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Evaluation of PRYSHM for LGBTQIA2S+ Youth (PRYSHM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05521906
Recruitment Status : Recruiting
First Posted : August 30, 2022
Last Update Posted : January 30, 2023
Sponsor:
Collaborators:
University of Houston
University of Colorado, Colorado Springs
Information provided by (Responsible Party):
Katie Edwards, University of Nebraska Lincoln

Brief Summary:
The overarching goal of the proposed project is to develop an innovative, online synchronous DV and AU prevention curriculum created specifically for SGMY (ages 15 to 18); conduct a pilot randomized controlled trial to assess its feasibility and acceptability of the intervention and study procedures; identify preliminary outcomes of the intervention; and ensure that the intervention is working equally well for SGMY of color.

Condition or disease Intervention/treatment Phase
Dating Violence Alcohol Drinking Behavioral: Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: SGMY (N=300) are randomly assigned to a treatment (n=200) or wait-list (n=100) control condition.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development and Pilot Evaluation of an Online Intervention to Prevent Dating Violence and Problem Drinking in Sexual Minority Youth
Actual Study Start Date : September 21, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Treatment Condition
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.
Behavioral: 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..

No Intervention: Control
Check-ins/provision of resources



Primary Outcome Measures :
  1. Change from Baseline in Intimate partner violence perpetration at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 month (at Week 9) or past three months (at Baseline and Week 21). The following subscales are generated from the measure: social control, physical abuse, sexual abuse, isolation, cyber control, and intimidation. Change = (Week 9 score - baseline; Week 21- baseline).

  2. Change from Baseline in Intimate partner violence victimization at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 month (at Week 9) or past three months (at Baseline, Week 21). Scores generate the following subscales: privacy control, social control, physical abuse, sexual abuse, intimidation. Change = (Week 9- baseline; Week 21- baseline).

  3. Change from Baseline in Alcohol Use at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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, and within 30 days on a scale of "0" to "40+". Change = (Week 9- baseline; Week 21- baseline)

  4. Change from Baseline in Sexual and Gender Minority Specific Intimate Partner Violence Perpetration at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 month (at Week 9) or past three months (at Baseline, Week 21). Change = (Week 9- baseline; Week 21- baseline).

  5. Change from Baseline in Sexual and Gender Minority Specific Intimate Partner Violence Victimization at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 or gender minority experiences intimate partner violence. Participants rate how frequently they have experienced intimate partner violence from 0 to 100 times in the past month (at Week 9) or past three months (at Baseline, Week 21). Change = (Week 9- baseline; Week 21- baseline).

  6. Change from Baseline in Drinking Intentions at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 month (Week 9) or three months (Baseline and Week 21) on a scale of "definitely will" to "definitely won't". Change = (Week 9- baseline; Week 21- baseline).

  7. Change from Baseline in Willingness to Drink at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 "not at all" to "very willing" given a specific scenario. Change = (Week 9- baseline; Week 21- baseline).


Secondary Outcome Measures :
  1. Change from Baseline in Experience of Negative Consequences as a Result of Alcohol Use at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 month (at Week 9) or past three months (at Baseline and Week 21) with a "yes" or "no" answer. The number of "yes" responses provides an indication of the severity of alcohol-related consequences. Change = (Week 9 score - baseline score; Week 21 score - baseline score).

  2. Change from Baseline in Depressive Symptoms at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9 score - baseline score; Week 21 score - baseline score).

  3. Change from Baseline in Drug Use at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 month (at Week 9) or past three months (at Baseline, Week 21) with either 1) yes or 2) no. A dichotomous item will be made for the two items to indicate if the participant has engaged in drug use for a given timeframe. Change = (Week 9 score - baseline score, Week 21 score - baseline score).

  4. Change from Baseline in Sexual Risk-Taking as Measured by the Sexual Risk Survey at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 month (at week 9) or past three months (baseline, week 21) on a scale of "0" to "30+". Scores are analyzed at the item level. Change = (Week 9 score - baseline score; Week 21 score - baseline score).


Other Outcome Measures:
  1. Change from Baseline in Identity Concealment Behaviors as Measured by the Outness Inventory for Sexual Orientation and the Outness Inventory for Gender Identity at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    The Outness Inventory for Sexual Orientation and the Outness Inventory for Gender Identity are two modified measures that determine to what extent an individual's social network knows about the sexual orientation and/or gender identity of the individual. Scores are analyzed as a sum of individuals and groups who are aware of the individual's sexual orientation and/or gender identity. Change = (Week 9 score - baseline score; Week 21 score - baseline score).

  2. Change from Baseline in Experiences of Internalized Homonegativity at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9 score - baseline score; Week 21 score - baseline score).

  3. Change from Baseline in Sense of LGBTQIA2S+ Community at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 are averaged to provide a score for that subscale. Change = (Week 9 score - baseline score; Week 21 score - baseline score).

  4. Change from Baseline in Emotional Regulation and Coping at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9- baseline; Week 21- baseline).

  5. Change from Baseline in Conflict Resolution Skills as Measured by the Communication Skills Test at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9 score - baseline score; Week 21 score - baseline score).

  6. Change from Baseline in Sexual Refusal Skills at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9- baseline; Week 21- baseline).

  7. Change from Baseline in Bystander Behavior at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 "very unlikely" to "very likely". The measure provides two subscales: reactive and proactive. Subscale scores are calculated by summing item responses on the respective subscale. Change = (Week 9- baseline; Week 21- baseline).

  8. Change from Baseline in Accurate Perceptions of Dating Violence at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9- baseline; Week 21- baseline).

  9. Change from Baseline in Protective Behavioral Strategies as Measured by the Alcohol Reduction Strategies- Current Confidence Questionnaire (ARS-CC) at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 scale of 1 (not at all confident) to 5 (completely confident). Responses are averaged to provide an overall score, with a higher average indicating a greater capacity to utilize alcohol reduction strategies. Change = (Week 9 score - baseline score; Week 21 score - baseline score).

  10. Change from Baseline in Hope for the Future as Measured by the Feelings about Being LGBTQIA2S+ at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9 score - baseline score; Week 21 score - baseline score).

  11. Baseline measure in Family Rejection [ Time Frame: Baseline ]
    The Family Rejection: LGBT-Specific is a modified, self-report measured based on Ryan, et al. (2010) which assesses an individual's perception of family rejection based on their status as a member of the LBGTQIA2S+ community. Participants are asked to rate how often they experience specific negative interactions with family members on a scale of 0 (never) to 2 (often). Responses are dichotomized as either "occurring" or "not occurring", and items are summed, with a higher score indicating greater family rejection. We measure for a baseline score.

  12. Change from Baseline in Drinking Motives at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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 1 (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. Change = (Week 9- baseline; Week 21- baseline).

  13. Change from Baseline in Drinking Refusal Skills at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9- baseline; Week 21- baseline).

  14. Change from Baseline in Alcohol Use Bystander Behavior at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9- baseline; Week 21- baseline).

  15. Change from Baseline in Accurate Perceptions of Alcohol Use at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9- baseline; Week 21- baseline).

  16. Change from Baseline in Ethnic Identity at Week 9 and Week 21 [ Time Frame: Baseline, Week 9, and Week 21 ]
    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. Change = (Week 9- baseline; Week 21- baseline).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identify as LGBTQIA2S+ (sexual and/or gender minority), and/or report being unsure of their sexual orientation, and/or report experiencing romantic/sexual attraction to someone of the same sex assigned at birth.
  • Age between 15 and 18 years.
  • Ability to read and speak in English.
  • Current residence in the United States.
  • Consistent access to an electronic device (e.g., smartphone, tablet, computer) with high speed Internet access and/or Wi-Fi.
  • Ability to attend 9 weekly, one hour online intervention sessions.
  • Recent or currently in a dating/romantic/sexual relationship (past three months).
  • Not at high risk for suicide (as defined by not endorsing a critical item on a past-month suicide screening measure [SBQ-R], and/or not be deemed at elevated risk for suicide on the basis of a clinical interview,)

Exclusion Criteria:

  • Age under 15 or over 18 years.
  • Identify as heterosexual and cisgender.
  • Current enrollment as a full-time college student.
  • Lack of English language proficiency (either written and/or spoken).
  • Current residence outside of the U.S.
  • No current or recent (in past three months) dating/romantic/sexual relationship.
  • No consistent access to an electronic device (e.g., smartphone, tablet, computer) with high speed Internet or Wi-Fi.
  • Inability to attend scheduled weekly one hour intervention sessions.
  • Elevated risk of suicidality (reporting a past month suicide attempt or past month suicide threat with intent to die on the SBQ-R or determined to be at elevated current risk for suicidality based on a clinical interview).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05521906


Locations
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United States, Nebraska
University of Nebraska (Lincoln) Recruiting
Lincoln, Nebraska, United States, 68583-0858
Contact: Katie M Edwards, Ph.D.    603-422-3207    katie.edwards@unl.edu   
Sub-Investigator: Heather Littleton, Ph.D.         
Sub-Investigator: Clayton Neighbors, Ph.D.         
Sponsors and Collaborators
Katie Edwards
University of Houston
University of Colorado, Colorado Springs
Publications:
Edwards KM, Banyard VL, Sessarego SN. Dating and sexual violence victimization and perpetration among high school youth: Incidence and correlates. Manuscript in preparation. 2017.
Mason TB, Lewis RJ, Gargurevich M, Kelley ML. Minority stress and intimate partner violence perpetration among lesbians: Negative affect, hazardous drinking, and intrusiveness as mediators. Psychology of Sexual Orientation and Gender Diversity. 2016;3(2):236-246.
Edwards KM, Sylaska KM, Neal AM. Intimate partner violence among sexual minority populations: A critical review of the literature and agenda for future research. Psychology of Violence. 2015;5(2):112-121.
Lewis RJ, Millentich RJ, Kelley ML, Woody A. Minority stress, substance use, and intimate partner violence among sexual minority women. Aggression and Violent Behavior. 2012;17:247-256.
Lin Y, J., Israel T. Development and validation of a psychological sense of LGBT community scale. Journal of Community Psychology. 2012;40(5):14.
Noar SM, Pierce LB, Black HG. Can computer-mediated interventions change theortical mediators of safer sex? A meta-analysis. Human Communication Research. 2010;36:36.
Growing up LGBT in America: NCOD report. Human Rights Campaignn.
GLSEN. The 2015 national school climate survey: Executive summary. GLSEN;2015.
Lenhart A. A majority of American teens report access to a computer, game console, smartphone and a tablet. Washington, DC: Pew Research Center. 2015.

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Responsible Party: Katie Edwards, Associate Professor, University of Nebraska Lincoln
ClinicalTrials.gov Identifier: NCT05521906    
Other Study ID Numbers: 21985IRB
First Posted: August 30, 2022    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD (using pseudoGUIDS) will be uploaded into the NIAAA data repository consistent with NIAAA policy for studies funded by NIAAA. The data in the NIAAA data archive are catalogued and made available to the general research community after a two year embargo period following the end date of the research award.
Time Frame: IPD will be available after a 2 year embargo period from the award end date. IPD will be available within the NIAAA data archive in perpetuity.
Access Criteria: To access to IPD from within the NIAAA data archive, researchers will need to receive authorization by completing the NDA Data Access Request (DAR) and satisfying several pre-requisites. DARs will be reviewed by a special committee at NIAAA to ensure that the researcher has made an adequate case for the responsible use of the data. Individuals seeking access to IPD must be associated with an NIH recognized institution with an FWA and must provide a research-related need to access the data.
URL: https://nda.nih.gov/niaaa/getting-data-access.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior