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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Disruptive Behavior Disorders Behavioral: Behavioral Parent Training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Study Start Date : April 2013
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Behavioral Parent Training
Standard of care intervention
 Behavioral: Behavioral Parent Training
Weekly clinic session, mid-week call, home practice
Other Name: 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 Name: Parent Management Training


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191956


Locations
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United States, North Carolina
UNC Department of Psychology
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Deborah J Jones, Ph.D. UNC Chapel Hill
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02191956    
Other Study ID Numbers: 13-0078
R01MH100377 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Keywords provided by University of North Carolina, Chapel Hill:
Disruptive behavior disorders
Early Onset
Young Children
Parenting
Behavioral Parent Training
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Behavioral Symptoms
Neurodevelopmental Disorders