Oppositional Defiant DisorderHNC-ECNCT02409992
Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions
A study testing Parent Training plus Emotion Coaching and Parent Training only in people with Oppositional Defiant Disorder, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Oppositional Defiant Disorder
- What is being tested?
- Parent Training plus Emotion Coaching and Parent Training only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with oppositional defiant disorder and low prosocial emotions
Who cannot join
- Unable to speak/understand English
- Significant developmental delay or autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Oppositional Defiant Disorder
- Being tested
- Parent Training plus Emotion Coaching, Parent Training only
- Keywords
- Children with ODD and low prosocial emotions
- Medical subject headings
- Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Training plus Emotion CoachingBehavioural
This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting program.
Parent Training onlyBehavioural
This intervention will consist of a parent management training program called Helping the Noncompliant Child.
| Study group | Role | What they receive |
|---|---|---|
| Parent Training plus Emotion Coaching | Experimental | This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting intervention. Receives: Behavioral: Parent Training plus Emotion Coaching |
| Parent Training Only | Active comparator | This intervention will consist of a parent management training program called Helping the Noncompliant Child. Receives: Behavioral: Parent Training only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory - intensity score
Child conduct problems at baseline, mid-treatment and post-treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Secondary outcomes (12)
Inventory of Callous-Unemotional Traits - preschool version - total score
Callous-unemotional traits at baseline mid-treatment and post-treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oppositional Defiant DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn Fainsilber Katz, University of Washington
- Investigators
- Lynn F Katz, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409992
- Sponsor's protocol ID
- STUDY00000931
- Acronym
- HNC-EC
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2015
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions
- ClinicalTrials.gov ID
- NCT02409992
- Acronym / sponsor ID
- HNC-EC / STUDY00000931
- Conditions
- Oppositional Defiant Disorder
- Keywords
- Children with ODD and low prosocial emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Training plus Emotion Coaching | Experimental | Behavioral: Parent Training plus Emotion CoachingThis intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting intervention. |
| Parent Training Only | Active comparator | Behavioral: Parent Training onlyThis intervention will consist of a parent management training program called Helping the Noncompliant Child. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child with oppositional defiant disorder and low prosocial emotions
Key exclusion criteria (2 listed)
- Unable to speak/understand English
- Significant developmental delay or autism spectrum disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Training plus Emotion CoachingThis intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting program. | Behavioural | Parent Training plus Emotion Coaching |
| Parent Training onlyThis intervention will consist of a parent management training program called Helping the Noncompliant Child. | Behavioural | Parent Training Only |
Primary outcome
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
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
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
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
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
12 secondary outcomes
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
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
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
Griffith Empathy Measure - empathy score
Time frame: 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
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
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
Parenting scale - overactivity
Time frame: 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
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
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 Sense of Competence efficacy scale
Time frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn F Katz, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Training plus Emotion Coaching and Parent Training only in people with Oppositional Defiant Disorder, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyberg Child Behavior Inventory - intensity score (time frame: Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.