Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT02409992
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096865', 'term': 'Oppositional Defiant Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difficulties with Emotion Regulation Scale - lack of awareness and limited access to emotion regulation strategies', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Maternal emotion regulation abilities at baseline mid-treatment and post-treatment'}, {'measure': 'Beck Depression Inventory II', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Maternal depression at baseline and post-treatment'}], 'primaryOutcomes': [{'measure': 'Eyberg Child Behavior Inventory - intensity score', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Child conduct problems at baseline, mid-treatment and post-treatment'}, {'measure': 'Early Childhood Inventory-4 ODD scale', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Change in child conduct problems for children ages 3-5 at baseline, mid-treatment and post-treatment'}, {'measure': 'Child Symptom Inventory-IV', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Child conduct problems for children ages 6-7 at baseline, mid-treatment and post-treatment'}, {'measure': 'Behavioral Coding System - percent child inappropriate behaviors', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Child inappropriate behaviors at baseline, mid-treatment and post-treatment'}, {'measure': 'Behavioral Coding System percent child compliance', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Child compliance at baseline, mid-treatment and post-treatment'}], 'secondaryOutcomes': [{'measure': 'Inventory of Callous-Unemotional Traits - preschool version - total score', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Callous-unemotional traits at baseline mid-treatment and post-treatment'}, {'measure': 'A Developmental Neuropsychological Assessment (NEPSY-II) Affect Recognition Task - fear recognition', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Affect recognition at baseline, mid-treatment and post-treatment'}, {'measure': 'NEPSY-II Affect Recognition Task - sadness recognition', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Affect recognition in baseline mid-treatment and post-treatment'}, {'measure': 'Griffith Empathy Measure - empathy score', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Empathy at baseline and post-treatment'}, {'measure': 'Behavioral coding of Zahn-Waxler empathy paradigm - amount of attention, affective response congruent with examiner, concern for others, disregard for others', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Empathy at baseline and post-treatment'}, {'measure': 'Behavioral Coding System - positive attention rate per minute', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Parenting behavior - positive attention at baseline mid-treatment and post-treatment'}, {'measure': 'Behavioral Coding System - total commands rate per minute', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Change in parenting behavior - commands at baseline mid-treatment and post-treatment'}, {'measure': 'Parenting scale - overactivity', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Parenting at baseline mid-treatment and post-treatment'}, {'measure': 'Parenting scale - laxness', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Parenting at baseline mid-treatment and post-treatment'}, {'measure': 'Parent Meta-Emotion Interview emotion coaching scale', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Emotion coaching at baseline and post-treatment'}, {'measure': 'Parenting Sense of Competence satisfaction scale', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Parenting satisfaction at baseline mid-treatment and post-treatment'}, {'measure': 'Parenting Sense of Competence efficacy scale', 'timeFrame': 'Participants will be followed for the duration of outpatient treatment, an expected average of 25 weeks', 'description': 'Parenting efficacy at baseline mid-treatment and post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Children with ODD and low prosocial emotions'], 'conditions': ['Oppositional Defiant Disorder']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child with oppositional defiant disorder and low prosocial emotions\n\nExclusion Criteria:\n\n* Unable to speak/understand English\n* Significant developmental delay or autism spectrum disorder'}, 'identificationModule': {'nctId': 'NCT02409992', 'acronym': 'HNC-EC', 'briefTitle': 'Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions', 'orgStudyIdInfo': {'id': 'STUDY00000931'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parent Training plus Emotion Coaching', 'description': 'This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting intervention.', 'interventionNames': ['Behavioral: Parent Training plus Emotion Coaching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Parent Training Only', 'description': 'This intervention will consist of a parent management training program called Helping the Noncompliant Child.', 'interventionNames': ['Behavioral: Parent Training only']}], 'interventions': [{'name': 'Parent Training plus Emotion Coaching', 'type': 'BEHAVIORAL', 'description': 'This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting program.', 'armGroupLabels': ['Parent Training plus Emotion Coaching']}, {'name': 'Parent Training only', 'type': 'BEHAVIORAL', 'description': 'This intervention will consist of a parent management training program called Helping the Noncompliant Child.', 'armGroupLabels': ['Parent Training Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lynn F Katz, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Lynn Fainsilber Katz', 'investigatorAffiliation': 'University of Washington'}}}}