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Evaluation of the Healthy Relationships Program-Enhanced (HRP-E) for Vulnerable Youth (HRP-E)

18 de mayo de 2022 actualizado por: Claire Crooks, Western University, Canada
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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

150

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Claire Crooks
  • Número de teléfono: 89245 519-661-2111
  • Correo electrónico: ccrooks@uwo.ca

Copia de seguridad de contactos de estudio

  • Nombre: Meghan Fournie
  • Número de teléfono: 84360 519-661-2111
  • Correo electrónico: mfourni8@uwo.ca

Ubicaciones de estudio

    • Ontario
      • London, Ontario, Canadá, N6G 1G7
        • Reclutamiento
        • Western University
        • Contacto:
          • Meghan Fournie, MHIS
          • Número de teléfono: 84360 519-661-2111
          • Correo electrónico: mfourni8@uwo.ca
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 21 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Healthy Relationships Program-Enhanced (HRP-E)
Youth participating in the HRP-E and facilitators delivering in the program
The Healthy Relationships Program-Enhanced (HRP-E) is a small group mental health promotion and healthy relationship program designed for vulnerable, at-risk youth. It is a trauma-informed, 16-session manualized program.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Positive social-emotional functioning
Periodo de tiempo: Change from baseline to one-month post program completion (up to 20 weeks)
Measured by the Social-Emotional Assets and Resiliency Scales-Adolescent (SEARS-A) that assesses social-emotional assets of responsibility, self-regulation, social competence, and empathy. Participants respond to the 35 items on a 4-point Likert scale (0 = never, 1 = sometimes, 2 = often, 3 = always). The combined total score ranges from 0 to 105 with higher scores indicating greater social-emotional strengths.
Change from baseline to one-month post program completion (up to 20 weeks)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dating Violence
Periodo de tiempo: Change from baseline to one-month post program completion (up to 20 weeks)
Dating violence perpetration as measured by the Conflict in Adolescent Dating Relationships Inventory (short form). Participants respond to the 20 items on a 4-point Likert scale (0 = never, 1 = seldom, 2 = sometimes, 3 = often). The sum of the perpetrator and victimization items are calculated (10 items each). Scores range from 0 to 30 with higher scores indicating a higher incidence of abusive behaviour (perpetrator items) or victim of abuse (victimization items).
Change from baseline to one-month post program completion (up to 20 weeks)
Help-seeking intentions
Periodo de tiempo: Change from baseline to one-month post program completion (up to 20 weeks)
Self-reported intentions to seek help as measured by General Help-seeking Questionnaire. Participants indicate their likelihood to seek help for a personal or emotional problem from the people listed on a 4-point Likert scale (1= very unlikely, 2=unlikely, 3=likely, 4=very likely). A mean score is calculated on the items with the higher score indicating a higher likelihood to seek help for a problem.
Change from baseline to one-month post program completion (up to 20 weeks)
Actual help-seeking
Periodo de tiempo: Change from baseline to one-month post program completion (up to 20 weeks)
Actual help-seeking over the past 2 weeks as measured by the Actual Help Seeking Questionnaire. Participants check the people they have sought help from over a two-week period for a personal or emotional problem and then describe the type of problem. A score for the total number of people they sought help from is calculated and open-ended descriptions are coded for type of problem (e.g., mental health, relationships, school, etc.).
Change from baseline to one-month post program completion (up to 20 weeks)
Positive mental health
Periodo de tiempo: Change from baseline to one-month post program completion (up to 20 weeks)
Emotional well-being and aspects of psychological and social functioning that occur within the past month as measured by the Adolescent Mental Health Continuum-Short Form. Participants rate 14 items on a 6-point Likert scale from 0=Never to 5 = Every day. Scores range from 0 to 70 with higher scores indicating higher experience of positive mental health.
Change from baseline to one-month post program completion (up to 20 weeks)
Emotional distress
Periodo de tiempo: Change from baseline to one-month post program completion (up to 20 weeks)
Stress and depression items from modified Depression Anxiety Stress Scales (DASS-21). Participants rate the 14 stress and depression items on a 4-point Likert scale from 0=never to 3 = more than two times. Total scores are calculated for the stress and depression subscales with a range of 0 to 21 with higher scores indicating higher stress or depression.
Change from baseline to one-month post program completion (up to 20 weeks)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Dr. Claire Croooks, PhD, Western University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de abril de 2022

Finalización primaria (Anticipado)

1 de abril de 2023

Finalización del estudio (Anticipado)

1 de abril de 2023

Fechas de registro del estudio

Enviado por primera vez

10 de noviembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

7 de diciembre de 2021

Publicado por primera vez (Actual)

22 de diciembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de mayo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

18 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • WREM 120133

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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