Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2026-01-11 @ 5:10 PM
Study NCT ID:
NCT04691492
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2020-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Protecting Allies in Risky Situations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067292', 'term': 'Alcohol Drinking in College'}], 'ancestors': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jpread@buffalo.edu', 'phone': '(716) 645-0193', 'title': 'Jennifer Read, PhD.', 'organization': 'University at Buffalo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'No assessment after the conclusion of data collection. So at baseline, biweekly for 12 weeks for treatment and monthly for 3 months for waitlist.', 'eventGroups': [{'id': 'EG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping.", 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Readiness to Intervene on the Readiness Ruler', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.22', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '1.97', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '8.60', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '8.52', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '9.15', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '1.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': "Participants will use an 11-point likert-type scale modeled after the Readiness Ruler to rate their readiness for intervening. Responses range from 0 (I never think about my and/or my friend's risk of being sexually assaulted) to 10 (I am actively and consistently taking steps to protect myself and/or my friends from sexual assault), with higher scores indicating a greater readiness to intervene.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Readiness to Intervene on the Decisional Balance Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.92', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '4.86', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 month follow up', 'description': 'The 10-item Decisional Balance Scale (Banyard et al., 2007) is used to assess ambivalence about intervening in a potential assault situation. Responses regarding the decision whether to intervene or not are rated on a 5-point Likert scale ranging from 1 (Not at all likely) to 5 (Extremely likely), with higher scores indicating a greater readiness to intervene.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.81', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.66', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.73', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '2.54', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': "This 8-item survey measures awareness of and strategies for alcohol's effects on helping behavior and participants' understanding of the ways that alcohol may interfere with helping behavior. Responses range from 1 (Not at all true) to 5 (Very much true), with higher scores indicating a greater understanding of how alcohol interferes with helping behavior.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.98', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.19', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.45', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'The Friend-based Assault Protective Strategies Assessment uses 20 items to assess sexual assault preventive strategy use. Responses range from 1 (Not at all) to 4 (A lot), with higher scores indicating a greater use of strategies to prevent sexual assault.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'We used a modified version of The Bystander Behaviors Scale for Friends is a 44-item measure which includes 4 sub-scales (1) the identification of sexual assault risk situations, (2) accessing resources, (3) planning ahead for risk situations, and (4) safety behaviors in risk settings. We used a selection of 20 questions from the full measure including items from each subscale. Response option include (0) No I did not engage in this behavior, (1) Yes I did engage in this behavior, or (missing) I did not perceive an opportunity to engage in this behavior. A higher endorsement of "Yes" (higher score) engaging in the behaviors is considered to indicate a greater use of strategies to prevent sexual assault.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.43', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.57', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.47', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.39', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '2.47', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'The Barriers to Sexual Assault Bystander Intervention Scale is a 16-item measure to assess barriers to intervening. Responses range from 1 (Strongly disagree) to 7 (Strongly agree), with higher scores indicating greater perceived barriers to intervening.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.01', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'The Concerns About Intervening Scale uses 6 items to assess perceived barriers to intervening, focused on worries. Responses range from 1 (Not at all true) to 6 (Very much true), with higher scores indicating greater perceived barriers to intervening.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sexual Assault', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Month 1', 'categories': [{'title': 'No', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'title': 'No', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'title': 'No', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Prefer not to answer', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Monthly after baseline for 3 months', 'description': 'Revised Sexual Experiences Survey (R-SES) will be used to assess each social occasion with the target friend in the prior 2 weeks. Each item will be coded 1 (yes) or 0 (no), based on whether it happened to the woman/friend on each occasion that the pair socialized together.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Drinking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'OG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.84', 'spread': '5.34', 'groupId': 'OG000'}, {'value': '10.79', 'spread': '7.93', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '7.06', 'spread': '4.96', 'groupId': 'OG000'}, {'value': '8.92', 'spread': '4.77', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '6.13', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '6.14', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '6.27', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '6.