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Completed

NCT Number: NCT02140099

Evaluation of the Healthy Relationships Plus Program for Youth

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.

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAMH Centre for Prevention Science

London, Ontario, N6G4X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control Condition (Classroom Activities)

Behavioral

Primary outcomes

  1. 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:

    • hope
    • purpose
    • depression/anxiety
    • emotion regulation
    • coping behaviours
    • flourishing mental health

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: Baseline, Month 12

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  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

  11. 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

  12. 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

  13. Improvement in interpersonal negotiation strategy scores with parents in treatment versus control participants at 10 days, compared to baseline

    Time frame: Baseline, Day 10

  14. Improvement in interpersonal negotiation strategy scores with peers in treatment versus control participants at 10 days, compared to baseline

    Time frame: Baseline, Day 10

  15. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • CAMH Foundation

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 16, 2014
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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