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

Disruptive Behavior Disorders Clinical Trial

— TE-HNC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191956
• Other study ID #: 13-0078
• Secondary ID: R01MH100377
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: August 2019

Study information

• Verified date: June 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Disruptive Behavior Disorders
• Mental Disorders
• Problem Behavior

Intervention

Behavioral:
• Behavioral Parent Training
Weekly clinic session, mid-week call, home practice

Locations

Country	Name	City	State
United States	UNC Department of Psychology	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of treatment, an expected average of 10 weeks
Secondary	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.	Participants will be followed through the duration of treatment and 6 additional months after treatment ends, an expected average of 9 months
Secondary	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.	Treatment costs will be tracked through the duration of treatment, an expected average of 10 weeks