Evaluation of the Healthy Relationships Plus Program for Youth

Mental Health Wellness 1 Clinical Trial

Official title:

Evaluation of the Healthy Relationships Plus Program for Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140099
• Other study ID #: 146/2013
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2019
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adolescent risk behaviours, such as violence and substance use, are prevalent public health concerns in Canada. Further, these behaviours often co-occur, and are associated with poor mental health. However, the majority of prevention programs focus on preventing single issues and do not consider mental health, and also neglect the importance of relationships when promoting positive youth development. To address this gap, the Centre for Addiction and Mental Health (CAMH) Centre for Prevention Science designed the Fourth R Healthy Relationships Plus Program, a small group program focused on the promotion of positive mental health and the reduction of violence and substance use, via the development of improved communication, interpersonal and help-seeking skills. The purpose of this study is to evaluate the Fourth R Healthy Relationships Plus program using both outcome (randomized controlled trial design with follow-up at pre-test, post-test, and 4, 8 and 12 months) and process evaluation tools.

The primary study hypothesis is that participation in the Fourth R Healthy Relationships Plus program will be associated with positive growth in treatment participants' psychological well-being from pre-test to 12-month follow-up, as compared to control participants. In secondary analyses, the study will explore if treatment participants report less substance use, peer violence, bullying and dating violence at 12-month follow-up than control participants. Since certain person-level (e.g., sex, personality, executive functioning) and program-level (e.g., implementation quality) variables may moderate treatment-outcome relationships, these associations will also be explored. The final hypothesis is that treatment participants will report better attitudes, knowledge and assertive communication at post-test compared to control participants, and that these improvements will mediate the association between program participation and 12-month outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

Inclusion Criteria:

• Currently enrolled (as of March 2014) in grade 9 or 10 at schools serving as study sites

Exclusion Criteria:

• Not available during the period July 7-17, 2014 (the main study period)

• Not interested in participating in the project, as assessed on study information form

• Identified by the Guidance Office at his/her school as posing a serious safety risk to him/herself or others

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• Healthy Relationships Plus Program (HRPP)
The Healthy Relationships Plus Program (HRPP) is an out-of-school time program that is facilitated by a teacher or other youth leader. HRPP sessions use interactive teaching strategies to discuss healthy relationships, dating violence, personal values/boundaries, communication skills, emotional health and well-being, and helping friends.
• Control Condition (Classroom Activities)

Locations

Country	Name	City	State
Canada	CAMH Centre for Prevention Science	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	CAMH Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Chiodo D, Crooks CV, Wolfe DA, McIsaac C, Hughes R, Jaffe PG. Longitudinal prediction and concurrent functioning of adolescent girls demonstrating various profiles of dating violence and victimization. Prev Sci. 2012 Aug;13(4):350-9. doi: 10.1007/s11121-011-0236-3. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Growth from baseline to 12-month follow-up on psychological well-being in male vs. female participants	We plan subgroup analyses by sex to investigate if males' and females' psychological well-being differs over follow-up period. We have no a priori assumptions about sex differences.	Baseline, Month 4, Month 8, Month 12
Primary	Growth from baseline to 12-month follow-up on a multi-variable latent psychological well-being construct	Scales included to indicate the latent psychological well-being construct are: hope; purpose; depression/anxiety; emotion regulation; coping behaviours; flourishing mental health	Baseline, Month 4, Month 8, Month 12
Secondary	Decrease in reported perpetration on the Conflict in Adolescent Dating Relationships Inventory (CADRI) Physical Abuse and Threatening Behaviour sub-scales in treatment versus control participants at 12 month follow-up, compared to baseline		Baseline, Month 12
Secondary	Decrease in reported perpetration on the Cyber Dating Abuse scale in treatment versus control participants at 12 month follow-up, compared to baseline		Baseline, Month 12
Secondary	Decrease in reported physical fighting in treatment versus control participants at 12 month follow-up, compared to baseline		Baseline, Month 12
Secondary	Decrease in past 30 day drinking frequency in treatment versus control participants at 12 month follow-up, compared to baseline		Baseline, Month 12
Secondary	Decrease in past 30 day heavy episodic drinking (binge drinking) in treatment versus control participants at 12 month follow-up, compared to baseline		Baseline, Month 12
Secondary	Decrease in past 30 day marijuana use in treatment versus control participants at 12 month follow-up, compared to baseline		Baseline, Month 12
Secondary	Decrease in reported likelihood to try illicit drugs (e.g., marijuana; other illegal drugs; non-prescribed prescription drugs) during the next 12 months in treatment versus control participants at 12 month follow-up, compared to baseline		Baseline, Month 12
Secondary	Decrease in reported perpetration on the Bullying Evaluation and Strategies Tool (grade 7-12 items) in treatment versus control participants at 12 month follow-up, compared to baseline		Baseline, Month 12
Secondary	Decrease in hostility on a 4-point hostility scale in treatment versus control participants at 10 days, compared to baseline		Baseline, Day 10
Secondary	Improvement in drug attitudes on the 4-point Drug Attitude Scale in treatment versus control participants at 10 days, compared to baseline		Baseline, Day 10
Secondary	Improvement in attitudes towards violence on the 4-point Acceptability of Violence scale in treatment versus control participants at 10 days, compared to baseline		Baseline, Day 10
Secondary	Greater use of program concepts in written responses to 3 open-ended knowledge questions in treatment versus control participants at 10 days.		Day 10
Secondary	Improvement in interpersonal negotiation strategy scores with parents in treatment versus control participants at 10 days, compared to baseline		Baseline, Day 10
Secondary	Improvement in interpersonal negotiation strategy scores with peers in treatment versus control participants at 10 days, compared to baseline		Baseline, Day 10
Secondary	Improvement in interpersonal negotiation strategy scores with romantic partners in treatment versus control participants at 10 days, compared to baseline		Baseline, Day 10

External Links

•   CAMH Centre for Prevention Science and Fourth R homepage
•   Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto.