Back to resultsOn-line Treatment for Conduct Problems
Primary Purpose
Conduct Disorder, Oppositional Defiant Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Parent Management Training (Interactive)
Online Parent Management Training (Recorded)
Sponsored by
About this trial
This is an interventional treatment trial for Conduct Disorder focused on measuring Online treatment, Treatment of conduct problems, Parent training
Eligibility 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
Sites / Locations
- Yale Parenting Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Online treatment, High therapist contact
Online treatment, Low therapist contact
Arm Description
Participants receive online Parent Management Training (interactive).
Participants receive online Parent Management Training (recorded).
Outcomes
Primary Outcome Measures
Child Behavior Checklist
Internalizing and externalizing behavior problems in children
Child Global Assessment Scale
Therapist-rated measure of overall child impairment and functioning
Interview for Antisocial Behavior
Presence of a broad range of overt and covert antisocial behaviors in children
Research Diagnostic Interview
Clinical symptoms and diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
Secondary Outcome Measures
Parenting Stress Index
Sources of stress for the parent
Beck Depression Inventory
Parental symptoms of depression
Management of Child Behavior Scale
Parenting practices
Parent-Therapist Relationship Scale (Therapist version)
Characteristics of the therapeutic relationship according to therapist report
Parent-Therapist Relationship Scale (Therapist version)
Characteristics of the therapeutic relationship according to therapist report
Parent-Therapist Relationship Scale (Parent version)
Characteristics of the therapeutic relationship according to parent report
Parent-Therapist Relationship Scale (Parent version)
Characteristics of the therapeutic relationship according to parent report
Barriers to Participation in Treatment (Therapist version)
Stressors and obstacles that interfere with treatment
Barriers to Participation in Treatment (Therapist version)
Stressors and obstacles that interfere with treatment
Barriers to Participation in Treatment (Parent version)
Stressors and obstacles that interfere with treatment
Barriers to Participation in Treatment (Parent version)
Stressors and obstacles that interfere with treatment
Weekly Participation in Treatment
Attendance and participation in treatment sessions
Treatment Adherence Inventory (Therapist version)
Parental compliance with specific treatment techniques
Treatment Adherence Inventory (Therapist version)
Parental compliance with specific treatment techniques
Treatment Adherence Inventory (Parent version)
Parental compliance with specific treatment techniques
Treatment Adherence Inventory (Parent version)
Parental compliance with specific treatment techniques
Therapist Evaluation Inventory
Acceptability of treatment based on therapist report
Therapist Evaluation Inventory
Acceptability of treatment based on therapist report
Parent Evaluation Inventory
Acceptability of treatment based on parent report
Parent Evaluation Inventory
Acceptability of treatment based on parent report
Acceptability of Treatment Modality
Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically
Acceptability of Treatment Modality
Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically
Full Information
NCT ID
NCT01822392
First Posted
March 22, 2013
Last Updated
February 4, 2015
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01822392
Brief Title
On-line Treatment for Conduct Problems
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder, Oppositional Defiant Disorder
Keywords
Online treatment, Treatment of conduct problems, Parent training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online treatment, High therapist contact
Arm Type
Active Comparator
Arm Description
Participants receive online Parent Management Training (interactive).
Arm Title
Online treatment, Low therapist contact
Arm Type
Experimental
Arm Description
Participants receive online Parent Management Training (recorded).
Intervention Type
Behavioral
Intervention Name(s)
Online Parent Management Training (Interactive)
Intervention Type
Behavioral
Intervention Name(s)
Online Parent Management Training (Recorded)
Primary Outcome Measure Information:
Title
Child Behavior Checklist
Description
Internalizing and externalizing behavior problems in children
Time Frame
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
Title
Child Global Assessment Scale
Description
Therapist-rated measure of overall child impairment and functioning
Time Frame
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
Title
Interview for Antisocial Behavior
Description
Presence of a broad range of overt and covert antisocial behaviors in children
Time Frame
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
Title
Research Diagnostic Interview
Description
Clinical symptoms and diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
Time Frame
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
Secondary Outcome Measure Information:
Title
Parenting Stress Index
Description
Sources of stress for the parent
Time Frame
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
Title
Beck Depression Inventory
Description
Parental symptoms of depression
Time Frame
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
Title
Management of Child Behavior Scale
Description
Parenting practices
Time Frame
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
Title
Parent-Therapist Relationship Scale (Therapist version)
Description
Characteristics of the therapeutic relationship according to therapist report
Time Frame
Midtreatment (Week 4 of treatment)
Title
Parent-Therapist Relationship Scale (Therapist version)
Description
Characteristics of the therapeutic relationship according to therapist report
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Title
Parent-Therapist Relationship Scale (Parent version)
Description
Characteristics of the therapeutic relationship according to parent report
Time Frame
Midtreatment (Week 4 of treatment)
Title
Parent-Therapist Relationship Scale (Parent version)
Description
Characteristics of the therapeutic relationship according to parent report
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Title
Barriers to Participation in Treatment (Therapist version)
Description
Stressors and obstacles that interfere with treatment
Time Frame
Midtreatment (Week 4 of treatment)
Title
Barriers to Participation in Treatment (Therapist version)
Description
Stressors and obstacles that interfere with treatment
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Title
Barriers to Participation in Treatment (Parent version)
Description
Stressors and obstacles that interfere with treatment
Time Frame
Midtreatment (Week 4 of treatment)
Title
Barriers to Participation in Treatment (Parent version)
Description
Stressors and obstacles that interfere with treatment
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Title
Weekly Participation in Treatment
Description
Attendance and participation in treatment sessions
Time Frame
Weekly (during treatment)
Title
Treatment Adherence Inventory (Therapist version)
Description
Parental compliance with specific treatment techniques
Time Frame
Midtreatment (Week 4 of treatment)
Title
Treatment Adherence Inventory (Therapist version)
Description
Parental compliance with specific treatment techniques
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Title
Treatment Adherence Inventory (Parent version)
Description
Parental compliance with specific treatment techniques
Time Frame
Midtreatment (Week 4 of treatment)
Title
Treatment Adherence Inventory (Parent version)
Description
Parental compliance with specific treatment techniques
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Title
Therapist Evaluation Inventory
Description
Acceptability of treatment based on therapist report
Time Frame
Midtreatment (Week 4 of treatment)
Title
Therapist Evaluation Inventory
Description
Acceptability of treatment based on therapist report
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Title
Parent Evaluation Inventory
Description
Acceptability of treatment based on parent report
Time Frame
Midtreatment (Week 4 of treatment)
Title
Parent Evaluation Inventory
Description
Acceptability of treatment based on parent report
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Title
Acceptability of Treatment Modality
Description
Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically
Time Frame
Midtreatment (Week 4 of treatment)
Title
Acceptability of Treatment Modality
Description
Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
Other Pre-specified Outcome Measures:
Title
Perspectives on Treatment Interview
Description
Open-ended interview questions about parents' experiences in treatment and their impressions of different aspects of online treatment delivery
Time Frame
Posttreatment (immediately after treatment is completed; Week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan E. Kazdin, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Parenting Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Learn more about this trial
On-line Treatment for Conduct Problems
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