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'Using a grid-based average assessment measure based in the Daily Drinking Questionnaire, participants will report on alcohol consumption. Higher scores indicate greater alcohol consumption.', 'unitOfMeasure': 'Amount of drinks consumed weekly', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'FG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants (N=108, 54 dyads) were recruited using a multi-method, community-based recruitment plan, including: digital and print advertisements, social media, email blasts to psychology and nursing student listservs, flyers posted in locations frequented by emerging adults (e.g., college campuses, coffee shops, bars) and word of mouth. A QR code and/or link directed interested individuals to a secure platform to learn more about the trial and complete a brief initial eligibility questionnaire.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Friends-Based Motivational Interview (FMI) Group', 'description': "Will participate in the Friends-Based Motivational Interview (FMI) program.\n\nFriend-Based Motivational Interview: The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping."}, {'id': 'BG001', 'title': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '102', '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': '19.62', 'spread': '1.01', 'groupId': 'BG000'}, {'value': '19.48', 'spread': '1.06', 'groupId': 'BG001'}, {'value': '19.6', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Male', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Year in College', 'classes': [{'categories': [{'title': 'Freshman', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Sophomore', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Junior', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Senior', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Housing', 'classes': [{'categories': [{'title': 'Residence Hall', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'On campus', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Home (with family)', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'House or apartment (off campus, not with family)', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'GPA', 'classes': [{'categories': [{'measurements': [{'value': '3.30', 'spread': '0.47', 'groupId': 'BG000'}, {'value': '3.28', 'spread': '0.51', 'groupId': 'BG001'}, {'value': '3.29', 'spread': '0.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Grade Point Average (GPA) is 4 point scale used by most colleges to average the grades of students. The range is 0.0-4.0 with a 4.0 representing higher grades on average. The score is obtained by converting each letter grade a student received into a number (A=4, A-=3.67, B+=3.33, B=3...) then finding the mean of those numbers.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Greek Affiliation', 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employed', 'classes': [{'categories': [{'title': "No, I'm not working", 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Yes, part time (irregular hours)', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Yes, part-time (approximately 20 hours)', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Yes, full-time (approximately 40 hours)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '6 participants dropped out before completing the baseline which is why the total here is 102 where the total enrollment was 108.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-20', 'size': 1194073, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-30T10:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2020-12-11', 'resultsFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-23', 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Readiness to Intervene on the Readiness Ruler', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': "Participants will use an 11-point likert-type scale modeled after the Readiness Ruler to rate their readiness for intervening. Responses range from 0 (I never think about my and/or my friend's risk of being sexually assaulted) to 10 (I am actively and consistently taking steps to protect myself and/or my friends from sexual assault), with higher scores indicating a greater readiness to intervene."}, {'measure': 'Change in Readiness to Intervene on the Decisional Balance Scale', 'timeFrame': 'Baseline and 3 month follow up', 'description': 'The 10-item Decisional Balance Scale (Banyard et al., 2007) is used to assess ambivalence about intervening in a potential assault situation. Responses regarding the decision whether to intervene or not are rated on a 5-point Likert scale ranging from 1 (Not at all likely) to 5 (Extremely likely), with higher scores indicating a greater readiness to intervene.'}, {'measure': 'Change in Awareness and Strategies Regarding Alcohol Effects on Helping Survey', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': "This 8-item survey measures awareness of and strategies for alcohol's effects on helping behavior and participants' understanding of the ways that alcohol may interfere with helping behavior. Responses range from 1 (Not at all true) to 5 (Very much true), with higher scores indicating a greater understanding of how alcohol interferes with helping behavior."}, {'measure': 'Change in Friend-Based Helping Skills on Friend-based Assault Protective Strategies Assessment', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'The Friend-based Assault Protective Strategies Assessment uses 20 items to assess sexual assault preventive strategy use. Responses range from 1 (Not at all) to 4 (A lot), with higher scores indicating a greater use of strategies to prevent sexual assault.'}, {'measure': 'Change in Friend-Based Helping Skills on the Bystander Behaviors Scale for Friends', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'We used a modified version of The Bystander Behaviors Scale for Friends is a 44-item measure which includes 4 sub-scales (1) the identification of sexual assault risk situations, (2) accessing resources, (3) planning ahead for risk situations, and (4) safety behaviors in risk settings. We used a selection of 20 questions from the full measure including items from each subscale. Response option include (0) No I did not engage in this behavior, (1) Yes I did engage in this behavior, or (missing) I did not perceive an opportunity to engage in this behavior. A higher endorsement of "Yes" (higher score) engaging in the behaviors is considered to indicate a greater use of strategies to prevent sexual assault.'