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| Name | Class |
|---|---|
| University at Buffalo | OTHER |
| University of Louisville | OTHER |
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We will recruit sexual and gender minority couples to complete 56 days of daily surveys in order to evaluate (1) the impact of COVID-19 stress and sexual and gender minority stress on heavy episodic drinking and intimate partner violence (IPV) perpetration, and (2) a brief, mobile-phone delivered text messaging intervention to mitigate the effects of these stressors. This project has high potential to inform how pandemic stress contributes to etiological models of alcohol-related IPV perpetration in sexual and gender minority couples and inform a culturally-sensitive, low burden, and easy to disseminate intervention to mitigate these effects critical during a pandemic when access to care is limited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention, No Intervention (AA) | No Intervention | Participants do not receive text messages during Interval 2 or Interval 3. | |
| No Intervention, Attention-Control Texts (AB) | Active Comparator | Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
|
| No Intervention, CBT Texts (AC) | Experimental | Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3. |
|
| Attention-Control Texts, No Intervention (BA) | Active Comparator | Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3. |
|
| Attention-Control Texts, Attention-Control Texts (BB) | Active Comparator | Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT Text Messaging | Behavioral | Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction). |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use (Burst 1) | Proportion of reporting days on which alcohol was consumed | Burst 1, Daily for 14 days |
| Alcohol Use (Burst 2) | Proportion of reporting days on which alcohol was consumed | Burst 2, Daily for 14 days |
| Alcohol Use (Burst 3) | Proportion of reporting days on which alcohol was consumed | Burst 3, Daily for 14 days |
| Alcohol Use (Burst 4) | Proportion of reporting days on which alcohol was consumed | Burst 4, Daily for 14 days |
| Intimate Partner Violence (IPV) Perpetration (Burst 1) | Proportion of reporting days on which IPV perpetration occurred | Burst 1, Daily for 14 days |
| IPV Perpetration (Burst 2) | Proportion of reporting days on which IPV perpetration occurred | Burst 2, Daily for 14 days |
| IPV Perpetration (Burst 3) | Proportion of reporting days on which IPV perpetration occurred | Burst 3, Daily for 14 days |
| IPV Perpetration (Burst 4) | Proportion of reporting days on which IPV perpetration occurred |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Minority Stress (Burst 1) | Total daily count across 15 daily sexual minority stress (SMS) indicators | Burst 1, Daily for 14 days |
| Sexual Minority Stress (Burst 2) | Total daily count across 15 daily sexual minority stress (SMS) indicators |
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Inclusion Criteria (applies to both partners):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominic J Parrott, Ph.D. | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30302 | United States |
After the grant period, access to the data will be provided through the Inter-University Consortium for Political and Social Research (ICPSR). Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data source and funders. One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR. Data will be made publicly available through ICPSR's website.
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One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR.
Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data source and funders.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention, No Intervention (AA) | Participants do not receive text messages during Interval 2 or Interval 3. |
| FG001 | No Intervention, Attention-Control Texts (AB) | Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| FG002 | No Intervention, CBT Texts (AC) | Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3. |
| FG003 | Attention-Control Texts, No Intervention (BA) | Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3. |
| FG004 | Attention-Control Texts, Attention-Control Texts (BB) | Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| FG005 | Attention-Control Texts, CBT Texts (BC) | Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3. |
| FG006 | CBT Texts, No Intervention (CA) | Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3. |
| FG007 | CBT Texts, Attention-Control Texts (CB) | Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One participant (n=1) dropped from the analysis because the other dyad member was lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention, No Intervention (AA) | Participants do not receive text messages during Interval 2 or Interval 3. |
| BG001 | No Intervention, Attention-Control Texts (AB) | Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant's self-reported chronological age measured in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Use (Burst 1) | Proportion of reporting days on which alcohol was consumed | 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Proportion of reporting days | Burst 1, Daily for 14 days |
|
Adverse event data were collected from the time after participants completed the baseline survey until they time they completed the fourth burst of daily diaries (i.e., approximately 14 weeks).
This project's definition of an adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Intervention, No Intervention (AA) | Participants do not receive text messages during Interval 2 or Interval 3. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | The participant's death was not related to the intervention. The participant's partner reported the participant's death; however, we were not informed of the cause of death. Thus, we selected "General Disorders" as the organ system affected. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dominic Parrott, Distinguished University Professor of Psychology | Georgia State University | +1 (404) 413-6287 | parrott@gsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2025 | Apr 30, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2023 | Apr 30, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D013315 | Stress, Psychological |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
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Participants will be enrolled into a measurement burst daily diary design comprised of four 14-day bursts of daily surveys with three 14-day intervals that do not include daily surveys. There are three intervention conditions: (A) no intervention; (B) attention-control text messaging; or (C) CBT text messaging intervention. Between bursts 1 and 2 (Interval 1), all participants will be assigned to condition A (no intervention) such that all will complete the first two bursts (28 days) before receiving an intervention. Between bursts 2 and 3 (Interval 2) and bursts 3 and 4 (Interval 3), couples will be randomized to one of the following eight patterns of conditions: AA, AB, AC, BA, BB, BC, CA, or CB. There is no "CC" condition because the CBT intervention is not intended to be given in multiple two-week intervals.
