Technology-Enhanced Helping the Noncompliant Child (TE-HNC)

September 9, 2019 updated by: University of North Carolina, Chapel Hill

Technology Enhanced Delivery of Treatment for Early Conduct Problems

This study aimed to examine if technology could enhance the treatment engagement and outcomes of low income parents of 3 to 8 children with externalizing problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this pilot study is to determine whether a technology-enhanced version of an established behavioral treatment protocol, Helping the Noncompliant Child (HNC; McMahon & Forehand), enhances the engagement and treatment outcomes of lower income parents of 3 to 8 children with externalizing problems in treatment. It is predicted that families in both the HNC and technology-enhanced HNC (TE-HNC) programs will evidence significant improvement in parenting behavior and child externalizing problems; however, it is predicted that parent-child dyads in the TE-HNC program will require fewer sessions, will be more likely to be retained in the program, will be more likely to remain engaged in the program (e.g., practicing skills between sessions etc.), and will be more likely to have active involvement from their coparenting partners (i.e., other adults and family members who participate in childrearing).In turn, it is expected that the TE-HNC program will boost treatment outcomes.

Study Type

Interventional

Enrollment (Actual)

22

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, 27599
        • UNC Chapel Hill

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 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lower income
  • caregiver/parent is legal guardian
  • 3 to 8 year old child
  • child meets criteria for externalizing disorder or significant externalizing symptoms

Exclusion Criteria:

  • Prior report of child abuse or neglect
  • current substance abuse/dependence
  • legal guardian reading level less than 8th grade
  • child has developmental disability that precludes caregiver utilizing the skills

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Helping the Noncompliant Child (HNC)
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice & child behavior, reminders re: practice & sessions.
Behavioral: Helping the Noncompliant Child (HNC)
Well-established behavioral parent training program (McMahon & Forehand) for parents of 3 to 8 y.o. children with externalizing problems
Other Names:
  • HNC
Experimental: Technology-Enhanced HNC (TE-HNC)
Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice & child behavior, reminders re: practice & sessions.
Behavioral: Technology-Enhanced Helping the Noncompliant Child (TE-HNC)
Standard HNC program plus technology-enhancements (see description under Arm)
Other Names:
  • TE-HNC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: Baseline to Post-Intervention (average 8 to 12 weeks)
Retention assesses whether or not the family completed the full treatment program.
Baseline to Post-Intervention (average 8 to 12 weeks)
Mean % Sessions Attended as Scheduled
Time Frame: Baseline to Post-Intervention (average 8 to 12 weeks)
Participation in each weekly session as scheduled was recorded for each family. Mean attendance of scheduled sessions was computed for each parent-child dyad and then for each group. For example, if a parent-child dyad required 8 sessions to master the program skills and attended all 8 sessions as scheduled they would have 100%. If instead, another parent-child dyad also required 8 sessions to complete the program, but half of those were rescheduled at least once. Then the overall average attendance is calculated across the parent-child dyads in each group. Greater scheduled attendance = optimal outcome.
Baseline to Post-Intervention (average 8 to 12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Post-treatment Score Eyberg Child Behavior Inventory (ECBI)
Time Frame: Baseline to Post-Intervention (average 8 to 12 weeks)
The ECBI is a 36 item measure frequently used in treatment outcome research with young children, as it it reflects problem behavior in this age range and is sensitive to change. Parents rate the frequency of each problem behavior as occurring 0 = never to 7 = always. Scores can range from 0 to 252 with higher scores reflecting greater problem behaviors.
Baseline to Post-Intervention (average 8 to 12 weeks)
Mean Sessions for Complete Treatment
Time Frame: Baseline to Post-Intervention (Average 8 to 12 weeks)
Mean number of sessions that parent-child dyads in each group required to master the program skills and complete treatment (Fewer sessions to complete treatment considered more cost-effective as parent-child dyads learning skills more efficiently).
Baseline to Post-Intervention (Average 8 to 12 weeks)
Mean Consumer Satisfaction
Time Frame: Post-Intervention (Average 8 to 12 weeks)
Average parent-reported satisfaction with the treatment program on a project-developed consumer satisfaction scale (Possible range = 11 -77; Higher score = greater satisfaction).
Post-Intervention (Average 8 to 12 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, PhD, 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

September 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10-0740
  • 1R34MH082956-01A2 (U.S. NIH Grant/Contract)

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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