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History of Changes for Study: NCT02191956
Technology to Enhance Treatment for Early Conduct Problems in Low Income Families (TE-HNC)
Latest version (submitted June 18, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 14, 2014 None (earliest Version on record)
2 February 12, 2015 Study Status
3 November 2, 2015 Study Status
4 May 12, 2016 Study Status
5 October 2, 2017 Study Status
6 October 15, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 September 9, 2019 Recruitment Status and Study Status
8 June 18, 2021 Study Status and Contacts/Locations
Comparison Format:

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Study NCT02191956
Submitted Date:  July 14, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 13-0078
Brief Title: Technology to Enhance Treatment for Early Conduct Problems in Low Income Families (TE-HNC)
Official Title: Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Secondary IDs: R01MH100377 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Recruiting
Study Start: April 2013
Primary Completion: July 2017 [Anticipated]
Study Completion: July 2017 [Anticipated]
First Submitted: June 18, 2014
First Submitted that
Met QC Criteria:
July 14, 2014
First Posted: July 16, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 14, 2014
Last Update Posted: July 16, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of North Carolina, Chapel Hill
Responsible Party: Sponsor
Collaborators: National Institute of Mental Health (NIMH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description: 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.
Open or close this module Conditions
Conditions: Disruptive Behavior Disorders
Keywords: Disruptive behavior disorders
Early Onset
Young Children
Parenting
Behavioral Parent Training
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 102 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Behavioral Parent Training
Standard of care intervention
Behavioral: Behavioral Parent Training
Weekly clinic session, mid-week call, home practice
Other Names:
  • Parent Management Training
Experimental: Behavioral Parent Training - Enhanced
Standard of Care Behavioral Parent Training plus new delivery methods
Behavioral: Behavioral Parent Training
Weekly clinic session, mid-week call, home practice
Other Names:
  • Parent Management Training
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Engagement
[ Time Frame: Participants will be followed for the duration of treatment, an expected average of 10 weeks ]

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.
Secondary Outcome Measures:
1. Change in Disruptive Behavior from the start of treatment through 6 months after treatment ends
[ Time Frame: Participants will be followed through the duration of treatment and 6 additional months after treatment ends, an expected average of 9 months ]

Disruptive behavior includes multiple dimensions of behavior, including items assessing noncompliance, aggression, and oppositionality.
2. Treatment Cost
[ Time Frame: Treatment costs will be tracked through the duration of treatment, an expected average of 10 weeks ]

Cost is a multidimensional measure that includes items assessing both start-up (e.g., technology development) and implementation (e.g., therapist time) costs.
Open or close this module Eligibility
Minimum Age: 3 Years
Maximum Age: 7 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Child aged 3 to 7 years
  • has clinically significant disruptive behaviors
  • low-income family

Exclusion Criteria:

  • Caregiver has current mood, substance use, and/or psychotic disorder
  • Child has current pervasive developmental and/or psychotic disorder
  • Family has current allegation and/or past substantiation with child protective services
Open or close this module Contacts/Locations
Central Contact Person: Patrick Turner, B.A.
Telephone: 919-843-2351
Email: tantrumtamers@unc.edu
Central Contact Backup: Deborah J Jones, Ph.D.
Telephone: 919-962-3995
Email: djjones@email.unc.edu
Study Officials: Deborah J Jones, Ph.D.
Principal Investigator
UNC Chapel Hill
Locations: United States, North Carolina
UNC Department of Psychology Community Research Center and Clinic
[Recruiting]
Chapel Hill, North Carolina, United States, 27514
Contact:Contact: Patrick Turner, B.A. 919-843-2351 tantrumtamers@unc.edu
Contact:Principal Investigator: Deborah J Jones, Ph.D.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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