Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 4:37 PM
Study NCT ID:
NCT01188434
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2010-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating Interventions for Maternal Substance Abuse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2010-08-23', 'studyFirstSubmitQcDate': '2010-08-23', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Addiction Severity Index', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'self report of all substances used'}, {'measure': 'Service Utilization Survey', 'timeFrame': 'monthly', 'description': 'self report of social, medical, and mental health services received by parent and youth'}, {'measure': 'Parenting Measures', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Assessment battery of parenting beliefs, expectations, and behaviors'}], 'secondaryOutcomes': [{'measure': 'Urinalysis', 'timeFrame': 'monthly', 'description': '10 panel Urine Drug Screen Collection'}, {'measure': 'Archival data from the Child Welfare system', 'timeFrame': 'annually', 'description': 'System level data of new reports to the child welfare system'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Methamphetamine', 'Substance Abuse', 'Child Neglect', 'Child Welfare', 'Evidence Based Practice'], 'conditions': ['Substance Abuse', 'Child Neglect']}, 'descriptionModule': {'briefSummary': 'This Research Plan proposes Stage 1 Research integrating evidence based practices to address the needs of mothers referred to child welfare for substance abuse. Mothers with a history of methamphetamine abuse and child neglect will be recruited. Using an intensive community based treatment, mothers will receive substance abuse treatment combined with parenting skills training and psychosocial support for basic needs (e.g., housing, employment). This project will include a feasibility study (n = 5), followed by a small randomized pilot (n = 24) to examine the efficacy of the Integrated Treatment for Substance Abuse and Neglect compared to treatment as usual, with a population of substance abusing neglectful mothers referred through the Department of Child Welfare.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal Substance Abuse\n* Child Welfare involvement\n* Child Neglect\n* English Speaking\n* Child either remaining in the home or reunification plan in place\n* Living in the county\n\nExclusion Criteria:\n\n* Current involvement in other substance abuse treatment\n* Current involvement in other parenting skills training\n* parental rights terminated\n* active psychosis'}, 'identificationModule': {'nctId': 'NCT01188434', 'acronym': 'ITSAN', 'briefTitle': 'Integrating Interventions for Maternal Substance Abuse', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Social Learning Center'}, 'officialTitle': 'Integrating Interventions for Maternal Substance Abuse and Child Neglect', 'orgStudyIdInfo': {'id': 'K23DA021603', 'link': 'https://reporter.nih.gov/quickSearch/K23DA021603', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrated Behavioral Treatment', 'description': 'Combined substance abuse, parenting skills, and basic needs intervention', 'interventionNames': ['Behavioral: ITSAN']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'casework treatment as usual', 'description': 'services as usual as referred by child welfare', 'interventionNames': ['Behavioral: Services as Usual']}], 'interventions': [{'name': 'ITSAN', 'type': 'BEHAVIORAL', 'description': 'integrated behavioral intervention for substance abuse, parenting skills, and basic needs', 'armGroupLabels': ['Integrated Behavioral Treatment']}, {'name': 'Services as Usual', 'type': 'BEHAVIORAL', 'description': 'Services as usual referred by child welfare', 'armGroupLabels': ['casework treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'OSLC', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Lisa Saldana, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSLC Community Programs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Social Learning Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Lisa Saldana', 'investigatorAffiliation': 'Oregon Social Learning Center'}}}}