenting scale - laxness Parenting at baseline mid-treatment and post-treatment Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Secondary Parent Meta-Emotion Interview emotion coaching scale Emotion coaching at baseline and post-treatment Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Secondary Parenting Sense of Competence satisfaction scale 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
Secondary Parenting Sense of Competence efficacy scale 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
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