Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-21 @ 10:12 PM
Study NCT ID:
NCT02191956
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2014-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engagement', 'timeFrame': 'Participants will be followed for the duration of treatment, an expected average of 10 weeks', 'description': 'Engagement includes multiple dimensions of participation in the treatment process, including items assessing attendance at weekly sessions, participation in mid-week calls, and home practice of skills.'}], 'secondaryOutcomes': [{'measure': 'Change in Disruptive Behavior from the start of treatment through 6 months after treatment ends', 'timeFrame': 'Participants will be followed through the duration of treatment and 6 additional months after treatment ends, an expected average of 9 months', 'description': 'Disruptive behavior includes multiple dimensions of behavior, including items assessing noncompliance, aggression, and oppositionality.'}, {'measure': 'Treatment Cost', 'timeFrame': 'Treatment costs will be tracked through the duration of treatment, an expected average of 10 weeks', 'description': 'Cost is a multidimensional measure that includes items assessing both start-up (e.g., technology development) and implementation (e.g., therapist time) costs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Disruptive behavior disorders', 'Early Onset', 'Young Children', 'Parenting', 'Behavioral Parent Training'], 'conditions': ['Disruptive Behavior Disorders']}, 'referencesModule': {'references': [{'pmid': '40010899', 'type': 'DERIVED', 'citation': 'Yang Y, Parent J, Gil KM, Jones DJ. The Efficacy of Technology-Enhanced Behavioral Parent Training for Families With Low Income: Do Parent-Centered Profiles Moderate Treatment Outcomes? Behav Ther. 2025 Mar;56(2):261-275. doi: 10.1016/j.beth.2024.10.002. Epub 2024 Oct 18.'}, {'pmid': '39514027', 'type': 'DERIVED', 'citation': 'Highlander A, Parent J, J Jones D. Helping the Noncompliant Child and Child Behavior Outcomes: An Exploratory Examination of Financial Strain. Prev Sci. 2025 May;26(4):542-554. doi: 10.1007/s11121-024-01749-9. Epub 2024 Nov 8.'}, {'pmid': '34888861', 'type': 'DERIVED', 'citation': 'Parent J, Anton MT, Loiselle R, Highlander A, Breslend N, Forehand R, Hare M, Youngstrom JK, Jones DJ. A randomized controlled trial of technology-enhanced behavioral parent training: sustained parent skill use and child outcomes at follow-up. J Child Psychol Psychiatry. 2022 Sep;63(9):992-1001. doi: 10.1111/jcpp.13554. Epub 2021 Dec 9.'}, {'pmid': '28581304', 'type': 'DERIVED', 'citation': 'Faro AL, McKee LG, Garcia RL, Jones DJ. The relationships between religiosity and youth internalizing symptoms in African American parent-adolescent dyads. Cultur Divers Ethnic Minor Psychol. 2018 Jan;24(1):139-149. doi: 10.1037/cdp0000158. Epub 2017 Jun 5.'}, {'pmid': '26053349', 'type': 'DERIVED', 'citation': 'Anton MT, Jones DJ, Youngstrom EA. Socioeconomic status, parenting, and externalizing problems in African American single-mother homes: A person-oriented approach. J Fam Psychol. 2015 Jun;29(3):405-415. doi: 10.1037/fam0000086.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to the test the efficacy and cost effectiveness of new service delivery methods to enhance the reach and impact of the standard of care treatment, Behavioral Parent Training (BPT), for early onset disruptive behavior disorders.', 'detailedDescription': 'Families will be randomized to one of two active treatment conditions, the standard BPT program or the standard BPT program plus some new service delivery methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child aged 3 to 7 years\n* has clinically significant disruptive behaviors\n* low-income family\n\nExclusion Criteria:\n\n* Caregiver has current mood, substance use, and/or psychotic disorder\n* Child has current pervasive developmental and/or psychotic disorder\n* Family has current allegation and/or past substantiation with child protective services'}, 'identificationModule': {'nctId': 'NCT02191956', 'acronym': 'TE-HNC', 'briefTitle': 'Technology to Enhance Treatment for Early Conduct Problems in Low Income Families', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Technology to Enhance Treatment for Early Conduct Problems in Low Income Families', 'orgStudyIdInfo': {'id': '13-0078'}, 'secondaryIdInfos': [{'id': 'R01MH100377', 'link': 'https://reporter.nih.gov/quickSearch/R01MH100377', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral Parent Training', 'description': 'Standard of care intervention', 'interventionNames': ['Behavioral: Behavioral Parent Training']}, {'type': 'EXPERIMENTAL', 'label': 'Behavioral Parent Training - Enhanced', 'description': 'Standard of Care Behavioral Parent Training plus new delivery methods', 'interventionNames': ['Behavioral: Behavioral Parent Training']}], 'interventions': [{'name': 'Behavioral Parent Training', 'type': 'BEHAVIORAL', 'otherNames': ['Parent Management Training'], 'description': 'Weekly clinic session, mid-week call, home practice', 'armGroupLabels': ['Behavioral Parent Training', 'Behavioral Parent Training - Enhanced']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Department of Psychology', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Deborah J Jones, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}