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On-line Treatment for Conduct Problems

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ClinicalTrials.gov Identifier: NCT01822392
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : February 6, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alan E. Kazdin, Yale University

Brief Summary:
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 or disease Intervention/treatment Phase
Conduct Disorder Oppositional Defiant Disorder Behavioral: Online Parent Management Training (Interactive) Behavioral: Online Parent Management Training (Recorded) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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) ]
    Internalizing and externalizing behavior problems in children

  2. 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) ]
    Therapist-rated measure of overall child impairment and functioning

  3. 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) ]
    Presence of a broad range of overt and covert antisocial behaviors in children

  4. 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) ]
    Clinical symptoms and diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria


Secondary Outcome Measures :
  1. 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) ]
    Sources of stress for the parent

  2. 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) ]
    Parental symptoms of depression

  3. 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) ]
    Parenting practices

  4. Parent-Therapist Relationship Scale (Therapist version) [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Characteristics of the therapeutic relationship according to therapist report

  5. Parent-Therapist Relationship Scale (Therapist version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Characteristics of the therapeutic relationship according to therapist report

  6. Parent-Therapist Relationship Scale (Parent version) [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Characteristics of the therapeutic relationship according to parent report

  7. Parent-Therapist Relationship Scale (Parent version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Characteristics of the therapeutic relationship according to parent report

  8. Barriers to Participation in Treatment (Therapist version) [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Stressors and obstacles that interfere with treatment

  9. Barriers to Participation in Treatment (Therapist version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Stressors and obstacles that interfere with treatment

  10. Barriers to Participation in Treatment (Parent version) [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Stressors and obstacles that interfere with treatment

  11. Barriers to Participation in Treatment (Parent version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Stressors and obstacles that interfere with treatment

  12. Weekly Participation in Treatment [ Time Frame: Weekly (during treatment) ]
    Attendance and participation in treatment sessions

  13. Treatment Adherence Inventory (Therapist version) [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Parental compliance with specific treatment techniques

  14. Treatment Adherence Inventory (Therapist version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Parental compliance with specific treatment techniques

  15. Treatment Adherence Inventory (Parent version) [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Parental compliance with specific treatment techniques

  16. Treatment Adherence Inventory (Parent version) [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Parental compliance with specific treatment techniques

  17. Therapist Evaluation Inventory [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Acceptability of treatment based on therapist report

  18. Therapist Evaluation Inventory [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Acceptability of treatment based on therapist report

  19. Parent Evaluation Inventory [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Acceptability of treatment based on parent report

  20. Parent Evaluation Inventory [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Acceptability of treatment based on parent report

  21. Acceptability of Treatment Modality [ Time Frame: Midtreatment (Week 4 of treatment) ]
    Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically

  22. Acceptability of Treatment Modality [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically


Other Outcome Measures:
  1. Perspectives on Treatment Interview [ Time Frame: Posttreatment (immediately after treatment is completed; Week 8) ]
    Open-ended interview questions about parents' experiences in treatment and their impressions of different aspects of online treatment delivery



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

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): NCT01822392


Locations
United States, Connecticut
Yale Parenting Center
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Alan E. Kazdin, Ph.D. Yale University

Responsible Party: Alan E. Kazdin, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01822392     History of Changes
Other Study ID Numbers: 1108008914
1R34MH093326-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015

Keywords provided by Alan E. Kazdin, Yale University:
Online treatment
Treatment of conduct problems
Parent training

Additional relevant MeSH terms:
Disease
Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders