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Evaluation of the Close to Home Program in California

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05206994
Recruitment Status : Enrolling by invitation
First Posted : January 25, 2022
Last Update Posted : April 4, 2022
Sponsor:
Collaborators:
Community Beyond Violence
Sierra Community House
Alliance for Community Transformations
Lumina Alliance
Strength United
Center for Community Solutions
California Department of Public Health
ValorUS
Community Solutions
East Los Angeles Womens Center
4-H
Information provided by (Responsible Party):
Jay G. Silverman, PhD, University of California, San Diego

Brief Summary:
Investigators propose to rigorously evaluate the Close to Home (C2H) model via a cluster-matched control trial across 18 diverse communities (9 C2H, 9 control) in California via collection and analyses of social network, school-based and social media data. Close to Home is a primary prevention community mobilization model implemented in 10 communities across California that engages community members across multiple sectors and social networks to strengthen community connections and shift social norms regarding sexual violence (SV), but has never been rigorously evaluated. C2H moves beyond criminal justice, lobbying, or school-based curricular approaches, taking a true community-level and community-led approach. This is a five-year project, funded by the Centers for Disease Control and Prevention (CDC) for 3 years with competitive awards for years 4 and 5, and is conducted in partnership with the California Department of Public Health (CDPH) and ValorUs (formerly CALCASA). The University of California, San Diego (UCSD) and CDPH partnership is uniquely poised to conduct the first rigorous evaluation of C2H in California at this time.

Condition or disease Intervention/treatment Phase
Sexual Violence Sexual Assault Adolescent Behavior Behavioral: Close to Home Not Applicable

Detailed Description:

Investigators propose to rigorously evaluate the Close to Home (C2H) model via a cluster-matched control trial across 18 diverse communities (9 C2H, 9 control) in California via collection and analyses of social network, school-based and social media data. Analyses of these data will provide evidence at the individual, interpersonal and community levels of the effectiveness of this community mobilization approach to reduce sexual violence (SV) incidence. California is uniquely poised to conduct this research, given a) the multiple, diverse of communities implementing C2H; b) California Department of Public Health (CDPH)'s 10-year commitment to building capacity to support local implementation of this model, and c) CDPH's ongoing partnership on RPE evaluation with University of California San Diego's Center on Gender Equity and Health, a center with the highest levels of expertise in evaluation of SV prevention programs, and the science of social norms, social networks and social media. A Research Advisory Board will be engaged and inform and guide these efforts throughout the project period. Investigators will accomplish this highly innovative effort via the following aims:

AIM 1. Develop and implement a cluster-matched control design in partnership with the RAB, including collecting baseline social network, school-based and social media data across 14 diverse California communities.

Hypothesis 1.1: Analyses of baseline social network data will demonstrate pathways of influence regarding SV social norms and behaviors among male and female youth ages 14-24 years.

Hypothesis 1.2: Analyses of triangulated YouGov and Twitter data will yield a valid, feasible social media-based assessment of SV social norms at the community-level for evaluation of SV prevention efforts.

AIM 2: Evaluate effects of the C2H model on SV social norms and incidence, as well as patterns of diffusion of these effects, via longitudinal analyses of social network data.

Hypothesis 2.1: Social norms rejecting SV will increase, and 12-month incidence of SV will decrease at 24-month follow-up among C2H participants relative to those in control programs, and these effects will diffuse via paths of influence across social networks assessed via Aim 1.

AIM 3: Extend Aim 2 findings via analyses of multiple waves of school-based data and geocoded social media data to yield multiple tests of community-level effects of C2H on SV social norms and incidence.

Hypotheses 3.1: Analyses of data from the California Healthy Kids Survey (ages 14-19 yrs) and Twitter (>13 yrs) collected from C2H and control communities (coincident with baseline and 24-month follow-up social network data) will yield evidence of community-level effects of C2H on SV social norms and incidence consistent with individual and network-level effects observed via Aim 2 analyses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Close to Home (C2H) is a primary prevention community mobilization model that engages community members across multiple sectors and social networks to strengthen community connections and shift social norms regarding SV, but has never been rigorously evaluated. C2H moves beyond criminal justice, lobbying, or school-based curricular approaches, taking a true community-level and community-led approach.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Close to Home Program in California: Assessing the Impact of Community Mobilization to Prevent Sexual Violence at the Individual, Social Network, and Community Levels
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : March 30, 2024
Estimated Study Completion Date : March 30, 2024

Arm Intervention/treatment
Experimental: Close to Home Intervention
Sites receiving the intervention arm were determined prior to the initiation of the research. The rape crisis center in each community applied for funding from the California Department of Public Health to implement the Close to Home model in their community and they were accepted via a competitive application process. Close to Home (C2H) is a community mobilization model developed in Boston and adapted for California and is specifically designed to prevent SV by strengthening community social connections and engaging whole communities in dialogue and action to transform social norms.
Behavioral: Close to Home
Close to Home (C2H), a community mobilization model developed in Boston and adapted for California, is specifically designed to prevent SV by strengthening community social connections and engaging whole communities in dialogue and action to transform social norms. The C2H model guides communities through four phases: 1) Assess, 2) Talk, 3) Build, and 4) Act. C2H mobilizes diverse groups of people residing in a shared geography and linked by social and political ties to engage in joint actions for SV prevention

No Intervention: Control Program

The control program is the 4-H Youth Development Program, which is implemented across every county in California via the University of California Cooperative Extension. In 4-H programs, kids and teens complete hands-on projects in areas like health, science, agriculture and civic engagement in a positive environment where they receive guidance from adult mentors and are encouraged to take on proactive leadership roles. The model does not use community mobilization and does not address sexual violence.

Control communities were selected based on propensity score matching using sociodemographic and community-level variables related to risk for sexual violence. The closest match was recruited first, and a next-best match was used if the first match declined participation.




Primary Outcome Measures :
  1. Virtual/Online Sexual Harassment - Digital Dating Abuse Scale [ Time Frame: 2 years ]
    Two item measure sexual harassment victimization and six items measure perpetration online, over text, or through social media. Response options: yes, in the last 12 months; yes, prior to last 12 months; never. Items used are adapted from the Digital Dating Abuse Scale - Reed, L. A., Tolman, R. M., & Ward, L. M. (2017). Gender matters: Experiences and consequences of digital dating abuse victimization in adolescent dating relationships. Journal of adolescence, 59, 79-89.

  2. In-Person Sexual Harassment & Violence - Sexual Harassment & Violence Scale [ Time Frame: 2 years ]
    One item measures in-person sexual harassment victimization and three items measure perpetration. Response options: yes, in the last 12 months; yes, prior to last 12 months; never. Items were adapted from Mitchell, K. J., Ybarra, M. L., & Korchmaros, J. D. (2014). Sexual harassment among adolescents of different sexual orientations and gender identities. Child abuse & neglect, 38(2), 280-295 and Miller, E., Jones, K. A., Ripper, L., Paglisotti, T., Mulbah, P., & Abebe, K. Z. (2020). An athletic coach-delivered middle school gender violence prevention program: A cluster randomized clinical trial. JAMA pediatrics, 174(3), 241-249.

  3. Dating Violence Victimization- Coaching Boys into Men Modified Dating Violence Victimization/Perpetration Scale [ Time Frame: 2 years ]
    Two items measure dating violence victimization. Response options: yes, in the last 12 months; yes, prior to last 12 months; never. Items were adapted from Miller, E., Jones, K. A., Ripper, L., Paglisotti, T., Mulbah, P., & Abebe, K. Z. (2020). An athletic coach-delivered middle school gender violence prevention program: A cluster randomized clinical trial. JAMA pediatrics, 174(3), 241-249.

  4. Dating Violence Perpetration- Coaching Boys into Men Modified Dating Violence Victimization/Perpetration Scale [ Time Frame: 2 years ]
    Four items measure perpetration. Response options: yes, in the last 12 months; yes, prior to last 12 months; never. Items were adapted from Miller, E., Jones, K. A., Ripper, L., Paglisotti, T., Mulbah, P., & Abebe, K. Z. (2020). An athletic coach-delivered middle school gender violence prevention program: A cluster randomized clinical trial. JAMA pediatrics, 174(3), 241-249.

  5. Sexual Violence Victimization/Perpetration - Coaching Boys into Men Modified Perpetration Scale [ Time Frame: 2 years ]
    One item measures in-person sexual violence victimization and twp items measure perpetration. Response options: yes, in the last 12 months; yes, prior to last 12 months; never. Items were adapted from Miller, E., Jones, K. A., Ripper, L., Paglisotti, T., Mulbah, P., & Abebe, K. Z. (2020). An athletic coach-delivered middle school gender violence prevention program: A cluster randomized clinical trial. JAMA pediatrics, 174(3), 241-249.

  6. LGBTQ+ and Gender Minority Violence- Victimization Scale [ Time Frame: 2 years ]
    Nine items measure specific forms of sexual violence and harassment victimization experienced by sexual and gender minority youth. Response options: yes, in the last 12 months; yes, prior to last 12 months; never. Items adapted from Peitzmeier SM, Wirtz AL, Humes E. et al. The transgender-specific intimate partner violence scale for research and practice: Validation in a sample of transgender women. Social Science & Medicine. 2021. 291: 114495. https://doi.org/10.1016/j.socscimed.2021.114495 and Scheer J, Woulfe JM, Goodman LA. Psychometric validation of the identity abuse scale among LGBTQ individuals. Community Psychology. 2018.


Secondary Outcome Measures :
  1. Social Norms- Sexual Violence Social Norms Scale [ Time Frame: 2 years ]
    Four item scale assessing injunctive social norms related to perceived acceptability of SV among peers developed for this study; not yet validated.

  2. Social Norms- Shared Concern about Sexual and Dating Violence Scale [ Time Frame: 2 years ]
    Three item measure of social norms related to expectations of people's actions around preventing sexual and dating violence in the community (descriptive norm). Response options: 6-point Likert scale; strongly disagree to strongly agree. Adapted from Lippman 2016. Development, Validation, and Performance of a Scale to Measure Community Mobilization. Soc Sci Med. 2016 May ; 157: 127-137. doi:10.1016/j.socscimed.2016.04.002

  3. Social Cohesion Scale [ Time Frame: 2 years ]
    Two item measure of perceived social cohesion in community. Response options: 6-point Likert scale; strongly disagree to strongly agree. Items adapted from Banyard, Edwards. 2019. "What would the neighbors do?" Measuring sexual and domestic violence prevention social norms among youth and adults https://onlinelibrary.wiley.com/doi/full/10.1002/jcop.22201; Yes change: Banyard, Edwards, Rizzo 2020. Improving Social Norms and Actions to Prevent Sexual and Intimate Partner Violence: A Pilot Study of the Impact of Green Dot Community on Youth https://journals.sagepub.com/doi/full/10.1177/2632077020966571

  4. Community Connectedness Scale [ Time Frame: 2 years ]
    Four items assessing perceived connection to fellow youth in the intervention program. Response options: 6-point Likert scale; strongly disagree to strongly agree. Adapted from Lippman 2016. Development, Validation, and Performance of a Scale to Measure Community Mobilization. Soc Sci Med. 2016 May ; 157: 127-137. doi:10.1016/j.socscimed.2016.04.002

  5. Sense of Belonging Scale [ Time Frame: 2 years ]
    Two items measuring sense of belonging to the community. Response options: 6-point Likert scale; strongly disagree to strongly agree. Adapted from Fujiwara, T., & Kawachi, I. (2008). Social capital and health: a study of adult twins in the US. American journal of preventive medicine, 35(2), 139-144.

  6. Sense of Community Scale [ Time Frame: 2 years ]
    Six item scale measuring sense of community connectedness. Response options: 6-point Likert scale; strongly disagree to strongly agree. Adapted from Peterson, N.A., Speer, P.W., & Hughey, J. (2006). Measuring sense of community: A methodological interpretation of the factor structure debate. Journal of Community Psychology, 34, 453-469.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be between 14-24 years old
  • Must be enrolled in program with partner organization(s) or have been nominated by a peer enrolled in the partner programs
  • Provide informed consent to participate

Exclusion Criteria:

  • Under age 14
  • Over age 24

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): NCT05206994


Locations
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United States, California
Dr. Jay Silverman
San Diego, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Community Beyond Violence
Sierra Community House
Alliance for Community Transformations
Lumina Alliance
Strength United
Center for Community Solutions
California Department of Public Health
ValorUS
Community Solutions
East Los Angeles Womens Center
4-H
Investigators
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Principal Investigator: Jay G Silverman, PhD University of California, San Diego
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Responsible Party: Jay G. Silverman, PhD, Professor of Global Public Health, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05206994    
Other Study ID Numbers: 201920S
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jay G. Silverman, PhD, University of California, San Diego:
Intimate Partner Violence