Trial Outcomes & Findings for Evaluation of PRYSHM for LGBTQIA2S+ Youth (NCT NCT05521906)
NCT ID: NCT05521906
Last Updated: 2025-04-18
Results Overview
The Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Perpetration Scale assesses how often an individual perpetrates dating violence. Participants rate how frequently they engaged in specific behaviors from 0 to 100 times over the past three months (at Week 21). The total score was created by summing the items. The range is 0 to 476. Higher scores represent more intimate partner violence perpetration.
COMPLETED
NA
314 participants
Week 21
2025-04-18
Participant Flow
Participant milestones
| Measure |
Intervention
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
Check-ins/provision of resources
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
101
|
|
Overall Study
COMPLETED
|
204
|
100
|
|
Overall Study
NOT COMPLETED
|
9
|
1
|
Reasons for withdrawal
| Measure |
Intervention
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
Check-ins/provision of resources
|
|---|---|---|
|
Overall Study
removed by researchers for offensive or deceptive behavior
|
9
|
1
|
Baseline Characteristics
Evaluation of PRYSHM for LGBTQIA2S+ Youth
Baseline characteristics by cohort
| Measure |
Intervention
n=204 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=100 Participants
Check-ins/provision of resources
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
204 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16.53 years
STANDARD_DEVIATION 0.88 • n=5 Participants
|
16.53 years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
16.53 years
STANDARD_DEVIATION 0.89 • n=5 Participants
|
|
Sex/Gender, Customized
Boy/Man
|
32 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Girl/Woman
|
66 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Genderqueer
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
33 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unsure/questioning
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans girl/woman
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Trans boy/man
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Refused
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
152 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
59 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
204 participants
n=5 Participants
|
100 participants
n=7 Participants
|
304 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Perpetration Scale assesses how often an individual perpetrates dating violence. Participants rate how frequently they engaged in specific behaviors from 0 to 100 times over the past three months (at Week 21). The total score was created by summing the items. The range is 0 to 476. Higher scores represent more intimate partner violence perpetration.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Intimate Partner Violence Perpetration at Week 21
|
5.79 score on a scale
Standard Deviation 39.85
|
4.46 score on a scale
Standard Deviation 11.02
|
PRIMARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Victimization Scale assesses how often an individual experiences abusive behavior from a romantic partner. Participants indicate how often they have been the victim of abuse from 0 to 100 times in the past three months (at Baseline, Week 21). The total score was created by summing the items. The range is 0 to 105. Higher scores represent more intimate partner violence victimization.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Intimate Partner Violence Victimization at Week 21
|
5.57 units on a scale
Standard Deviation 16.56
|
6.83 units on a scale
Standard Deviation 19.73
|
PRIMARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Alcohol Use Questionnaire is based on the Daily Drinking Questionnaire and assesses an individual's alcohol use. Participants indicate how often they have used/abused alcohol within their lifetime, over the past 3 months on a scale of "0" to "40+". recoded the response scale using the mid-point of each response option (recoded values: 0 = 0, 1 = 1, 2 = 2, 3 = 3, 4 = 4, 5 = 5, 6 = 7.5, 7 = 14.5, 8 = 29.5, 9 = 40. Mean scores were then calculated. The range is 0 to 9. Higher scores represent more alcohol use.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Alcohol Use at Week 21
|
1.13 score on a scale
Standard Deviation 2.58
|
1.86 score on a scale
Standard Deviation 4.37
|
PRIMARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Conflict Tactics Scale-Revised: Sexual and Gender Minority Specific Intimate Partner Violence Perpetration (CTS-2:IPV-Perpetration, SGM specific) assesses how often an individual identifying as a sexual and/or gender minority perpetrates dating violence. Participants rate how frequently they engaged in specific behaviors from 0 to 100 times over the past three months (Week 21). The total score was created by summing the items. The range is 0 to 5. Higher scores represent more sexual and gender minority specific intimate partner violence perpetration.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Sexual and Gender Minority Specific Intimate Partner Violence Perpetration at Week 21
|
0.04 units on a scale
Standard Deviation 0.42
|
0.10 units on a scale
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Conflict Tactics Scale-Revised: Sexual and Gender Minority Specific Intimate Partner Violence Victimization (CTS-2:IPV-Victimization, SGM specific) assesses how often an individual identifying as a sexual and/or gender minority victimizes dating violence. Participants rate how frequently they engaged in specific behaviors from 0 to 100 times over the past three months (Week 21). The total score was created by summing the items. The range is 0 to 16. Higher scores represent more sexual and gender minority specific intimate partner violence victimization.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Sexual and Gender Minority Specific Intimate Partner Violence Victimization at Week 21
|
0.35 units on a scale
Standard Deviation 1.75
|
0.53 units on a scale
Standard Deviation 1.91
|
PRIMARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Drinking Intentions Questionnaire is an instrument based on the Daily Drinking Questionnaire and assesses how likely an individual is to drink in the future. Participants to rate how likely they are to drink alcohol in the next three months (Week 21) on a scale of 0 to 4 ("definitely will" to "definitely won't") on one item. The range is 0 to 4. Higher scores represent more drinking intentions.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Drinking Intentions at Week 21
|
1.50 score on a scale
Standard Deviation 1.35
|
1.32 score on a scale
Standard Deviation 1.33
|
PRIMARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Willingness to Drink Questionnaire assesses intensity of drinking behavior. Participants rate how likely they would be to drink at varying levels of intensity on a scale from 0 to 3 ("not at all" to "very willing") given a specific scenario. The mean score was created. The range is 0 to 3. Higher scores represent more willingness to drink
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Willingness to Drink at Week 21
|
1.20 score on a scale
Standard Deviation 1.00
|
1.04 score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Brief Young Adult Alcohol Consequences Questionnaire is a validated, self-report instrument assessing the frequency with which an individual has experienced negative consequences as a result of drinking alcohol. Participants are asked to indicate if they have experienced a specific consequence of drinking alcohol in the past three months (Week 21) with a "yes" or "no" answer. The number of "yes" responses provides an indication of the severity of alcohol-related consequences. The total score was created by summing the items. The range is 0 to 24. Higher scores represent higher levels of problems and consequences from alcohol use.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Experience of Negative Consequences as a Result of Alcohol Use at Week 21
|
1.01 score on a scale
Standard Deviation 2.71
|
1.26 score on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The construct will be measured using 8 items from the Patient Health Questionnaire-9 Item (PHQ-9) which is a validated, self-report instrument assessing experience of symptoms associated with major depressive disorder. Participants are asked to measure how many days in the past two weeks they have experienced a symptom of depression on a scale of 0 (not at all) to 3 (nearly every day). The sum of all responses is used to indicate likelihood of major depressive disorder. Higher scores indicate higher depressive symptomology.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Depressive Symptoms at Week 21
|
9.07 score on a scale
Standard Deviation 6.35
|
10.00 score on a scale
Standard Deviation 5.90
|
SECONDARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The construct will be measured using two questions from the Youth Risk Behavior Surveillance (YRBS) questionnaire that address drug use. Participants are asked to indicate if they have used specific drugs in the past three months (Week 21) with either 1) yes or 0) no. The range is 0 to 1. A score of 1 indicates the use of drugs and therefore is considered a worse outcome.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Drug Use at Week 21
|
0.38 score on a scale
Standard Deviation 0.49
|
0.44 score on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Sexual Risk Survey is a validated self-report measure assess how often an individual has engaged in risky sexual behavior. Participants indicate how often they have engaged in risky sexual behaviors in the past three months (week 21) on a scale of "0" to "30+". A composite score was created by recoding each item (0, 1, and 2 or more) and then creating a sum. The range is 0 to 8. Higher scores indicate higher levels of sexual risk.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Sexual Risk-Taking as Measured by the Sexual Risk Survey at Week 21
|
2.13 score on a scale
Standard Deviation 2.17
|
1.82 score on a scale
Standard Deviation 2.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Outness Inventory for Sexual Orientation Family Subscale is a modified measures that determine to what extent an individual's family members knows about the sexual orientation of the individual. Scores are analyzed as a sum of individuals and groups who are aware of the individual's sexual orientation. The range is 0 to 1. Higher scores indicate higher levels of outness.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Identity Concealment Behaviors as Measured by the Outness Inventory for Sexual Orientation Family Subscale at Week 21
|
0.89 score on a scale
Standard Deviation 0.29
|
0.92 score on a scale
Standard Deviation 0.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Adapted Homonegativity Items constitute a validated self-report measure that assesses to what extent an individual experiences internalized homonegativity. Individuals are asked to indicate their agreement with specific statements representing internalized homonegativity on a scale from 1 (strongly disagree) to 4 (strongly agree). Responses are averaged to provide an indication of internalized homonegativity. The range is 1 to 4. Higher scores indicate higher levels of internalized stigma.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Experiences of Internalized Homonegativity at Week 21
|
1.83 score on a scale
Standard Deviation 0.61
|
1.97 score on a scale
Standard Deviation 0.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Psychological Sense of LGBT Community is a validated, self-report measure that assesses the extent to which an individual feels they belong to and contribute to the LGBTQIA2S+ community. Participants rate how often they feel specific indicators of LGBTQIA25+ community on a scale from 1 (none) to 5 (a great deal). The measure provides two subscales: needs fulfillment and membership. Responses within each subscale and overall scale are calculated to provide a mean score. Higher scores indicate higher levels of sense of community.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Sense of LGBTQIA2S+ Community at Week 21
Membership Subscale
|
3.25 score on a scale
Standard Deviation 0.90
|
2.96 score on a scale
Standard Deviation 1.14
|
|
Sense of LGBTQIA2S+ Community at Week 21
Needs Fulfilment
|
2.80 score on a scale
Standard Deviation 0.89
|
2.59 score on a scale
Standard Deviation 0.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Difficulties in Emotion Regulation Scale (DERS-16): Impulse Control Subscale assesses an individual's capacity for impulse control. Participants rate how often they feel out of control of their emotions when upset on a scale of 1 (almost never) to 5 (almost always). Responses are summed with higher scores reflecting greater levels of emotional dysregulation. The range is 3 to 15.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Emotional Regulation and Coping at Week 21
|
6.77 score on a scale
Standard Deviation 2.91
|
6.40 score on a scale
Standard Deviation 2.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Communication Skills Test: 10-Item Version (CST-10) is a validated, self-report measure which assesses how likely an individual is to utilize specific conflict resolution skills when experiencing conflict with a romantic partner. Participants are asked to rate how easy or difficult it would be to engage in specified de-escalation strategies on a scale of 1 (very difficult) to 4 (very easy). The scale is computed by creating a mean score from the item responses, including reverse-scored items. The range is 1 to 4. Higher scores indicate higher levels of conflict resolution skill self-efficacy.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Conflict Resolution Skills as Measured by the Communication Skills Test at Week 21
|
3.21 score on a scale
Standard Deviation 0.51
|
3.20 score on a scale
Standard Deviation 0.49
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Sexual Communication Self-Efficacy Scale assesses capacity for refusal during intimate interactions. Participants rate how difficult it would be to refuse a sexual request on a scale of 1 (very difficult) to 4 (very easy). The measure provides two subscales: negative sexual messages, positive sexual messages. The respective subscale scores are calculated by taking the means of the subscale's items. The range is 1 to 4. Higher scores indicate higher levels of sexual communication self-efficacy.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Sexual Refusal Skills at Week 21
Negative messages
|
3.14 score on a scale
Standard Deviation 0.72
|
3.16 score on a scale
Standard Deviation 0.73
|
|
Sexual Refusal Skills at Week 21
Positive Messages
|
3.13 score on a scale
Standard Deviation 0.71
|
3.22 score on a scale
Standard Deviation 0.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
Bringing in the Bystander Intervention Items assesses the capacity to intervene in instances of dating violence. Participants rate how likely they would be to intervene in a specific situation from 1 to 4 ("very unlikely" to "very likely"). The measure provides two subscales: reactive and proactive. Subscale scores are calculated by summing item responses and then dividing by the number of items to produce a mean subscale score. The summed ranges are 6 to 24 for reactive subscale with 6 items. The summed ranges are 3 to 12 for proactive subscale with 3 items. Higher scores indicate higher levels of bystander behavior intentions on each of the two subscales.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Bystander Behavior at Week 21
Reactive
|
3.58 score on a scale
Standard Deviation 0.43
|
3.51 score on a scale
Standard Deviation 0.52
|
|
Bystander Behavior at Week 21
Proactive
|
3.49 score on a scale
Standard Deviation 0.59
|
3.46 score on a scale
Standard Deviation 0.67
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Perceived Dating Violence Norms, adapted from the Measure of Adolescent Relationship Harassment and Abuse (MARSHA)-Perpetration scale, assesses an perceptions of dating violence within LGBTQIA2S+ teenage relationships. Participants indicate what percentage of LGBTQIA2S+ teenage relationships they believe experience specific scenarios related to abuse. The measure provides 6 subscales: social control, physical abuse, sexual abuse, isolation, cyber control, intimidation. Subscale scores are calculated by averaging item responses on the respective subscale. The range is 0 to 73.81. Higher scores represent more perceived dating violence norms.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Accurate Perceptions of Dating Violence at Week 21
|
13.36 score on a scale
Standard Deviation 15.03
|
16.39 score on a scale
Standard Deviation 15.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Alcohol Reduction Strategies- Current Confidence Questionnaire (ARS-CC) is a validated, self-report measure which assesses an individual's use of alcohol reduction strategies to prevent negative consequences associated with alcohol use. Participants are asked to rate how confident they are in their ability to utilize a given strategy on a 5 point scale of 1 (not at all confident) to 5 (completely confident). Responses are averaged to provide an overall mean score, with a higher indicating a greater capacity to utilize alcohol reduction strategies.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Protective Behavioral Strategies as Measured by the Alcohol Reduction Strategies- Current Confidence Questionnaire (ARS-CC) at Week 21
|
4.04 score on a scale
Standard Deviation 0.83
|
3.88 score on a scale
Standard Deviation 0.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Feelings about Being LGBTQIA2S+ is a validated, self-report measure which assesses an individual's feelings toward the future as an LBGTQIA2S+ individual. Participants are asked to rate the likelihood of experiencing positive life outcomes as an LBGTQIA2S+ individual on a scale of 1 (definitely no) to 4 (definitely yes). Response items are averaged to provide an overall score, with higher scores indicating a more positive outlook. The range is 1 to 4.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Hope for the Future as Measured by the Feelings About Being LGBTQIA2S+ at Week 21
|
3.34 score on a scale
Standard Deviation 0.55
|
3.25 score on a scale
Standard Deviation 0.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Drinking Motives Questionnaire- Revised (DMQ-R) assesses the extent to which a participant uses alcohol to cope with negative emotions. Participants indicate how often they experience a given motive for drinking on a scale of 0 (almost never/never) to 5 (almost always/always). Scale scores are calculated as the sum of the respective items, with higher scores indicating a greater likelihood that a participant uses alcohol to cope with negative emotions. The range is 0 to 5.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Drinking Motives at Week 21
|
1.02 score on a scale
Standard Deviation 0.89
|
1.04 score on a scale
Standard Deviation 1.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Drinking Refusal Self-Efficacy Questionnaire- Shortened Adolescent Version (DRSEQ-SRA) assesses individual capacity to resist alcohol use. Given a scenario, participants rate their ability to refuse alcohol from "I am very sure I could NOT resist drinking" to "I am very sure I could resist drinking". Two subscales are provided: social pressure, emotional relief. Total and subscale scores are calculated by summing item responses on the total measure and respective subscales. The range for both social pressure and emotional relief subscales is 6 to 36. Higher scores in both subscales indicate higher levels of drinking refusal self-efficacy. Higher scores indicate higher levels of drinking refusal self-efficacy.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Drinking Refusal Skills at Week 21
Social pressure
|
14.63 score on a scale
Standard Deviation 3.84
|
14.42 score on a scale
Standard Deviation 4.05
|
|
Drinking Refusal Skills at Week 21
Emotional relief
|
15.88 score on a scale
Standard Deviation 3.59
|
16.25 score on a scale
Standard Deviation 3.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Alcohol Use: Likelihood to Intervene assesses the capacity to intervene in situations of alcohol abuse and addiction. Participants are asked to rate how likely they would be to intervene in specific situations on a scale of 1 (very unlikely) to 4 (very likely). Responses across items are averaged to provide an overall score, with a higher score indicating a greater capacity to intervene. The range is 1 to 4.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Alcohol Use Bystander Behavior at Week 21
|
3.66 score on a scale
Standard Deviation 0.55
|
3.63 score on a scale
Standard Deviation 0.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Drinking Norms Rating Form, adjusted to LGBTQIA2S+ populations, assesses an individual's perception of drinking behavior of LGBTQIA2S+ teens. Participants indicate what percentage of LGBTQIA2S+ teens they believe engage in specific drinking behaviors. Percentages are averaged to indicate perception ranging from 0 = 0 times to 9 = 40+ times. We recoded the response scale using the mid-point of the response options. The range is 0 to 40. Higher scores represent higher levels of perception of social norms.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Accurate Perceptions of Alcohol Use at Week 21
|
4.48 score on a scale
Standard Deviation 6.79
|
6.04 score on a scale
Standard Deviation 8.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Multi-Group Ethnic Identity Measure assesses adolescents' perceived affirmation and sense of belonging to their ethnic identity. Participants indicate how much they agree on a five point scale with each of 13 statements about their ethnic identity. Mean scores were created for each subscale and higher scores represented higher levels of cognitive clarity, affective pride, or behavioral engagement. The ranges are all from 1 to 5.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Ethnic Identity at Week 21
