On-line Treatment for Conduct Problems

This study is currently recruiting participants.
Verified March 2013 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alan E. Kazdin, Yale University
ClinicalTrials.gov Identifier:
NCT01822392
First received: March 22, 2013
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

The research evaluates the use of online versions of delivering an effective psychological treatment for children clinically referred for serious oppositional, aggressive, and antisocial behavior. The goal is to develop models of delivery that reach families in need that are not being served by in-person treatment. The project has immediate implications for the treatment of children but more generally addresses several issues critical to treatments that are based on Internet, telepsychiatry, and related technologies.


Condition Intervention
Conduct Disorder
Oppositional Defiant Disorder
Behavioral: Online Parent Management Training (Interactive)
Behavioral: Online Parent Management Training (Recorded)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Child Behavior Checklist [ Time Frame: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Internalizing and externalizing behavior problems in children

  • Child Global Assessment Scale [ Time Frame: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Therapist-rated measure of overall child impairment and functioning

  • Interview for Antisocial Behavior [ Time Frame: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Presence of a broad range of overt and covert antisocial behaviors in children

  • Research Diagnostic Interview [ Time Frame: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Clinical symptoms and diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria


Secondary Outcome Measures:
  • Parenting Stress Index [ Time Frame: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Sources of stress for the parent

  • Beck Depression Inventory [ Time Frame: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Parental symptoms of depression

  • Management of Child Behavior Scale [ Time Frame: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Parenting practices

  • Parent-Therapist Relationship Scale (Therapist version) [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Characteristics of the therapeutic relationship according to therapist report

  • Parent-Therapist Relationship Scale (Therapist version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Characteristics of the therapeutic relationship according to therapist report

  • Parent-Therapist Relationship Scale (Parent version) [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Characteristics of the therapeutic relationship according to parent report

  • Parent-Therapist Relationship Scale (Parent version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Characteristics of the therapeutic relationship according to parent report

  • Barriers to Participation in Treatment (Therapist version) [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Stressors and obstacles that interfere with treatment

  • Barriers to Participation in Treatment (Therapist version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Stressors and obstacles that interfere with treatment

  • Barriers to Participation in Treatment (Parent version) [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Stressors and obstacles that interfere with treatment

  • Barriers to Participation in Treatment (Parent version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Stressors and obstacles that interfere with treatment

  • Weekly Participation in Treatment [ Time Frame: Weekly (during treatment) ] [ Designated as safety issue: No ]
    Attendance and participation in treatment sessions

  • Treatment Adherence Inventory (Therapist version) [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Parental compliance with specific treatment techniques

  • Treatment Adherence Inventory (Therapist version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Parental compliance with specific treatment techniques

  • Treatment Adherence Inventory (Parent version) [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Parental compliance with specific treatment techniques

  • Treatment Adherence Inventory (Parent version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Parental compliance with specific treatment techniques

  • Therapist Evaluation Inventory [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Acceptability of treatment based on therapist report

  • Therapist Evaluation Inventory [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Acceptability of treatment based on therapist report

  • Parent Evaluation Inventory [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Acceptability of treatment based on parent report

  • Parent Evaluation Inventory [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Acceptability of treatment based on parent report

  • Acceptability of Treatment Modality [ Time Frame: Midtreatment (Week 4 of treatment) ] [ Designated as safety issue: No ]
    Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically

  • Acceptability of Treatment Modality [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically


Other Outcome Measures:
  • Perspectives on Treatment Interview [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ] [ Designated as safety issue: No ]
    Open-ended interview questions about parents' experiences in treatment and their impressions of different aspects of online treatment delivery


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Online treatment, High therapist contact
Participants receive online Parent Management Training (interactive).
Behavioral: Online Parent Management Training (Interactive)
Experimental: Online treatment, Low therapist contact
Participants receive online Parent Management Training (recorded).
Behavioral: Online Parent Management Training (Recorded)

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Conduct Disorder of Oppositional Defiant Disorder (for the child)
  • Residence in the state of CT
  • Access to a computer and high-speed Internet access
  • English fluency (at least one parent)
  • No history of significant developmental delay (for the child)
  • Parental consent

Exclusion Criteria:

  • Participation in another form of psychotherapy or counseling that is directed toward the reduction of social, emotional, or behavioral problems
  • Evidence of recent suicidality (for the child)
  • Current or lifetime diagnosis of a Pervasive Developmental Disorder
  • Primary diagnoses of a mood or anxiety disorder
  • Acute family crisis
  • Parent or guardian who can participate in treatment shows current psychosis or an uncontrolled medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822392

Contacts
Contact: Sarah M. Rabbitt, Ph.D. 203-436-9325 sarah.rabbitt@yale.edu

Locations
United States, Connecticut
Yale Parenting Center Recruiting
New Haven, Connecticut, United States, 06511
Contact: Jennifer Pope, B.A.    203-432-9764    jennifer.pope@yale.edu   
Principal Investigator: Alan E. Kazdin, Ph.D.         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Alan E. Kazdin, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Alan E. Kazdin, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01822392     History of Changes
Other Study ID Numbers: 1108008914, 1R34MH093326-01A1
Study First Received: March 22, 2013
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Yale University:
Online treatment
Treatment of conduct problems
Parent training

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014