Clinical trial NCT05167344: Evaluation of the Healthy Relationships Program-Enhanced (HRP-E) for Vulnerable Youth
Official title: Evaluation of the Healthy Relationships Program-Enhanced (HRP-E) for Vulnerable Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Behavior
Dating Violence
Keywords: vulnerable youth
social-emotional functioning
dating violence
mental health
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Youth and facilitators participating in HRP-E program (intervention arm)
Primary purpose: PREVENTION

Brief summary: Investigators will work with community partners to undertake an evaluation of the impact of the Healthy Relationships Program-Enhanced (HRP-E) for youth to build evidence on effective programming with diverse vulnerable youth populations in real-world contexts. Youth participants will complete four surveys before and after participating in the HRP-E program and an interview approximately 4 to 6 months after participating in the program. Program facilitators will also track session activities and youth participation throughout the program and are invited to participate in a survey after the program is complete.

Detailed description: Study Background and Design:

Vulnerable youth disproportionately experience dating violence, trauma, abuse, and maltreatment. Vulnerable youth are defined as youth at risk of, or currently experiencing, harm or adversities due to social and environmental factors. Youth who have experienced violence, trauma, abuse, and maltreatment have a more difficult time developing healthy, stable relationships in adolescence and beyond. They also often become involved in community mental health care, welfare care, and the justice system. Vulnerable youth are in need of programming to provide education and skill-building in areas such as healthy relationships, mental health, and substance use. Many stakeholders, including university-based researchers and community partners, recommend integrating mental health interventions into settings where youths are already receiving essential services (e.g., schools, child welfare agencies).

The Healthy Relationships Program-Enhanced (HRP-E) fills a gap in mental health promotion and healthy relationship programming. It is a trauma-informed, 16-session manualized program designed to be facilitated in small group settings by educators or community professionals. The program's core components derive from the evidence-based, Canadian Fourth R program, a classroom-based, universal healthy relationships promotion and dating violence prevention curriculum (Crooks et al., 2011, 2015; Wolfe et al., 2009, 2012). The HRP-Enhanced program has been successfully implemented in various settings (e.g., schools, youth corrections). However, the impact of the program on vulnerable youth has not been extensively studied and needs to be further examined to under the effectiveness of this program across diverse settings (e.g., community mental health services, child welfare services, juvenile justice).

Investigators will work with our community partners to undertake a mixed-methods evaluation, including repeated measures time-series survey and follow-up interviews, to examine the impacts of the HRP-Enhanced Program to build evidence on what type of programming works with diverse vulnerable youth populations. Program facilitators will track session activities and youth participation throughout the program, and participate in a post-program implementation. Specifically, investigators will be able to determine the extent to which the HRP-E promotes positive mental health and well-being among vulnerable youth and identify changes in social-emotional assets and resilience, youth well-being, mental health, dating violence and help-seeking.

Participants:

Youth participating in HRP-E and program facilitators are eligible to participate in this study. Investigators will work with each community partner to identify 2 to 4 HRP-E groups they are delivering to be invited to participate in this research study (a total of 20 groups). Approximately 100-150 youth are expected to participate in this study, and approximately 10 to 20 facilitators. The number of youth and facilitators will be dependent on the number of HRP-Enhanced groups delivered and the total number of youth participating in the program.

Procedures:

Youth will be invited to participate in three research activities: a survey at four time-points, individual interviews, and providing consent for the use of program session tracking information collected by facilitators on their participation in the program for research purposes. (note: the session tracking data are collected routinely by facilitators, so it is the use of those data that participants are consenting to, not the collection).

The survey is administered at four time-points: i) two weeks to one month before they start the program (baseline); ii) at the start of the program (pre-intervention); iii) at the end of the program (post-intervention), and; iv) one month after the end of the program (follow-up). The survey asks questions about youths' mental health and well-being, who they might seek support from, dating and dating violence, bullying, and questions about their identities. The interview will take place approximately 4 to 6 months after the youth completes the program. The semi-structured interview asks youth about their experiences participating in the program and any skills they have learned and used.

The session tracking data includes youths' attendance, perceived engagement (as rated by the facilitator), and any trauma-related behaviours shown in group (as rated by facilitator). If youth consent to the sharing of those data, they will be de-identified by facilitators and shared with a unique participant identifier (ID) to facilitate merging of data across sources.

Facilitators implementing the HRP-E program will be invited to share their quality improvement data from their session tracking sheets for research purposes. They are also invited to complete an online implementation survey at the end of the HRP-Enhanced group to understand their experiences implementing the program with the recent HRP group they facilitated. The survey includes questions regarding group and facilitator characteristics, group format and logistics, virtual considerations, modifications, and program impact.

Planned Analyses:

Investigators will explore the baseline and pre-intervention data through bivariate analyses to investigate significant differences in outcomes and regression to the mean. If no significant differences, a new time 1 variable will be calculated using the mean of time 1 and time 2. Bivariate comparisons will be completed between pre-intervention and post-intervention outcomes, as well as pre-intervention and follow-up outcomes. Effect sizes will be calculated using Cohen's d. Analyses will also include general linear model (GLM) repeated measures to examine potential gender effects and/or time-by-gender interactions related to post-intervention outcomes. Finally, chi-square analyses will be conducted to determine whether systematic attrition occurred.

Eligibility criteria: Inclusion Criteria:

* Youth participating in the Healthy Relationships Program-Enhanced
* Facilitators delivering the Healthy Relationships Program-Enhanced
* A minimum of three youth participating as a group in the Healthy Relationships Program-Enhanced

Exclusion Criteria:

* Youth with low literacy or cognitive functions who may not be able to complete the self-report measures

Primary outcomes:
measure: Positive social-emotional functioning
timeFrame: Change from baseline to one-month post program completion (up to 20 weeks)
Secondary outcomes:
measure: Dating Violence
timeFrame: Change from baseline to one-month post program completion (up to 20 weeks)
measure: Help-seeking intentions
timeFrame: Change from baseline to one-month post program completion (up to 20 weeks)
measure: Actual help-seeking
timeFrame: Change from baseline to one-month post program completion (up to 20 weeks)
measure: Positive mental health
timeFrame: Change from baseline to one-month post program completion (up to 20 weeks)
measure: Emotional distress
timeFrame: Change from baseline to one-month post program completion (up to 20 weeks)
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University
name: Dr. Claire Croooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrews, N., Pepler, D., Motz, M. (2019). Research and evaluation with community-based projects: Approaches, considerations, and strategies. American Journal of Evaluation, 40(4), 548-561. https://doi.org/10.1177/1098214019835821
citation: Antle, B. F., Sullivan, D. J., Dryden, A., Karam, E. A., & Barbee, A. P. (2011). Healthy relationship education for dating violence prevention among high-risk youth. Children and Youth Services Review, 33(1), 173-179. doi:10.1016/j.childyouth.2010.08.031
citation: Crooks CV, Scott K, Ellis W, Wolfe DA. Impact of a universal school-based violence prevention program on violent delinquency: distinctive benefits for youth with maltreatment histories. Child Abuse Negl. 2011 Jun;35(6):393-400. doi: 10.1016/j.chiabu.2011.03.002. Epub 2011 Jun 8.
citation: Crooks CV, Scott KL, Broll R, Zwarych S, Hughes R, Wolfe DA. Does an evidence-based healthy relationships program for 9th graders show similar effects for 7th and 8th graders? Results from 57 schools randomized to intervention. Health Educ Res. 2015 Jun;30(3):513-9. doi: 10.1093/her/cyv014. Epub 2015 Apr 2.
citation: Smyth, P. (2017). Working with high-risk youth: A relationship-based practice framework. Routledge Academic. London: Routledge, https://doi.org/10.4324/9781315270043
citation: Wekerle C, Leung E, Wall AM, MacMillan H, Boyle M, Trocme N, Waechter R. The contribution of childhood emotional abuse to teen dating violence among child protective services-involved youth. Child Abuse Negl. 2009 Jan;33(1):45-58. doi: 10.1016/j.chiabu.2008.12.006. Epub 2009 Jan 22.
citation: Wolfe DA, Crooks C, Jaffe P, Chiodo D, Hughes R, Ellis W, Stitt L, Donner A. A school-based program to prevent adolescent dating violence: a cluster randomized trial. Arch Pediatr Adolesc Med. 2009 Aug;163(8):692-9. doi: 10.1001/archpediatrics.2009.69.
citation: Wolfe DA, Crooks CV, Chiodo D, Hughes R, Ellis W. Observations of adolescent peer resistance skills following a classroom-based healthy relationship program: a post-intervention comparison. Prev Sci. 2012 Apr;13(2):196-205. doi: 10.1007/s11121-011-0256-z.