Clinical trial NCT02140099: Evaluation of the Healthy Relationships Plus Program for Youth
Official title: Evaluation of the Healthy Relationships Plus Program for Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Mental health
Violence
Substance use
Adolescent
Prevention
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: CAMH Foundation
First posted: 2014-05-16
Enrollment: 238
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Growth from baseline to 12-month follow-up on a multi-variable latent psychological well-being construct
timeFrame: Baseline, Month 4, Month 8, Month 12
Secondary outcomes:
measure: 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
timeFrame: Baseline, Month 12
measure: Decrease in reported perpetration on the Cyber Dating Abuse scale in treatment versus control participants at 12 month follow-up, compared to baseline
timeFrame: Baseline, Month 12
measure: Decrease in reported physical fighting in treatment versus control participants at 12 month follow-up, compared to baseline
timeFrame: Baseline, Month 12
measure: Decrease in past 30 day drinking frequency in treatment versus control participants at 12 month follow-up, compared to baseline
timeFrame: Baseline, Month 12
measure: Decrease in past 30 day heavy episodic drinking (binge drinking) in treatment versus control participants at 12 month follow-up, compared to baseline
timeFrame: Baseline, Month 12
measure: Decrease in past 30 day marijuana use in treatment versus control participants at 12 month follow-up, compared to baseline
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: 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
timeFrame: Baseline, Month 12
measure: Decrease in hostility on a 4-point hostility scale in treatment versus control participants at 10 days, compared to baseline
timeFrame: Baseline, Day 10
measure: Improvement in drug attitudes on the 4-point Drug Attitude Scale in treatment versus control participants at 10 days, compared to baseline
timeFrame: Baseline, Day 10
measure: Improvement in attitudes towards violence on the 4-point Acceptability of Violence scale in treatment versus control participants at 10 days, compared to baseline
timeFrame: Baseline, Day 10
measure: Greater use of program concepts in written responses to 3 open-ended knowledge questions in treatment versus control participants at 10 days.
timeFrame: Day 10
measure: Improvement in interpersonal negotiation strategy scores with parents in treatment versus control participants at 10 days, compared to baseline
timeFrame: Baseline, Day 10
measure: Improvement in interpersonal negotiation strategy scores with peers in treatment versus control participants at 10 days, compared to baseline
timeFrame: Baseline, Day 10
measure: Improvement in interpersonal negotiation strategy scores with romantic partners in treatment versus control participants at 10 days, compared to baseline
timeFrame: Baseline, Day 10
Other outcomes:
measure: Growth from baseline to 12-month follow-up on psychological well-being in male vs. female participants
timeFrame: Baseline, Month 4, Month 8, Month 12
Locations:
city: London
country: Canada
facility: CAMH Centre for Prevention Science
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: David A Wolfe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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: 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.