Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-06-14 @ 7:00 PM
Study NCT ID:
NCT02629133
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intervention for Battered Sheltered Women With Substance Use Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'czlotnick@butler.org', 'phone': '401-474-3332', 'title': 'Caron Zlotnick', 'organization': 'Womene and Infants Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from baseline to 6 months after the participant left the shelter--varies from 6 months to 1 1/2 years depending on the participant.', 'description': 'In addition, the DSMB also included possible partner violence due to a child welfare report made by study participant and/or study staff (if have children) during the duration of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.\n\nSHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants\' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 16}], 'seriousEvents': [{'term': 'Hospitalization-general medical issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization-IPV related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization-inpatient-psyc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 16, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IPV-sought no medical care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IPV-emergency room visit only', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.\n\nSHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants\' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': '3 months post-shelter', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': '6 months post-shelter', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.560', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.760', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Differences between conditions in the change in % heavy drinking/using days from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed at baseline, and at 3 and 6 months post shelter', 'description': 'The computer-based TLFB will assess drug use and heavy drinking (4+ standard drinks) days for the past week and the past 90 days. For primary analysis, days using drugs and heavy drinking days will be combined to create a single variable that reflects the total number of days that women used drugs or had 4+ drinks. The primary outcome is substance use (heavy drinking or drug using) days over a 6 month post shelter period. We are assessing the change of this number from baseline to 3 months post shelter, and from baseline 6 months post shelter.', 'unitOfMeasure': '% days of drug use or heavy drinking', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Treatment Services Review (TSR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.\n\nSHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants\' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': '3 months post-shelter', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': '6 months post-shelter', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Distributions were badly skewed, and the sample was too small for ZINB or other analyses. Therefore, we analyzed differences between conditions in changes in services/day over time (i.e., from baseline to 6 month post-shelter follow-up) using the Mann-Whitney U.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed at baseline, and again at 3 and 6 months later', 'description': 'The Treatment Services Review will be used to assess total times using substance use services (both treatment and self-help utilization) received (including outpatient, day patient, residential treatment, NA, AA) to capture the extent to which women are reaching out to access recovery-related resources. The TSR will assess number of times attending substance use services, divided by the number of days in the reporting period.', 'unitOfMeasure': 'times using substance use services/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Composite Abuse Scale (CAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.\n\nSHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants\' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.8', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '74.4', 'spread': '40.5', 'groupId': 'OG001'}]}]}, {'title': '3 months post-shelter', 'categories': [{'measurements': [{'value': '9.4', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '32.8', 'groupId': 'OG001'}]}]}, {'title': '6 months post-shelter', 'categories': [{'measurements': [{'value': '14.1', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '13.5', 'pValueComment': 'We used hierarchical linear modeling (HLM) to predict 3-mo and 6-mo post-shelter scores from treatment condition, using baseline score as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, and again at 3 and 6 months after shelter release', 'description': 'The CAS is a widely used self-report of behaviors scale with 4 subscales that measure severe, combined abuse, emotional abuse, physical abuse, and harassment. The CAS has recently been published in the Centers for Disease Control and Prevention compendium of intimate partner violence measures. It consists of 30 items presented in a six point format requiring respondents to answer "never", "only once", "several times", "monthly", "weekly" or "daily" in a twelve month period. Below we present the CAS victimization scores. Scores range from 0 to 145; higher scores are worse.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Cyber Stalking Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.\n\nSHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants\' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.53', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '7.39', 'spread': '4.29', 'groupId': 'OG001'}]}]}, {'title': '3 months post-shelter', 'categories': [{'measurements': [{'value': '4.95', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '4.45', 'groupId': 'OG001'}]}]}, {'title': '6 months post-shelter', 'categories': [{'measurements': [{'value': '3.89', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '3.