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

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT02409992
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Duration (Months): 42.5
• Patients Per Site Per Month: 1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Oppositional Defiant Disorder	Behavioral: Parent Training plus Emotion Coaching; Behavioral: Parent Training only	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 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: Jun 1, 2015
• Actual Primary Completion Date: Dec 15, 2018
• Actual Study Completion Date: Dec 15, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Eyberg Child Behavior Inventory - intensity score [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks]

   Maternal depression at baseline and post-treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

• University of Washington

Investigators

• Principal Investigator: Lynn F Katz, Ph.D., University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lynn Fainsilber Katz, Research Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT02409992
• Other Study ID Numbers: STUDY00000931
• First Posted: Apr 7, 2015
• Last Update Posted: May 5, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by Lynn Fainsilber Katz, Research Professor, University of Washington: Children with ODD and low prosocial emotions
• Additional relevant MeSH terms: Attention Deficit and Disruptive Behavior Disorders

Study Results

No Results Posted as of May 5, 2021