Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-26 @ 3:09 AM
Study NCT ID:
NCT00402857
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2006-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D000096865', 'term': 'Oppositional Defiant Disorder'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-11', 'studyFirstSubmitDate': '2006-11-20', 'studyFirstSubmitQcDate': '2006-11-20', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parenting behavior', 'timeFrame': 'Measured post-intervention and at 6- and 12-month follow-ups'}, {'measure': 'Child disruptive behaviors', 'timeFrame': 'Measured post-intervention and at 6- and 12-month follow-ups'}], 'secondaryOutcomes': [{'measure': 'Child and parent functional status/impairment', 'timeFrame': 'Measured post-intervention and at 6- and 12-month follow-ups'}, {'measure': 'Parenting stress', 'timeFrame': 'Measured post-intervention and at 6- and 12-month follow-ups'}, {'measure': 'Family functioning', 'timeFrame': 'Measured post-intervention and at 6- and 12-month follow-ups'}, {'measure': 'Consumer perspectives', 'timeFrame': 'Measured post-intervention and at 6- and 12-month follow-ups'}, {'measure': 'Cost of services', 'timeFrame': 'Measured post-intervention and at 6- and 12-month follow-ups'}, {'measure': 'Barriers to treatment', 'timeFrame': 'Measured post-intervention and at 6- and 12-month follow-ups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parenting Education', 'Child, Preschool', 'Preventive Intervention', 'Primary Health Care', 'Pediatrics', 'Attention Deficit Disorders', 'Oppositional Defiant Disorder', 'Disruptive Behavior Disorder'], 'conditions': ['Attention Deficit Disorder With Hyperactivity', 'Attention Deficit and Disruptive Behavior Disorders']}, 'referencesModule': {'references': [{'pmid': '24190691', 'type': 'DERIVED', 'citation': 'Perrin EC, Sheldrick RC, McMenamy JM, Henson BS, Carter AS. Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial. JAMA Pediatr. 2014 Jan;168(1):16-24. doi: 10.1001/jamapediatrics.2013.2919.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.', 'detailedDescription': "Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) are common childhood behavior disorders. Children with ADHD experience hyperactivity, distractibility, poor concentration, and impulsivity. If left untreated, ADHD can continue into adulthood, and can cause problems in family, social, and work environments. Children with ODD exhibit an ongoing pattern of uncooperative, defiant, and hostile behavior toward authority figures. Symptoms of ODD, including frequent temper tantrums, anger, resentment, and vindictiveness, may interfere with a child's everyday functioning. The Incredible Years parent training program has been shown to be effective in multiple settings at training parents to manage their child's behavior. This study will evaluate the effectiveness of the Incredible Years training program within a pediatric office setting at improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.\n\nParticipants in this open-label study will be randomly assigned to the Incredible Years training program or a waitlist condition, in which they will begin the program after a 1-year waiting period. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs. Self-report assessments and phone interviews will be used to assess outcomes. Additionally, follow-up visits will occur immediately post-intervention and 6 and 12 months post-intervention. Children will attend one visit before the program begins, as well as the follow-ups held immediately post-intervention and 12 months post-intervention. These visits will include videotaped observations of children and their primary caregivers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '38 Months', 'minimumAge': '22 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParent or primary caregiver of a child who fits the following criteria:\n\n* Receives a positive result on behavioral screening\n\nExclusion Criteria:\n\nParent or primary caregiver of a child who fits the following criteria:\n\n* Diagnosis of pervasive developmental disorder or global developmental delay'}, 'identificationModule': {'nctId': 'NCT00402857', 'briefTitle': 'Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'Advanced Parenting Education in Pediatrics: The APEP Project', 'orgStudyIdInfo': {'id': 'R01MH076244', 'link': 'https://reporter.nih.gov/quickSearch/R01MH076244', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH076244', 'link': 'https://reporter.nih.gov/quickSearch/R01MH076244', 'type': 'NIH'}, {'id': 'DSIR CT-C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive the Incredible Years Program, a group parenting intervention', 'interventionNames': ['Behavioral: Incredible Years Program']}, {'type': 'OTHER', 'label': '2', 'description': 'Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period', 'interventionNames': ['Behavioral: Incredible Years Program']}], 'interventions': [{'name': 'Incredible Years Program', 'type': 'BEHAVIORAL', 'description': 'The Incredible Years Program is a 10-week group parenting intervention. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chelsea', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MGH Chelsea Healthcare Center', 'geoPoint': {'lat': 42.39176, 'lon': -71.03283}}, {'zip': '02124', 'city': 'Dorchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Codman Square Health Center', 'geoPoint': {'lat': 42.29732, 'lon': -71.0745}}, {'zip': '02130', 'city': 'Jamaica Plain', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Martha Eliot Health Center', 'geoPoint': {'lat': 42.30982, 'lon': -71.12033}}, {'zip': '01453', 'city': 'Leominster', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Medical Associates Pediatrics', 'geoPoint': {'lat': 42.52509, 'lon': -71.75979}}, {'zip': '01772', 'city': 'Southborough', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Southboro Medical Group', 'geoPoint': {'lat': 42.30565, 'lon': -71.52451}}, {'zip': '01886', 'city': 'Westford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pediatrics West', 'geoPoint': {'lat': 42.57926, 'lon': -71.43784}}, {'zip': '02090', 'city': 'Westwood', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Westwood-Mansfield Pediatric Associates', 'geoPoint': {'lat': 42.21399, 'lon': -71.2245}}, {'zip': '01887', 'city': 'Wilmington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Wilmington Pediatrics', 'geoPoint': {'lat': 42.54648, 'lon': -71.17367}}, {'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Woburn Pediatric Associates', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}], 'overallOfficials': [{'name': 'Ellen C. Perrin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}, {'name': 'Christopher Sheldrick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center'}, {'name': 'Jannette McMenamy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fitchburg State College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}