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '2.98', 'pValueComment': 'We used HLM to predict Cyber-Stalking Scores across 3 and 6 month post shelter follow-up points from treatment condition, using baseline score as a covariate.', 'estimateComment': 'Higher scores represent more cyber-stalking over follow-up.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, and again at 3 and 6 months later', 'description': 'The Cyber Stalking Scale measure is a 6 -item measure and assesses the use of technologies in stalking and harassment. Scores range from 0 to 12. Lower is better (indicated less Cyber Stalking).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety Behavior Checklist (SBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.\n\nSHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants\' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': '3 months post-shelter', 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': '6 months post-shelter', 'categories': [{'measurements': [{'value': '2.8', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '5.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.119', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.43', 'ciLowerLimit': '-3.24', 'ciUpperLimit': '0.38', 'pValueComment': 'We conducted HLM predicting SBC Total scores at 3 and 6 months post-shelter release from treatment condition, using baseline SBC score as a covariate.', 'estimateComment': 'Higher is better (reflecting more safety behaviors used).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, and again at 3 and 6 months after shelter release', 'description': 'Safety Behavior Checklist (SBC) has 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Scores range from 0 to 15; higher scores are better (indicating more safety behaviors used).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.\n\nSHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants\' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.'}, {'id': 'FG001', 'title': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.\n\nSHE Program: The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants\' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.'}, {'id': 'BG001', 'title': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '35.2', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': '% drug using/heavy drinking days', 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '0.38', 'groupId': 'BG000'}, {'value': '0.66', 'spread': '0.38', 'groupId': 'BG001'}, {'value': '0.59', 'spread': '0.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '% drug using/heavy drinking days', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'NA - patient flow and assignment were as expected.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-15', 'size': 34717, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-06T11:39', 'hasProtocol': False}, {'date': '2017-03-15', 'size': 648509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-06T11:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2015-12-02', 'resultsFirstSubmitDate': '2019-02-26', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-06', 'studyFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version', 'timeFrame': 'Assessed at baseline, and at 3 and 6 months post shelter', 'description': 'The computer-based TLFB will assess drug use and heavy drinking (4+ standard drinks) days for the past week and the past 90 days. For primary analysis, days using drugs and heavy drinking days will be combined to create a single variable that reflects the total number of days that women used drugs or had 4+ drinks. The primary outcome is substance use (heavy drinking or drug using) days over a 6 month post shelter period. We are assessing the change of this number from baseline to 3 months post shelter, and from baseline 6 months post shelter.'}], 'secondaryOutcomes': [{'measure': 'The Treatment Services Review (TSR)', 'timeFrame': 'Assessed at baseline, and again at 3 and 6 months later', 'description': 'The Treatment Services Review will be used to assess total times using substance use services (both treatment and self-help utilization) received (including outpatient, day patient, residential treatment, NA, AA) to capture the extent to which women are reaching out to access recovery-related resources. The TSR will assess number of times attending substance use services, divided by the number of days in the reporting period.'}, {'measure': 'The Composite Abuse Scale (CAS)', 'timeFrame': 'Assessed at baseline, and again at 3 and 6 months after shelter release', 'description': 'The CAS is a widely used self-report of behaviors scale with 4 subscales that measure severe, combined abuse, emotional abuse, physical abuse, and harassment. The CAS has recently been published in the Centers for Disease Control and Prevention compendium of intimate partner violence measures. It consists of 30 items presented in a six point format requiring respondents to answer "never", "only once", "several times", "monthly", "weekly" or "daily" in a twelve month period. Below we present the CAS victimization scores. Scores range from 0 to 145; higher scores are worse.'}, {'measure': 'The Cyber Stalking Scale', 'timeFrame': 'Assessed at baseline, and again at 3 and 6 months later', 'description': 'The Cyber Stalking Scale measure is a 6 -item measure and assesses the use of technologies in stalking and harassment. Scores range from 0 to 12. Lower is better (indicated less Cyber Stalking).'}, {'measure': 'Safety Behavior Checklist (SBC)', 'timeFrame': 'Assessed at baseline, and again at 3 and 6 months after shelter release', 'description': 'Safety Behavior Checklist (SBC) has 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Scores range from 0 to 15; higher scores are better (indicating more safety behaviors used).