Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT02370394
Status:
COMPLETED
Last Update Posted:
2018-06-04
First Post:
2015-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intervention for IPV Perinatal Women- RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CZlotnick@Butler.org', 'phone': '(401) 455-6529', 'title': 'Caron Zlotnick, Ph.D.', 'organization': 'Butler Hospital/Women and Infants Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': "Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.", 'description': 'The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'ROSE Program', 'description': 'Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.\n\nROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Hospitalization-general medical issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization-inpatient-psyc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'IPV-no medical care', 'notes': 'Physical abuse or rape - no medical care sought for injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'IPV related emergency room visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Abuse Scale (CAS)-CAS Victimization Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROSE Program', 'description': 'Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.\n\nROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.'}, {'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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.'}], 'classes': [{'title': 'CAS at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.36', 'spread': '17.81', 'groupId': 'OG000'}, {'value': '16.56', 'spread': '12.25', 'groupId': 'OG001'}]}]}, {'title': 'CAS at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.38', 'spread': '12.44', 'groupId': 'OG000'}, {'value': '16.52', 'spread': '20.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.14', 'ciLowerLimit': '-14.02', 'ciUpperLimit': '5.75', 'groupDescription': 'CAS Victimization Total Score at Follow Up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Unequal variances handled by Satterthwaite's degrees of freedom"}, {'pValue': '0.0072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.46', 'ciLowerLimit': '4.11', 'ciUpperLimit': '24.82', 'groupDescription': 'Change in CAS Victimization Total score from Baseline to Follow Up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': 'A widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.'}, {'type': 'PRIMARY', 'title': 'Safety Behavior Checklist (SBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROSE Program', 'description': 'Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.\n\nROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.'}, {'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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later..'}], 'classes': [{'title': 'SBC at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.28', 'spread': '.23', 'groupId': 'OG000'}, {'value': '.36', 'spread': '.23', 'groupId': 'OG001'}]}]}, {'title': 'SBC at Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.28', 'spread': '.28', 'groupId': 'OG000'}, {'value': '.32', 'spread': '.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.12', 'groupDescription': 'Safety Behavior Change Score at Follow Up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.15', 'groupDescription': 'Change is Safety Behavior Change Score from Baseline to Follow Up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': 'Includes 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Items were scored as Yes=1 or No=0 or Not applicable. Scale range is from 0-15. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more use of safety behaviors.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.'}, {'type': 'PRIMARY', 'title': 'Effectiveness in Obtaining Resources Scale (EOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROSE Program', 'description': 'Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.\n\nROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.'}, {'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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.'}], 'classes': [{'title': 'EOR at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.46', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '3.48', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'EOR at Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '2.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8646', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '1.36', 'groupDescription': 'EOR Number of issues Effective at Accomplishing at Follow Up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': "Unequal variances handled by Satterthwaite's degrees of freedom"}, {'pValue': '0.3045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '0.82', 'groupDescription': 'Change in Number of Issues Effective at Accomplishing from Baseline to Follow Up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': "Assesses the women's effectiveness in obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services. Items were scored as Yes=1 or No=0. Scale range is from 0-11. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more they were effective in obtaining resources.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.'}, {'type': 'SECONDARY', 'title': 'Motivation Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROSE Program', 'description': 'Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.\n\nROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.'}, {'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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.'}], 'classes': [{'title': 'Motivation Scale at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.18', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '7.52', 'spread': '3.48', 'groupId': 'OG001'}]}]}, {'title': 'Motivation Scale at Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.81', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '7.22', 'spread': '3.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9085', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Motivation Scale at Follow Up', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3256', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Motivation Scale from Baseline to Follow Up', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': 'A 1-item measure, was modified to assess how ready they are to use treatment, resources, and/or support for any partner abuse. This item was scored with a range from 0-10. 0=not ready at all to 10=completely ready. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to use treatment, resources, or support for any partner abuse.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.'}, {'type': 'SECONDARY', 'title': 'The Readiness to Change Contemplation Ladder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROSE Program', 'description': 'Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.\n\nROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.'}, {'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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.'}], 'classes': [{'title': 'Readiness at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.25', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '8.08', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': 'Readiness at Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.00', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '7.26', 'spread': '2.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4085', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Readiness at Follow Up', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2467', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Readiness from Baseline to Follow Up', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': 'One item measure to assess readiness to make changes to increase safety. This item was scored with a range from 0-10. 0=not prepared to change to 10=already changing. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to make changes to increase safety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ROSE Program', 'description': 'Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.\n\nROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.'}, {'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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "We recruited perinatal women from The Center for Women's Behavioral Health (WBH) at Women and Infants Hospital (WIH) between May 2015 and April 2016."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ROSE Program', 'description': 'Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program.\n\nROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.'