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

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ClinicalTrials.gov Identifier: NCT01367847
Recruitment Status : Completed
First Posted : June 7, 2011
Results First Posted : September 14, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Child Externalizing Behavior Behavioral: Helping the Noncompliant Child (HNC) Behavioral: Technology-Enhanced Helping the Noncompliant Child (TE-HNC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Technology Enhanced Delivery of Treatment for Early Conduct Problems
Study Start Date : September 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : May 2013

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 Name: 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 Name: TE-HNC




Primary Outcome Measures :
  1. Retention [ Time Frame: Baseline to Post-Intervention (average 8 to 12 weeks) ]
    Retention assesses whether or not the family completed the full treatment program.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).



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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367847


Locations
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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
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Principal Investigator: Deborah J Jones, PhD UNC Chapel Hill
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01367847    
Other Study ID Numbers: 10-0740
1R34MH082956-01A2 ( U.S. NIH Grant/Contract )
First Posted: June 7, 2011    Key Record Dates
Results First Posted: September 14, 2018
Last Update Posted: September 11, 2019
Last Verified: September 2019
Keywords provided by University of North Carolina, Chapel Hill:
Parenting
Parent-Child Relations
Child Behavior