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| Attention-Control Texts, CBT Texts (BC) | Experimental | Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3. |
|
| CBT Texts, No Intervention (CA) | Experimental | Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3. |
|
| CBT Texts, Attention-Control Texts (CB) | Experimental | Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
|
|
| Attention Control Text Messaging | Behavioral | Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions. |
|
| Burst 4, Daily for 14 days |
| Alcohol Use --> IPV Perpetration (Pre-Intervention) | Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2). | Bursts 1 and 2 (daily for 14 x 2 days) |
| Alcohol Use --> IPV Perpetration (Post-Intervention) | Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2). | Bursts 3 and 4 (daily for 14 x 2 days) |
| Burst 2, Daily for 14 days |
| Sexual Minority Stress (Burst 3) | Total daily count across 15 daily sexual minority stress (SMS) indicators | Burst 3, Daily for 14 days |
| Sexual Minority Stress (Burst 4) | Total daily count across 15 daily sexual minority stress (SMS) indicators | Burst 4, Daily for 14 days |
| Gender Minority Stress (Burst 1) | Total daily count across 14 daily gender minority stress (GMS) indicators | Burst 1, Daily for 14 days |
| Gender Minority Stress (Burst 2) | Total daily count across 14 daily gender minority stress (GMS) indicators | Burst 2, Daily for 14 days |
| Gender Minority Stress (Burst 3) | Total daily count across 14 daily gender minority stress (GMS) indicators | Burst 3, Daily for 14 days |
| Gender Minority Stress (Burst 4) | Total daily count across 14 daily gender minority stress (GMS) indicators | Burst 4, Daily for 14 days |
| COVID Stress (Burst 1) | Average daily count of COVID stress (CS) indicators | Burst 1, Daily for 14 days |
| COVID Stress (Burst 2) | Average daily count of COVID stress (CS) indicators | Burst 2, Daily for 14 days |
| COVID Stress (Burst 3) | Average daily count of COVID stress (CS) indicators | Burst 3, Daily for 14 days |
| COVID Stress (Burst 4) | Average daily count of COVID stress (CS) indicators | Burst 4, Daily for 14 days |
| Death |
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| Withdrawal by Subject |
|
| BG002 | No Intervention, CBT Texts (AC) | Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3. |
| BG003 | Attention-Control Texts, No Intervention (BA) | Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3. |
| BG004 | Attention-Control Texts, Attention-Control Texts (BB) | Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| BG005 | Attention-Control Texts, CBT Texts (BC) | Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3. |
| BG006 | CBT Texts, No Intervention (CA) | Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3. |
| BG007 | CBT Texts, Attention-Control Texts (CB) | Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| BG008 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Prompt: What sex were you assigned at birth? | Count of Participants | Participants |
|
| Race (NIH/OMB) | Prompt: How do you describe your race (Select all that apply)? | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Prompt: How do you describe your ethnicity? | Count of Participants | Participants |
|
| Gender minority status | Indicator of correspondence between self-reported sex assigned at birth and answer to the following prompt: How do you describe your gender (select all that apply)? | Count of Participants | Participants |
|
| No Intervention, Attention-Control Texts (AB) |
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| OG002 | No Intervention, CBT Texts (AC) | Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3. |
| OG003 | Attention-Control Texts, No Intervention (BA) | Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3. |
| OG004 | Attention-Control Texts, Attention-Control Texts (BB) | Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
| OG005 | Attention-Control Texts, CBT Texts (BC) | Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3. |
| OG006 | CBT Texts, No Intervention (CA) | Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3. |
| OG007 | CBT Texts, Attention-Control Texts (CB) | Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3. |
|
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| Primary | Alcohol Use (Burst 2) | Proportion of reporting days on which alcohol was consumed | Only 448 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Proportion of reporting days | Burst 2, Daily for 14 days |
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| Primary | Alcohol Use (Burst 3) | Proportion of reporting days on which alcohol was consumed | Only 429 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Proportion of reporting days | Burst 3, Daily for 14 days |
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| Primary | Alcohol Use (Burst 4) | Proportion of reporting days on which alcohol was consumed | Only 435 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Proportion of reporting days | Burst 4, Daily for 14 days |
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| Primary | Intimate Partner Violence (IPV) Perpetration (Burst 1) | Proportion of reporting days on which IPV perpetration occurred | 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Proportion of reporting days | Burst 1, Daily for 14 days |
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| Primary | IPV Perpetration (Burst 2) | Proportion of reporting days on which IPV perpetration occurred | Only 448 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Proportion of reporting days | Burst 2, Daily for 14 days |
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| Primary | IPV Perpetration (Burst 3) | Proportion of reporting days on which IPV perpetration occurred | Only 429 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Proportion of reporting days | Burst 3, Daily for 14 days |
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| Primary | IPV Perpetration (Burst 4) | Proportion of reporting days on which IPV perpetration occurred | Only 435 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Proportion of reporting days | Burst 4, Daily for 14 days |
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| Secondary | Sexual Minority Stress (Burst 1) | Total daily count across 15 daily sexual minority stress (SMS) indicators | Only 451 of 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of SMS indicators | Burst 1, Daily for 14 days |
