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OpenTrials
Completed

NCT Number: NCT02191956

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

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.

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Key information

Conditions

Disruptive Behavior Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Department of Psychology

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Parent Training

Behavioral

Weekly clinic session, mid-week call, home practice

Other names: Parent Management Training

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: TE-HNC

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2014
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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