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

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ClinicalTrials.gov Identifier: NCT02409992
Recruitment Status : Recruiting
First Posted : April 7, 2015
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Lynn Fainsilber Katz, University of Washington

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).

Condition or disease Intervention/treatment Phase
Oppositional Defiant Disorder Behavioral: Parent Training plus Emotion Coaching Behavioral: Parent Training only Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions
Study Start Date : June 2015
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

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.
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409992


Contacts
Contact: Lynn F Katz, Ph.D. 206-616-4015 katzlf@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Lynn F Katz, PhD    206-616-4015    katzlf@uw.edu   
Principal Investigator: Lynn F Katz, PhD         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Lynn F Katz, Ph.D. University of Washington

Responsible Party: Lynn Fainsilber Katz, Research Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02409992     History of Changes
Other Study ID Numbers: STUDY00000931
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Lynn Fainsilber Katz, University of Washington:
Children with ODD and low prosocial emotions

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders