Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions

Study Overview
=================
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).

Official Title
-----------------
Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions

Conditions
-----------------
Oppositional Defiant Disorder

Intervention / Treatment
-----------------
* Behavioral: Parent Training plus Emotion Coaching
* Behavioral: Parent Training only


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Training plus Emotion Coaching<br>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<br>* This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting program.<br>|
| Active Comparator: Parent Training Only<br>This intervention will consist of a parent management training program called Helping the Noncompliant Child. | Behavioral: Parent Training only<br>* This intervention will consist of a parent management training program called Helping the Noncompliant Child.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children with ODD and low prosocial emotions