Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-27 @ 1:30 PM
Study NCT ID:
NCT00056303
Status:
COMPLETED
Last Update Posted:
2016-12-20
First Post:
2003-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Health Services for Foster and Adopted Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000066553', 'term': 'Problem Behavior'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2003-03-10', 'studyFirstSubmitQcDate': '2003-03-10', 'lastUpdatePostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attachment', 'timeFrame': 'Annually', 'description': 'The Preschool Strange Situation is conducted annually.'}], 'secondaryOutcomes': [{'measure': 'Executive Functioning', 'timeFrame': 'Annually', 'description': 'Disruptive Behaviors-Diagnostic Observation Schedule (DB-DOS) is used to assess problem behaviors. The DB-DOS consists of a series of challenging tasks that ask the child to inhibit prepotent behaviors and regulate emotions.'}, {'measure': 'Diurnal production of cortisol', 'timeFrame': 'Annually', 'description': 'Three days of saliva sampling at wake-up and bedtime.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Attachment', 'Intervention', 'Prevention'], 'conditions': ['Problem Behaviors', 'Attention Deficit Hyperactivity Disorder', 'Depression']}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.', 'detailedDescription': "Infants and toddlers who are placed into foster or adoptive care often exhibit a number of behavioral, emotional, and physiological problems. In the absence of specialized services, problems in the relationship between caregiver and child may develop; problems in the child's functioning often persist and are exacerbated. This study will attempt to alleviate the attachment and regulatory difficulties that affect many young children placed into care.\n\nChildren are randomly assigned to either an experimental group or to a treatment control group for 3 years. The experimental group focuses on relational issues; the control group focuses on cognitive development. Caregivers receiving the relational intervention are trained to provide nurturing care, and to help children learn to develop adequate regulatory skills. Caregivers in the treatment control group receive training designed to enhance children's cognitive development. Caregivers in both groups will receive 10 home visits. Observations of children and parents are used to assess participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '20 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Toddler placed into foster care\n* Resident of Delaware and surrounding counties in Pennsylvania and Maryland\n\nExclusion Criteria:\n\n* Significant medical problems'}, 'identificationModule': {'nctId': 'NCT00056303', 'briefTitle': 'Mental Health Services for Foster and Adopted Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'Specialized Mental Health Services for Foster Infants', 'orgStudyIdInfo': {'id': 'R01MH052135', 'link': 'https://reporter.nih.gov/quickSearch/R01MH052135', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH052135', 'link': 'https://reporter.nih.gov/quickSearch/R01MH052135', 'type': 'NIH'}, {'id': 'DSIR 84-CTCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attachment and Biobehavioral Catch-up', 'description': 'Attachment and Biobehavioral Catch-up targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers.', 'interventionNames': ['Behavioral: Attachment and Biobehavioral Catch-up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Developmental Education for Families', 'description': 'Developmental Education for Families targets providing cognitive stimulation to their children.', 'interventionNames': ['Behavioral: Developmental Education for Families']}], 'interventions': [{'name': 'Attachment and Biobehavioral Catch-up', 'type': 'BEHAVIORAL', 'description': 'Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.', 'armGroupLabels': ['Attachment and Biobehavioral Catch-up']}, {'name': 'Developmental Education for Families', 'type': 'BEHAVIORAL', 'description': "Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.", 'armGroupLabels': ['Developmental Education for Families']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19716', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'University of Delaware', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'Mary Dozier, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'UNIDEL-Amy E dupont Professor, Psychology', 'investigatorFullName': 'Mary Dozier', 'investigatorAffiliation': 'University of Delaware'}}}}