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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Western University
London, Ontario, N6G 1G7
Meghan Fournie, MHIS, 519-661-2111 ext. 84360, mfourni8@uwo.ca
Claire Crooks, PhD, ccrooks@uwo.ca
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.
- Conditions
- Adolescent Behavior, Dating Violence
- 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 group | Role | What they receive |
|---|---|---|
| Healthy Relationships Program-Enhanced (HRP-E) | Experimental | Youth 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.
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)
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)
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)
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)
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)
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.
- First posted22 Dec 2021
- Study start14 Apr 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Crooks, Western University, Canada
- Investigators
- Dr. Claire Croooks, PhD, Principal investigator, Western University
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 21652072Crooks 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 25840436Smyth, 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 19167066Wolfe 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 19652099Wolfe 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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Healthy Relationships Program-Enhanced (HRP-E) for Vulnerable Youth
- ClinicalTrials.gov ID
- NCT05167344
- Acronym / sponsor ID
- HRP-E / WREM 120133
- Conditions
- Adolescent Behavior, Dating Violence
- Keywords
- vulnerable youth, social-emotional functioning, dating violence, mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Youth and facilitators participating in HRP-E program (intervention arm)
| Arm | Type | Receives |
|---|---|---|
| Healthy Relationships Program-Enhanced (HRP-E) | Experimental | Behavioral: Healthy Relationships Program-EnhancedYouth participating in the HRP-E and facilitators delivering in the program |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Youth with low literacy or cognitive functions who may not be able to complete the self-report measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Relationships Program-EnhancedThe 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. | Behavioural | Healthy Relationships Program-Enhanced (HRP-E) |
Primary outcome
Positive social-emotional functioning
Time frame: 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.
5 secondary outcomes
Dating Violence
Time frame: Change from baseline to one-month post program completion (up to 20 weeks)
Help-seeking intentions
Time frame: Change from baseline to one-month post program completion (up to 20 weeks)
Actual help-seeking
Time frame: Change from baseline to one-month post program completion (up to 20 weeks)
Positive mental health
Time frame: Change from baseline to one-month post program completion (up to 20 weeks)
Emotional distress
Time frame: Change from baseline to one-month post program completion (up to 20 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- BackgroundAndrews, 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
- BackgroundAntle, 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
- Background: PubMed 21652072Crooks 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.
- Background: PubMed 25840436Crooks 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.
- BackgroundSmyth, P. (2017). Working with high-risk youth: A relationship-based practice framework. Routledge Academic. London: Routledge, https://doi.org/10.4324/9781315270043
- Background: PubMed 19167066Wekerle 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.
- Background: PubMed 19652099Wolfe 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.
- Background: PubMed 22057307Wolfe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Claire Croooks, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
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.