NCT02140099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

May 13, 2014

Last Update Submit

August 5, 2019

Conditions

Mental Health Wellness 1

Keywords

Mental healthViolenceSubstance useAdolescentPrevention

Outcome Measures

Primary Outcomes (1)

  • 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: 1. hope 2. purpose 3. depression/anxiety 4. emotion regulation 5. coping behaviours 6. flourishing mental health

    Baseline, Month 4, Month 8, Month 12

Secondary Outcomes (15)

  • 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

  • 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

  • Decrease in reported physical fighting in treatment versus control participants at 12 month follow-up, compared to baseline

    Baseline, Month 12

  • Decrease in past 30 day drinking frequency in treatment versus control participants at 12 month follow-up, compared to baseline

    Baseline, Month 12

  • 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

  • +10 more secondary outcomes

Other Outcomes (1)

  • Growth from baseline to 12-month follow-up on psychological well-being in male vs. female participants

    Baseline, Month 4, Month 8, Month 12

Study Arms (2)

Healthy Relationships Education/Skills

EXPERIMENTAL

The experimental intervention is the group-based, 15-session Healthy Relationships Plus Program (HRPP). In this study, the HRPP will be offered in a condensed 8-day format (July 8-11 and 14-17, 2014). On days 1 to 7, participants will attend the program for 2 hours, and on day 8, participants will attend the program for 1 hour. The program will be facilitated by high school teachers. Eight HRPP groups will run concurrently during the study period.

Behavioral: Healthy Relationships Plus Program (HRPP)

Classroom Activities

OTHER

The control condition is a group-based, 15-session program focusing on typical Classroom Activities. The primary activity is to create a school welcome packet for incoming Grade 9 students, with other activities including reading and physical exercise. The control condition will be offered on 8 consecutive weekdays (July 8-11 and 14-17, 2014). On days 1 to 7, participants will attend the control program for 2 hours, and on day 8, participants will attend the control program for 1 hour. The control group will be facilitated by bachelor's level research assistants and pre-service teachers. Eight control groups will run concurrently during the study period.

Behavioral: Control Condition (Classroom Activities)

Interventions

Healthy Relationships Plus Program (HRPP)BEHAVIORAL

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.

Healthy Relationships Education/Skills
Control Condition (Classroom Activities)BEHAVIORAL
Classroom Activities

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAMH Centre for Prevention Science

London, Ontario, N6G4X8, Canada

Location

Related 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.

    PMID: 21769657BACKGROUND

  • 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.

    PMID: 22057307BACKGROUND

  • 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.

    PMID: 21652072BACKGROUND

  • 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.

    PMID: 19652099BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-BeingSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • David A Wolfe, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 16, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)