Evaluation of the Healthy Relationships Plus Program for Youth

August 5, 2019 updated by: David Wolfe, PhD, Centre for Addiction and Mental Health

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6G4X8
        • CAMH Centre for Prevention Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Relationships Education/Skills
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.
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.
Other: Classroom Activities
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth from baseline to 12-month follow-up on a multi-variable latent psychological well-being construct
Time Frame: Baseline, Month 4, Month 8, Month 12

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 Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Baseline, Month 12
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
Time Frame: Baseline, Month 12
Baseline, Month 12
Decrease in reported physical fighting in treatment versus control participants at 12 month follow-up, compared to baseline
Time Frame: Baseline, Month 12
Baseline, Month 12
Decrease in past 30 day drinking frequency in treatment versus control participants at 12 month follow-up, compared to baseline
Time Frame: Baseline, Month 12
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
Time Frame: Baseline, Month 12
Baseline, Month 12
Decrease in past 30 day marijuana use in treatment versus control participants at 12 month follow-up, compared to baseline
Time Frame: Baseline, Month 12
Baseline, Month 12
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
Time Frame: Baseline, Month 12
Baseline, Month 12
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
Time Frame: Baseline, Month 12
Baseline, Month 12
Decrease in hostility on a 4-point hostility scale in treatment versus control participants at 10 days, compared to baseline
Time Frame: Baseline, Day 10
Baseline, Day 10
Improvement in drug attitudes on the 4-point Drug Attitude Scale in treatment versus control participants at 10 days, compared to baseline
Time Frame: Baseline, Day 10
Baseline, Day 10
Improvement in attitudes towards violence on the 4-point Acceptability of Violence scale in treatment versus control participants at 10 days, compared to baseline
Time Frame: Baseline, Day 10
Baseline, Day 10
Greater use of program concepts in written responses to 3 open-ended knowledge questions in treatment versus control participants at 10 days.
Time Frame: Day 10
Day 10
Improvement in interpersonal negotiation strategy scores with parents in treatment versus control participants at 10 days, compared to baseline
Time Frame: Baseline, Day 10
Baseline, Day 10
Improvement in interpersonal negotiation strategy scores with peers in treatment versus control participants at 10 days, compared to baseline
Time Frame: Baseline, Day 10
Baseline, Day 10
Improvement in interpersonal negotiation strategy scores with romantic partners in treatment versus control participants at 10 days, compared to baseline
Time Frame: Baseline, Day 10
Baseline, Day 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth from baseline to 12-month follow-up on psychological well-being in male vs. female participants
Time Frame: Baseline, Month 4, Month 8, Month 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: David A Wolfe, PhD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 146/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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