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

June 18, 2021 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed for the duration of treatment, an expected average of 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed through the duration of treatment and 6 additional months after treatment ends, an expected average of 9 months
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.
Treatment costs will be tracked through the duration of treatment, an expected average of 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Deborah J Jones, Ph.D., UNC Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

August 1, 2019

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (ESTIMATE)

July 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0078
  • R01MH100377 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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