On-line Treatment for Conduct Problems

Conduct Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822392
• Other study ID #: 1108008914
• Secondary ID: 1R34MH093326-01A
• Status: Completed
• Phase: N/A
• First received: March 22, 2013
• Last updated: February 4, 2015
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Conduct Disorder
• Disease
• Oppositional Defiant Disorder

Intervention

Behavioral:
• Online Parent Management Training (Interactive)

• Online Parent Management Training (Recorded)

Locations

Country	Name	City	State
United States	Yale Parenting Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perspectives on Treatment Interview	Open-ended interview questions about parents' experiences in treatment and their impressions of different aspects of online treatment delivery	Posttreatment (immediately after treatment is completed; Week 8)	No
Primary	Child Behavior Checklist	Internalizing and externalizing behavior problems in children	Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)	No
Primary	Child Global Assessment Scale	Therapist-rated measure of overall child impairment and functioning	Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)	No
Primary	Interview for Antisocial Behavior	Presence of a broad range of overt and covert antisocial behaviors in children	Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)	No
Primary	Research Diagnostic Interview	Clinical symptoms and diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria	Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Parenting Stress Index	Sources of stress for the parent	Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Beck Depression Inventory	Parental symptoms of depression	Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Management of Child Behavior Scale	Parenting practices	Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Parent-Therapist Relationship Scale (Therapist version)	Characteristics of the therapeutic relationship according to therapist report	Midtreatment (Week 4 of treatment)	No
Secondary	Parent-Therapist Relationship Scale (Therapist version)	Characteristics of the therapeutic relationship according to therapist report	Posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Parent-Therapist Relationship Scale (Parent version)	Characteristics of the therapeutic relationship according to parent report	Midtreatment (Week 4 of treatment)	No
Secondary	Parent-Therapist Relationship Scale (Parent version)	Characteristics of the therapeutic relationship according to parent report	Posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Barriers to Participation in Treatment (Therapist version)	Stressors and obstacles that interfere with treatment	Midtreatment (Week 4 of treatment)	No
Secondary	Barriers to Participation in Treatment (Therapist version)	Stressors and obstacles that interfere with treatment	Posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Barriers to Participation in Treatment (Parent version)	Stressors and obstacles that interfere with treatment	Midtreatment (Week 4 of treatment)	No
Secondary	Barriers to Participation in Treatment (Parent version)	Stressors and obstacles that interfere with treatment	Posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Weekly Participation in Treatment	Attendance and participation in treatment sessions	Weekly (during treatment)	No
Secondary	Treatment Adherence Inventory (Therapist version)	Parental compliance with specific treatment techniques	Midtreatment (Week 4 of treatment)	No
Secondary	Treatment Adherence Inventory (Therapist version)	Parental compliance with specific treatment techniques	Posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Treatment Adherence Inventory (Parent version)	Parental compliance with specific treatment techniques	Midtreatment (Week 4 of treatment)	No
Secondary	Treatment Adherence Inventory (Parent version)	Parental compliance with specific treatment techniques	Posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Therapist Evaluation Inventory	Acceptability of treatment based on therapist report	Midtreatment (Week 4 of treatment)	No
Secondary	Therapist Evaluation Inventory	Acceptability of treatment based on therapist report	Posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Parent Evaluation Inventory	Acceptability of treatment based on parent report	Midtreatment (Week 4 of treatment)	No
Secondary	Parent Evaluation Inventory	Acceptability of treatment based on parent report	Posttreatment (immediately after treatment is completed; Week 8)	No
Secondary	Acceptability of Treatment Modality	Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically	Midtreatment (Week 4 of treatment)	No
Secondary	Acceptability of Treatment Modality	Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically	Posttreatment (immediately after treatment is completed; Week 8)	No