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| Secondary | Sexual Minority Stress (Burst 2) | Total daily count across 15 daily sexual minority stress (SMS) indicators | Only 447 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of SMS indicators | Burst 2, Daily for 14 days |
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| Secondary | Sexual Minority Stress (Burst 3) | Total daily count across 15 daily sexual minority stress (SMS) indicators | Only 428 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of SMS indicators | Burst 3, Daily for 14 days |
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| Secondary | Sexual Minority Stress (Burst 4) | Total daily count across 15 daily sexual minority stress (SMS) indicators | Only 434 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of SMS indicators | Burst 4, Daily for 14 days |
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| Secondary | Gender Minority Stress (Burst 1) | Total daily count across 14 daily gender minority stress (GMS) indicators | Only 162 of 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of GMS indicators | Burst 1, Daily for 14 days |
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| Secondary | Gender Minority Stress (Burst 2) | Total daily count across 14 daily gender minority stress (GMS) indicators | Only 162 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of GMS indicators | Burst 2, Daily for 14 days |
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| Secondary | Gender Minority Stress (Burst 3) | Total daily count across 14 daily gender minority stress (GMS) indicators | Only 145 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of GMS indicators | Burst 3, Daily for 14 days |
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| Secondary | Gender Minority Stress (Burst 4) | Total daily count across 14 daily gender minority stress (GMS) indicators | Only 153 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of GMS indicators | Burst 4, Daily for 14 days |
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| Secondary | COVID Stress (Burst 1) | Average daily count of COVID stress (CS) indicators | 452 participants, across all arms, had reported outcome for Burst 1. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of CS indicators | Burst 1, Daily for 14 days |
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| Secondary | COVID Stress (Burst 2) | Average daily count of COVID stress (CS) indicators | Only 447 of 452 participants, across all arms, had reported outcome for Burst 2. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of CS indicators | Burst 2, Daily for 14 days |
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| Secondary | COVID Stress (Burst 3) | Average daily count of COVID stress (CS) indicators | Only 427 of 452 participants, across all arms, had reported outcome for Burst 3. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of CS indicators | Burst 3, Daily for 14 days |
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| Secondary | COVID Stress (Burst 4) | Average daily count of COVID stress (CS) indicators | Only 432 of 452 participants, across all arms, had reported outcome for Burst 4. Results data were pre-specified according to the Study Protocol and Statistical Analysis Plan to be assessed in the per-sequence Arms/Groups (e.g., "No Intervention, No Intervention (AA)", "Attention-Control Texts, Attention-Control Texts (BB)", "CBT Texts, Attention-Control Texts (CB)"). Thus, no arms are combined and all results are reported for each arm separately. | Posted | Mean | Standard Deviation | Average daily count of CS indicators | Burst 4, Daily for 14 days |
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| Primary | Alcohol Use --> IPV Perpetration (Pre-Intervention) | Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2). | The Study Aims, as funded, sought to compare combinations of intervention arms. Thus, per this proposed analytic strategy, arms corresponding to control or intervention status were combined as appropriate to permit the analysis of hypothesized intervention main effects. | Posted | Number | 95% Confidence Interval | Odds Ratio | Bursts 1 and 2 (daily for 14 x 2 days) |
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| Primary | Alcohol Use --> IPV Perpetration (Post-Intervention) | Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2). | The Study Aims, as funded, sought to compare combinations of intervention arms. Thus, per this proposed analytic strategy, arms corresponding to control or intervention status were combined as appropriate to permit the analysis of hypothesized intervention main effects. | Posted | Number | 95% Confidence Interval | Odds Ratio | Bursts 3 and 4 (daily for 14 x 2 days) |
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|
| 1 |
| 40 |
| 1 |
| 40 |
| 0 |
| 40 |
| EG001 | No Intervention, Attention-Control Texts (AB) | Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3. Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions. | 0 | 38 | 0 | 38 | 0 | 38 |
| EG002 | No Intervention, CBT Texts (AC) | Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3. CBT Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction). | 0 | 76 | 0 | 76 | 0 | 76 |
| EG003 | Attention-Control Texts, No Intervention (BA) | Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3. Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG004 | Attention-Control Texts, Attention-Control Texts (BB) | Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3. Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG005 | Attention-Control Texts, CBT Texts (BC) | Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3. CBT Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction). Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions. | 0 | 80 | 0 | 80 | 0 | 80 |
| EG006 | CBT Texts, No Intervention (CA) | Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3. CBT Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction). | 0 | 80 | 0 | 80 | 0 | 80 |
| EG007 | CBT Texts, Attention-Control Texts (CB) | Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3. CBT Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction). Attention Control Text Messaging: Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions. | 0 | 80 | 0 | 80 | 0 | 80 |
|
Not provided
Not provided
| D012919 |
| Social Behavior |