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intimate Partner Violence', 'Sheltered Battered Women', 'Substance Use'], 'conditions': ['Intimate Partner Violence']}, 'descriptionModule': {'briefSummary': 'This study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Safe and Healthy Experiences; The SHE Program) that addresses known barriers in early identification and intervention with sheltered battered women with IPV (intimate partner violence) and substance use.', 'detailedDescription': "Intimate partner violence (IPV) and substance use are significant and interconnected public health problems facing women. For battered women, the presence of substance use increases the risk of revictimization and the risk of more severe abuse. Battered women's shelters provide emergency shelter to approximately 300,000 women and children each year. A prime time to intervene with battered women might be when they enter a shelter and have already initiated a change in their lives. A shelter-based intervention for battered women that addresses substance use problems might reduce the risk of substance use, reduce the risk of future IPV, and improve utilization of substance use treatment and community resources. The objective of this R34 Award was to develop and assess an innovative, easily implementable, low-cost, computer-delivered intervention, the SHE Program (Safe and Healthy Experiences) that addresses known barriers in early identification and intervention for battered sheltered women with substance use issues. SHE is based on motivational interviewing (MI) a well-defined intervention strategy that has yielded particularly promising results in a range of clinical issues and a range of patient populations, including substance using women. MI is consistent with an empowerment model, which is a highly recommended intervention model for victimized women. The R34 had two distinct phases to assess the SHE Program with battered sheltered women with substance use issues. During the Development Phase, the research team conducted focus groups and developed the intervention to meet the needs of our target group, developed the software for the computer-delivered intervention, and conducted an open trial with 10 participants. During the Pilot Study Phase, the investigators conducted a two-group, randomized controlled study with a sample of 50 battered sheltered women who reported substance use difficulties within the last three months, which provides the necessary groundwork to examine the efficacy of the SHE Program in a future, large clinical trial. The SHE Program was found to be feasible, acceptable and efficacious in improving outcomes for our vulnerable target population. The program has the potential to be widely disseminated while maintaining treatment fidelity across battered women shelters and may hold promise for IPV populations with substance use difficulties in other settings."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women who are 18 or older, residents of a battered women's shelter, who are at risk substance users within the last 3 months as determined by the screener, the NIDA-Modified ASSIST, and endorse IPV within the last 3 months as determined by the screener, the WAST (Woman Abuse Screening Tool)\n\nExclusion Criteria:\n\n* Inability to provide informed consent (e.g., due to florid psychosis or other clear cognitive impairment)\n* Inability to understand English"}, 'identificationModule': {'nctId': 'NCT02629133', 'briefTitle': 'Intervention for Battered Sheltered Women With Substance Use Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'Women and Infants Hospital of Rhode Island'}, 'officialTitle': 'Computer-Based Intervention for Battered Sheltered Women With Substance Use Randomized Trial', 'orgStudyIdInfo': {'id': '792696'}, 'secondaryIdInfos': [{'id': 'R34DA038770-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R34DA038770-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHE Program', 'description': 'Participants received a 50 minute intervention on the computer immediately after their baseline assessment and a 15 minute "booster" session on the computer within 2 weeks after the intervention. There was also a 3 and 6 month follow-up after completion of the SHE program.', 'interventionNames': ['Behavioral: SHE Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Condition', 'description': 'Control condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for rating of subjective preference. Participants in this condition completed a baseline assessment as well as a television show booster and a follow-up assessment 3 and 6 months later.'}], 'interventions': [{'name': 'SHE Program', 'type': 'BEHAVIORAL', 'description': "The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.", 'armGroupLabels': ['SHE Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02703', 'city': 'Attleboro', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New Hope', 'geoPoint': {'lat': 41.94454, 'lon': -71.28561}}, {'zip': '44305', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Battered Women's Shelter of Summit and Medina Counties", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Center for Women's Behavioral Health at Women and Infants' Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02895', 'city': 'Woonsocket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Sojourner House', 'geoPoint': {'lat': 42.00288, 'lon': -71.51478}}], 'overallOfficials': [{'name': 'Caron Zlotnick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Women and Infants' Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Women and Infants Hospital of Rhode Island', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Behavioral Medicine Research', 'investigatorFullName': 'Caron Zlotnick', 'investigatorAffiliation': 'Women and Infants Hospital of Rhode Island'}}}}