Cognitive clarity
|
3.47 score on a scale
Standard Deviation 0.84
|
3.27 score on a scale
Standard Deviation 1.09
|
|
Ethnic Identity at Week 21
Affective pride
|
3.63 score on a scale
Standard Deviation 0.94
|
3.38 score on a scale
Standard Deviation 1.19
|
|
Ethnic Identity at Week 21
Behavioral engagement
|
3.32 score on a scale
Standard Deviation 0.88
|
3.02 score on a scale
Standard Deviation 1.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Outness Inventory for Sexual Orientation World Subscale is a modified measures that determine to what extent an individual's social network knows about the sexual orientation of the individual. Scores are analyzed as a sum of individuals and groups who are aware of the individual's sexual orientation. The range is 0 to 4. Higher scores indicate higher levels of outness.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Identity Concealment Behaviors as Measured by the Outness Inventory for Sexual Orientation World Subscale at Week 21
|
1.86 score on a scale
Standard Deviation 0.83
|
1.79 score on a scale
Standard Deviation 0.90
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Outness Inventory for Gender Identity Family Subscale is a modified measure that determine to what extent an individual's family members know about the gender identity of the individual. A summed total composite score was used to create a mean average score. The range is 0 to 1. Higher scores indicate higher levels of outness.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Identity Concealment Behaviors as Measured by the Outness Inventory for Gender Identity Family Subscale at Week 21
|
0.89 score on a scale
Standard Deviation 0.32
|
0.77 score on a scale
Standard Deviation 0.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 21Population: This number reflects the final number of participants in Week 21; 61 participants lost to attrition throughout the study.
The Outness Inventory for Gender Identity Family Subscale is a modified measures that determine to what extent an individual's social networks knows about the gender identity of the individual. Scores are analyzed as a sum of individuals and groups who are aware of the individual's gender identity. The range is 0 to 4. Higher scores indicate higher levels of outness.
Outcome measures
| Measure |
Intervention
n=170 Participants
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
|
Waitlist Control
n=83 Participants
Check-ins/provision of resources
|
|---|---|---|
|
Identity Concealment Behaviors as Measured by the Outness Inventory for Gender Identity World Subscale at Week 21
|
1.87 score on a scale
Standard Deviation 1.10
|
1.82 score on a scale
Standard Deviation 1.10
|
Adverse Events
Treatment Condition
Waitlist Control
Waitlist Control: Treatment Condition
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Condition
n=204 participants at risk
The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.
Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM): The intervention focuses on psycho-education (provision of accurate information about LGBTQIA2S+ people, education about the effects of alcohol), fostering positive identity development for LGBTQIA2S+ youth (e.g., fostering pride in identity, exposure to positive adult role models), teaching of alcohol use and sexual refusal skills, correction of inaccurate social norms about alcohol use and dating violence, teaching assertive communication skills, teaching emotion coping skills, mindfulness and grounding skills, and teaching bystander intervention skills related to dating/sexual violence and alcohol use..
|
Waitlist Control
n=100 participants at risk
Check-ins/provision of resources
|
Waitlist Control: Treatment Condition
n=16 participants at risk
Received PRYSHM program intervention following the completion of ALL data collection.
|
|---|---|---|---|
|
Social circumstances
Other (Not Including Serious) Adverse Events
|
0.49%
1/204 • Number of events 1 • Data on adverse events were collected throughout the study from baseline (enrollment 1-2 weeks before programming), during intervention (9-week programming), post-program survey (within 3 weeks of program end), 3-month follow-up from baseline, and during waitlist control intervention programming (at month 12 (9-weeks of programming)).
All-Cause Mortality is not a possible outcome of this trial.
|
0.00%
0/100 • Data on adverse events were collected throughout the study from baseline (enrollment 1-2 weeks before programming), during intervention (9-week programming), post-program survey (within 3 weeks of program end), 3-month follow-up from baseline, and during waitlist control intervention programming (at month 12 (9-weeks of programming)).
All-Cause Mortality is not a possible outcome of this trial.
|
0.00%
0/16 • Data on adverse events were collected throughout the study from baseline (enrollment 1-2 weeks before programming), during intervention (9-week programming), post-program survey (within 3 weeks of program end), 3-month follow-up from baseline, and during waitlist control intervention programming (at month 12 (9-weeks of programming)).
All-Cause Mortality is not a possible outcome of this trial.
|
Additional Information
Katie M Edwards, PhD
University of Nebraska-Lincoln, Department of Educational Psychology/Interpersonal Violence Research Laboratory
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place