}, {'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 ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 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': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', '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': '27.03', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '37'}, {'value': '28.32', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '36'}, {'value': '27.64', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '37'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2015-02-17', 'resultsFirstSubmitDate': '2017-11-01', 'studyFirstSubmitQcDate': '2015-02-17', 'lastUpdatePostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-05', 'studyFirstPostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Abuse Scale (CAS)-CAS Victimization Total Score', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': 'A widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.'}, {'measure': 'Safety Behavior Checklist (SBC)', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': 'Includes 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Items were scored as Yes=1 or No=0 or Not applicable. Scale range is from 0-15. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more use of safety behaviors.'}, {'measure': 'Effectiveness in Obtaining Resources Scale (EOR)', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': "Assesses the women's effectiveness in obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services. Items were scored as Yes=1 or No=0. Scale range is from 0-11. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more they were effective in obtaining resources."}], 'secondaryOutcomes': [{'measure': 'Motivation Scale', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': 'A 1-item measure, was modified to assess how ready they are to use treatment, resources, and/or support for any partner abuse. This item was scored with a range from 0-10. 0=not ready at all to 10=completely ready. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to use treatment, resources, or support for any partner abuse.'}, {'measure': 'The Readiness to Change Contemplation Ladder', 'timeFrame': 'Assessed at baseline, and again three months later', 'description': 'One item measure to assess readiness to make changes to increase safety. This item was scored with a range from 0-10. 0=not prepared to change to 10=already changing. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to make changes to increase safety.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intimate Partner Violence', 'Perinatal Women', 'Mental Health'], 'conditions': ['Intimate Partner Violence']}, 'referencesModule': {'references': [{'pmid': '32608505', 'type': 'DERIVED', 'citation': "Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2."}, {'pmid': '30088145', 'type': 'DERIVED', 'citation': 'Zlotnick C, Tzilos Wernette G, Raker CA. A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment. Arch Womens Ment Health. 2019 Jun;22(3):315-325. doi: 10.1007/s00737-018-0895-1. Epub 2018 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'The study developed and assessed an innovative, high-reach, easily implementable, low-cost computer-delivered intervention (Reach out for a Safe Environment; ROSE Program) that addressed known barriers in early identification and intervention with perinatal women with IPV seeking treatment for mental illness.', 'detailedDescription': 'Intimate partner violence (IPV) is a significant social and public health problem among perinatal women. Research suggests that from 21% to 33% of perinatal women report IPV and there is an enormous amount of morbidity associated with IPV. Moreover, IPV places a woman at high risk for several psychiatric disorders, which transforms the perinatal period from an already challenging process into a potentially overwhelming one. Further, IPV and untreated mental illness during the perinatal period pose a dual risk of adverse physical and emotional outcomes for women and their developing fetus/infant. Experts in the field advocate for more IPV screening and intervention to take place among women who are at high-risk for IPV. Given the high rates of IPV among women who seek mental health treatment, mental health clinics compared to other medical settings (e.g. primary care) are more effective sites for focused case finding and intervention. Further, the presence of IPV increases the likelihood of disengagement from treatment, which could compromise the ability of women with IPV to effectively use important shelter and community resources necessary for establishing safety for themselves and their children. A timely intervention might reduce the risk of future IPV, improve treatment utilization, and reduce mental health symptoms. A brief intervention that is designed specifically for the unique needs of perinatal women with IPV seeking mental health treatment provides a tremendous opportunity to intervene with a group of women who are particularly vulnerable and who might be unusually open to making changes to their lives.\n\nThis study is the first step towards developing a computer-based brief intervention ("Reach Out for a Safe Environment") that targets intimate partner violence in perinatal women in mental health treatment and constitutes the developmental aims of a larger study. The aims were to perform a small open trial (n = 8) of the Reach Out for a Safe Environment (ROSE) intervention to assess feasibility of recruitment of target population and acceptability of intervention and study procedures. Also, to conduct a randomized controlled pilot study in a sample of 50 perinatal women seeking mental health treatment who screen positive for recent IPV to demonstrate the acceptability and feasibility of the ROSE intervention via participant report of ease of use, helpfulness, and overall satisfaction.\n\nWe collected several measures on the feasibility of the research design, the acceptability of ROSE, and on intervention effects for IPV severity and level of self-care strategies (primary outcomes), motivation and self efficacy (secondary outcomes), and use of recommended mental health treatment services (tertiary outcome). This phase used a two-group, randomized, controlled design with an initial session for both conditions plus booster session one month later for the intervention condition. The initial intervention session was conducted close to an intake visit for mental health difficulties, with a booster session within one month following baseline. There was a 3-month follow up assessment. Assessments and the booster session were conducted in a private room or at a location that was a convenient location for the woman and one that provided a confidential, safe, and comfortable environment for the participant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant or postpartum women (up to 6 months after delivery)\n* Age 18 or older\n* Seeking mental health treatment at The Center for Women's Behavioral Health (WBH) at Women and Infants Hospital (WIH)\n* Endorsed any IPV during the past 12 months as measured by the Woman Abuse Screening Tool (WAST)\n\nExclusion Criteria:\n\n* Inability to provide informed consent (e.g., due to psychosis, intoxication, or other clear cognitive impairment)\n* Inability to understand English (understand the consent form when read aloud and assessments that are narrated by computer)"}, 'identificationModule': {'nctId': 'NCT02370394', 'briefTitle': 'Intervention for IPV Perinatal Women- RCT', 'organization': {'class': 'OTHER', 'fullName': 'Women and Infants Hospital of Rhode Island'}, 'officialTitle': 'Computer-Based Intervention for Victimized Perinatal Women With Mental Illness (Phase 1)', 'orgStudyIdInfo': {'id': '14-0056'}, 'secondaryIdInfos': [{'id': '1R21HD077358-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD077358-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ROSE Program', 'description': 'Participants received a 35-40-minute intervention on the Tablet PC and an in-person 10-15-minute booster session conducted by interventionists within a month after the intervention. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.', 'interventionNames': ['Behavioral: ROSE Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Condition', 'description': 'Control Condition consisted of a series of questions regarding television show preferences and then viewed a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later.'}], 'interventions': [{'name': 'ROSE Program', 'type': 'BEHAVIORAL', 'description': 'The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was tailored to the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.', 'armGroupLabels': ['ROSE Program']}]}, 'contactsLocationsModule': {'locations': [{'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}}], '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': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Behavioral Medicine Research', 'investigatorFullName': 'Caron Zlotnick', 'investigatorAffiliation': 'Women and Infants Hospital of Rhode Island'}}}}