}, {'measure': 'Change in Perceived Barriers to Intervening on the Barriers to Sexual Assault Bystander Intervention Scale', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'The Barriers to Sexual Assault Bystander Intervention Scale is a 16-item measure to assess barriers to intervening. Responses range from 1 (Strongly disagree) to 7 (Strongly agree), with higher scores indicating greater perceived barriers to intervening.'}, {'measure': 'Change in Perceived Barriers to Intervening on the Concerns About Intervening Scale', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'The Concerns About Intervening Scale uses 6 items to assess perceived barriers to intervening, focused on worries. Responses range from 1 (Not at all true) to 6 (Very much true), with higher scores indicating greater perceived barriers to intervening.'}], 'secondaryOutcomes': [{'measure': 'Sexual Assault', 'timeFrame': 'Monthly after baseline for 3 months', 'description': 'Revised Sexual Experiences Survey (R-SES) will be used to assess each social occasion with the target friend in the prior 2 weeks. Each item will be coded 1 (yes) or 0 (no), based on whether it happened to the woman/friend on each occasion that the pair socialized together.'}, {'measure': 'Change in Drinking', 'timeFrame': 'Baseline and Monthly for 3 months', 'description': 'Using a grid-based average assessment measure based in the Daily Drinking Questionnaire, participants will report on alcohol consumption. Higher scores indicate greater alcohol consumption.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexual Assault', 'College Drinking', 'Behavioral Changes']}, 'referencesModule': {'references': [{'pmid': '39715424', 'type': 'DERIVED', 'citation': 'Read JP, Livingston JA, Shaw RJ, Wiseblatt AF, Jenzer T, DiPaolo LR, Mastroleo NR, Katz J, Testa M, Colder CR. The power of friends in reducing sexual assault risk in college women: A preliminary test of dyad-based motivational intervention approach. J Consult Clin Psychol. 2024 Dec;92(12):814-827. doi: 10.1037/ccp0000925.'}]}, 'descriptionModule': {'briefSummary': 'The current project will provide testing of a friend-based motivational interview (FMI) designed to reduce sexual assault risk. The study will address if the intervention minimizes the impact of alcohol on helping behavior, test whether drinking reduces intervention efficacy, and examine potential iatrogenic effects of the intervention.', 'detailedDescription': "The objective of the proposed study is to develop an innovative, friend-based motivational interview (FMI) that encourages and prepares friends to reduce sexual assault (SA) risk. Delivered to pairs of friends (dyads), the FMI will be designed to foster collaborative efforts to increase readiness for, and decrease barriers to helping behavior, and to teach and plan together for assault prevention skills. As the role of alcohol has been under-addressed in SA prevention efforts, the FMI also will explicitly attend to how intoxication may serve as a barrier to friend intervention, and strategies for overcoming this barrier. The completion of this project's aims will yield a novel intervention that capitalizes on the natural resource of women's friendships to decrease risk for sexual assault - a pervasive public health problem affecting a substantial portion of young adult women in the U.S.\n\nTwenty-four friend dyads will participate in the friend-based motivational interview (FMI) along with 24 wait-list control dyads (total of 48 dyads). The study will compare groups on outcomes at post-intervention and at bi-weekly 3 month follow-ups, and also examine within participant change. The study will focus on whether effects are in the expected direction and whether the strength of effect sizes are of practical magnitude. It is expected that participants receiving the FMI will demonstrate significant increases in readiness, and engagement in friend assault prevention behavioral skills (FAPBs), and demonstrate decreases in perceived barriers, at post-intervention and over the 3-month follow-up. Follow-up data will be utilized to provide a rich description of the role of alcohol in implementing FAPBs, and whether the FMI reduces the impact of alcohol use. In exploratory analyses, it will be examined whether the intervention may be associated with decreased assault risk, as well as decreased drinking."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female dyads who go out together at least once a week\n* Undergraduates enrolled in a 4-year college or university\n* Meet heavy episodic drinking (HED) criteria, 4 or more drinks in a single sitting, 2 or more times monthly\n\nExclusion Criteria:\n\nNot Applicable'}, 'identificationModule': {'nctId': 'NCT04691492', 'acronym': 'PAIRS', 'briefTitle': 'Protecting Allies in Risky Situations', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Harnessing the Power of Friends to Reduce Alcohol-Involved Sexual Assault Risk', 'orgStudyIdInfo': {'id': 'R34AA027046', 'link': 'https://reporter.nih.gov/quickSearch/R34AA027046', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R34AA027046', 'link': 'https://reporter.nih.gov/quickSearch/R34AA027046', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Friends-Based Motivational Interview (FMI) Group', 'description': 'Will participate in the Friends-Based Motivational Interview (FMI) program.', 'interventionNames': ['Behavioral: Friend-Based Motivational Interview']}, {'type': 'NO_INTERVENTION', 'label': 'Wait List Control', 'description': 'The Wait List Control group will also be offered to participate in the Friends-Based Motivational Interview Program but at a deferred date (12 weeks later).'}], 'interventions': [{'name': 'Friend-Based Motivational Interview', 'type': 'BEHAVIORAL', 'description': "The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping.", 'armGroupLabels': ['Friends-Based Motivational Interview (FMI) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14260', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo Department of Psychology', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Jennifer P Read, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available in December 2021 and will be available until 2026.', 'ipdSharing': 'YES', 'description': "The investigators will share a de-identified data set which will include baseline demographics and readiness to intervene, awareness of alcohol's effects on helping behaviors, friend-based assault protective strategy use, and perception of barriers to intervening outcomes.", 'accessCriteria': 'There must be an articulation of a clear research question and analytic plan by an established investigator with the relevant credentials. The information will be shared as a digital file through email.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jennifer Read', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}