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Technology to Enhance Treatment for Early Conduct Problems in Low Income Families (TE-HNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02191956
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : June 21, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE July 16, 2014
Last Update Posted Date June 21, 2021
Study Start Date  ICMJE April 2013
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Official Title  ICMJE Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Disruptive Behavior Disorders
Intervention  ICMJE Behavioral: Behavioral Parent Training
Weekly clinic session, mid-week call, home practice
Other Name: Parent Management Training
Study Arms  ICMJE
  • Active Comparator: Behavioral Parent Training
    Standard of care intervention
    Intervention: Behavioral: Behavioral Parent Training
  • Experimental: Behavioral Parent Training - Enhanced
    Standard of Care Behavioral Parent Training plus new delivery methods
    Intervention: Behavioral: Behavioral Parent Training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
101
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2014)
102
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02191956
Other Study ID Numbers  ICMJE 13-0078
R01MH100377 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of North Carolina, Chapel Hill
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Deborah J Jones, Ph.D. UNC Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP