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Adolescent BehaviorHRP-ENCT05167344

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

A study testing Healthy Relationships Program-Enhanced in people with Adolescent Behavior and Dating Violence, run by Western University, Canada at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 21 years
Conditions the study is for
Adolescent Behavior, Dating Violence
What is being tested?
Healthy Relationships Program-Enhanced
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteCanada
Study dates
14 Apr 2022to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Western University

    London, Ontario, N6G 1G7

    Meghan Fournie, MHIS, 519-661-2111 ext. 84360, mfourni8@uwo.ca

    Claire Crooks, PhD, ccrooks@uwo.ca

    Recruiting

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Healthy Relationships Program-Enhanced
Keywords
vulnerable youth, social-emotional functioning, dating violence, mental health
Medical subject headings
Adolescent Behavior, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Relationships Program-EnhancedBehavioural

    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.

Study groups in NCT05167344
Study groupRoleWhat they receive
Healthy Relationships Program-Enhanced (HRP-E)ExperimentalYouth participating in the HRP-E and facilitators delivering in the program
Receives: Behavioral: Healthy Relationships Program-Enhanced

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive social-emotional functioning

    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.

    Measured: Change from baseline to one-month post program completion (up to 20 weeks)

Secondary outcomes (5)
  1. Dating Violence

    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).

    Measured: Change from baseline to one-month post program completion (up to 20 weeks)

  2. Help-seeking intentions

    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.

    Measured: Change from baseline to one-month post program completion (up to 20 weeks)

  3. Actual help-seeking

    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.).

    Measured: Change from baseline to one-month post program completion (up to 20 weeks)

  4. Positive mental health

    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.

    Measured: Change from baseline to one-month post program completion (up to 20 weeks)

  5. Emotional distress

    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.

    Measured: Change from baseline to one-month post program completion (up to 20 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start14 Apr 2022
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Youth and facilitators participating in HRP-E program (intervention arm)
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167344
Sponsor's protocol ID
WREM 120133
Acronym
HRP-E
Status last verified
May 2022
First submitted
10 Nov 2021
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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

  • 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.

    PubMed 21652072
  • 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.

    PubMed 25840436
  • Smyth, P. (2017). Working with high-risk youth: A relationship-based practice framework. Routledge Academic. London: Routledge, https://doi.org/10.4324/9781315270043

  • 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.

    PubMed 19167066
  • 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.

    PubMed 19652099
  • 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.

    PubMed 22057307

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Relationships Program-Enhanced in people with Adolescent Behavior and Dating Violence, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claire Crooks (519-661-2111 ext. 89245, ccrooks@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive social-emotional functioning (time frame: Change from baseline to one-month post program completion (up to 20 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05167344, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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