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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Deborah Jones, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01367847
First received: June 1, 2011
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  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 retention 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).


Condition Intervention Phase
Child Behavior
Parenting 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:

MedlinePlus related topics: Parenting
U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Sessions [ Time Frame: Baseline to Post-intervention (average 8 - 12 weeks) ] [ Designated as safety issue: No ]
    Number of sessions to complete the HNC or TE-HNC program

  • 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:
  • Parenting Behavior [ Time Frame: Baseline to Follow-Up (3 months Post-Intervention) ] [ Designated as safety issue: No ]
    Improvement in parenting behaviors

  • 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


Enrollment: 24
Study Start Date: September 2010
Estimated Study Completion Date: October 2012
Estimated 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 (iPhones, 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
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
National Institute of Mental Health (NIMH)
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: September 6, 2012
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 May 16, 2013