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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT02191956

Collaborator

National Institute of Mental Health (NIMH) (NIH)

101

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Disruptive Behavior Disorders	Behavioral: Behavioral Parent Training	N/A

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

Study Type:

Interventional

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 :

Apr 1, 2013

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Engagement [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

Change in Disruptive Behavior from the start of treatment through 6 months after treatment ends [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 [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

Criteria

Ages Eligible for Study:

3 Years to 7 Years

Sexes Eligible for Study:

All

Accepts 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