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

Primary Purpose

Disruptive Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Parent Training
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disruptive Behavior Disorders focused on measuring Disruptive behavior disorders, Early Onset, Young Children, Parenting, Behavioral Parent Training

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Behavioral Parent Training

Behavioral Parent Training - Enhanced

Arm Description

Standard of care intervention

Standard of Care Behavioral Parent Training plus new delivery methods

Outcomes

Primary Outcome Measures

Engagement
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

Change in Disruptive Behavior from the start of treatment through 6 months after treatment ends
Disruptive behavior includes multiple dimensions of behavior, including items assessing noncompliance, aggression, and oppositionality.
Treatment Cost
Cost is a multidimensional measure that includes items assessing both start-up (e.g., technology development) and implementation (e.g., therapist time) costs.

Full Information

First Posted
June 18, 2014
Last Updated
June 18, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02191956
Brief Title
Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Acronym
TE-HNC
Official Title
Technology to Enhance Treatment for Early Conduct Problems in Low Income Families
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior Disorders
Keywords
Disruptive behavior disorders, Early Onset, Young Children, Parenting, Behavioral Parent Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Parent Training
Arm Type
Active Comparator
Arm Description
Standard of care intervention
Arm Title
Behavioral Parent Training - Enhanced
Arm Type
Experimental
Arm Description
Standard of Care Behavioral Parent Training plus new delivery methods
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Parent Training
Other Intervention Name(s)
Parent Management Training
Intervention Description
Weekly clinic session, mid-week call, home practice
Primary Outcome Measure Information:
Title
Engagement
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.
Time Frame
Participants will be followed for the duration of treatment, an expected average of 10 weeks
Secondary Outcome Measure Information:
Title
Change in Disruptive Behavior from the start of treatment through 6 months after treatment ends
Description
Disruptive behavior includes multiple dimensions of behavior, including items assessing noncompliance, aggression, and oppositionality.
Time Frame
Participants will be followed through the duration of treatment and 6 additional months after treatment ends, an expected average of 9 months
Title
Treatment Cost
Description
Cost is a multidimensional measure that includes items assessing both start-up (e.g., technology development) and implementation (e.g., therapist time) costs.
Time Frame
Treatment costs will be tracked through the duration of treatment, an expected average of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah J Jones, Ph.D.
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Department of Psychology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34888861
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.
Results Reference
derived
PubMed Identifier
28581304
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.
Results Reference
derived
PubMed Identifier
26053349
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.
Results Reference
derived

Learn more about this trial

Technology to Enhance Treatment for Early Conduct Problems in Low Income Families

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