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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Jones, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01367847
First received: June 1, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Child Externalizing Behavior
Behavioral: Helping the Noncompliant Child (HNC)
Behavioral: Technology-Enhanced Helping the Noncompliant Child (TE-HNC)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Technology Enhanced Delivery of Treatment for Early Conduct Problems

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Retention [ Time Frame: Baseline to Post-Intervention (average 8 to 12 weeks) ] [ Designated as safety issue: No ]
    Completion of the HNC or TE-HNC program

  • Engagement [ Time Frame: Baseline to Post-Intervention (average 8 to 12 weeks) ] [ Designated as safety issue: No ]
    Participation in in-and out-of-session HNC and TE-HNC program skills, including out-of-session practice, etc.


Secondary Outcome Measures:
  • Child Externalizing Disorders [ Time Frame: Baseline to Follow-Up (3 months Post-Intervention) ] [ Designated as safety issue: No ]
    Child no longer meeting criteria for an externalizing diagnosis or reduction in externalizing symptoms

  • Cost-Effectiveness [ Time Frame: Baseline to Follow-Up (3 months Post-Intervention) ] [ Designated as safety issue: No ]
    Cost of HNC and TE-HNC program, value added by technology-enhancements

  • Consumer Satisfaction [ Time Frame: Post- and Follow-Up Assessment ] [ Designated as safety issue: No ]
    Satisfaction with HNC Program, as well as technology-enhancements (TE-HNC only)


Enrollment: 22
Study Start Date: September 2010
Study Completion Date: May 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HNC
Helping the Noncompliant Child (McMahon & Forehand), a well-established behavioral parent training program for parents of 3 to 8 year old children with externalizing problems
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 Name: HNC
Experimental: TE-HNC
Standard HNC 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 Name: TE-HNC

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367847

Locations
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Deborah J Jones, PhD UNC Chapel Hill
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah Jones, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01367847     History of Changes
Other Study ID Numbers: 10-0740, 1R34MH082956-01A2
Study First Received: June 1, 2011
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Parenting
Parent-Child Relations
Child Behavior

ClinicalTrials.gov processed this record on September 18, 2014