Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-28 @ 8:51 AM
Study NCT ID:
NCT01822392
Status:
COMPLETED
Last Update Posted:
2015-02-06
First Post:
2013-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
On-line Treatment for Conduct Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019955', 'term': 'Conduct Disorder'}, {'id': 'D000096865', 'term': 'Oppositional Defiant Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004347', 'term': 'Drug Interactions'}], 'ancestors': [{'id': 'D000069437', 'term': 'Pharmacological Phenomena'}, {'id': 'D002620', 'term': 'Pharmacological and Toxicological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-04', 'studyFirstSubmitDate': '2013-03-22', 'studyFirstSubmitQcDate': '2013-03-27', 'lastUpdatePostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Perspectives on Treatment Interview', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': "Open-ended interview questions about parents' experiences in treatment and their impressions of different aspects of online treatment delivery"}], 'primaryOutcomes': [{'measure': 'Child Behavior Checklist', 'timeFrame': 'Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Internalizing and externalizing behavior problems in children'}, {'measure': 'Child Global Assessment Scale', 'timeFrame': 'Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Therapist-rated measure of overall child impairment and functioning'}, {'measure': 'Interview for Antisocial Behavior', 'timeFrame': 'Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Presence of a broad range of overt and covert antisocial behaviors in children'}, {'measure': 'Research Diagnostic Interview', 'timeFrame': 'Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Clinical symptoms and diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria'}], 'secondaryOutcomes': [{'measure': 'Parenting Stress Index', 'timeFrame': 'Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Sources of stress for the parent'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Parental symptoms of depression'}, {'measure': 'Management of Child Behavior Scale', 'timeFrame': 'Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Parenting practices'}, {'measure': 'Parent-Therapist Relationship Scale (Therapist version)', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Characteristics of the therapeutic relationship according to therapist report'}, {'measure': 'Parent-Therapist Relationship Scale (Therapist version)', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Characteristics of the therapeutic relationship according to therapist report'}, {'measure': 'Parent-Therapist Relationship Scale (Parent version)', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Characteristics of the therapeutic relationship according to parent report'}, {'measure': 'Parent-Therapist Relationship Scale (Parent version)', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Characteristics of the therapeutic relationship according to parent report'}, {'measure': 'Barriers to Participation in Treatment (Therapist version)', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Stressors and obstacles that interfere with treatment'}, {'measure': 'Barriers to Participation in Treatment (Therapist version)', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Stressors and obstacles that interfere with treatment'}, {'measure': 'Barriers to Participation in Treatment (Parent version)', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Stressors and obstacles that interfere with treatment'}, {'measure': 'Barriers to Participation in Treatment (Parent version)', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Stressors and obstacles that interfere with treatment'}, {'measure': 'Weekly Participation in Treatment', 'timeFrame': 'Weekly (during treatment)', 'description': 'Attendance and participation in treatment sessions'}, {'measure': 'Treatment Adherence Inventory (Therapist version)', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Parental compliance with specific treatment techniques'}, {'measure': 'Treatment Adherence Inventory (Therapist version)', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Parental compliance with specific treatment techniques'}, {'measure': 'Treatment Adherence Inventory (Parent version)', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Parental compliance with specific treatment techniques'}, {'measure': 'Treatment Adherence Inventory (Parent version)', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Parental compliance with specific treatment techniques'}, {'measure': 'Therapist Evaluation Inventory', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Acceptability of treatment based on therapist report'}, {'measure': 'Therapist Evaluation Inventory', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Acceptability of treatment based on therapist report'}, {'measure': 'Parent Evaluation Inventory', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Acceptability of treatment based on parent report'}, {'measure': 'Parent Evaluation Inventory', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Acceptability of treatment based on parent report'}, {'measure': 'Acceptability of Treatment Modality', 'timeFrame': 'Midtreatment (Week 4 of treatment)', 'description': 'Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically'}, {'measure': 'Acceptability of Treatment Modality', 'timeFrame': 'Posttreatment (immediately after treatment is completed; Week 8)', 'description': 'Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Online treatment', 'Treatment of conduct problems', 'Parent training'], 'conditions': ['Conduct Disorder', 'Oppositional Defiant Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Conduct Disorder of Oppositional Defiant Disorder (for the child)\n* Residence in the state of CT\n* Access to a computer and high-speed Internet access\n* English fluency (at least one parent)\n* No history of significant developmental delay (for the child)\n* Parental consent\n\nExclusion Criteria:\n\n* Participation in another form of psychotherapy or counseling that is directed toward the reduction of social, emotional, or behavioral problems\n* Evidence of recent suicidality (for the child)\n* Current or lifetime diagnosis of a Pervasive Developmental Disorder\n* Primary diagnoses of a mood or anxiety disorder\n* Acute family crisis\n* Parent or guardian who can participate in treatment shows current psychosis or an uncontrolled medical condition'}, 'identificationModule': {'nctId': 'NCT01822392', 'briefTitle': 'On-line Treatment for Conduct Problems', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'orgStudyIdInfo': {'id': '1108008914'}, 'secondaryIdInfos': [{'id': '1R34MH093326-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R34MH093326-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Online treatment, High therapist contact', 'description': 'Participants receive online Parent Management Training (interactive).', 'interventionNames': ['Behavioral: Online Parent Management Training (Interactive)']}, {'type': 'EXPERIMENTAL', 'label': 'Online treatment, Low therapist contact', 'description': 'Participants receive online Parent Management Training (recorded).', 'interventionNames': ['Behavioral: Online Parent Management Training (Recorded)']}], 'interventions': [{'name': 'Online Parent Management Training (Interactive)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Online treatment, High therapist contact']}, {'name': 'Online Parent Management Training (Recorded)', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Online treatment, Low therapist contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Parenting Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Alan E. Kazdin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alan E. Kazdin', 'investigatorAffiliation': 'Yale University'}}}}