Mental Health Wellness 1NCT02140099
Evaluation of the Healthy Relationships Plus Program for Youth
A study testing Healthy Relationships Plus Program (HRPP) in people with Mental Health Wellness 1, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Healthy Relationships Plus Program (HRPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Currently enrolled (as of March 2014) in grade 9 or 10 at schools serving as study sites
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Healthy Relationships Plus Program (HRPP), Control Condition (Classroom Activities)
- Keywords
- Mental health, Violence, Substance use, Adolescent, Prevention
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Relationships Plus Program (HRPP)Behavioural
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)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control Condition (Classroom Activities) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline, Month 12
Decrease in reported physical fighting in treatment versus control participants at 12 month follow-up, compared to baseline
Measured: Baseline, Month 12
Decrease in past 30 day drinking frequency in treatment versus control participants at 12 month follow-up, compared to baseline
Measured: 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
Measured: Baseline, Month 12
Decrease in past 30 day marijuana use in treatment versus control participants at 12 month follow-up, compared to baseline
Measured: 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
Measured: 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
Measured: Baseline, Month 12
Decrease in hostility on a 4-point hostility scale in treatment versus control participants at 10 days, compared to baseline
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 10
Improvement in interpersonal negotiation strategy scores with parents in treatment versus control participants at 10 days, compared to baseline
Measured: Baseline, Day 10
Improvement in interpersonal negotiation strategy scores with peers in treatment versus control participants at 10 days, compared to baseline
Measured: Baseline, Day 10
Improvement in interpersonal negotiation strategy scores with romantic partners in treatment versus control participants at 10 days, compared to baseline
Measured: Baseline, Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- CAMH Foundation
- Responsible party
- Principal investigator, David Wolfe, PhD, Centre for Addiction and Mental Health
- Investigators
- David A Wolfe, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140099
- Sponsor's protocol ID
- 146/2013
- Status last verified
- Aug 2019
- First submitted
- 13 May 2014
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21769657Wolfe 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.
PubMed 22057307Crooks 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.
PubMed 21652072Wolfe 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.
PubMed 19652099
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Healthy Relationships Plus Program for Youth
- ClinicalTrials.gov ID
- NCT02140099
- Acronym / sponsor ID
- 146/2013
- Conditions
- Mental Health Wellness 1
- Keywords
- Mental health, Violence, Substance use, Adolescent, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- CAMH Foundation
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Relationships Education/Skills | Experimental | Behavioral: Healthy Relationships Plus Program (HRPP)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. |
| Classroom Activities | Other | Behavioral: Control Condition (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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Currently enrolled (as of March 2014) in grade 9 or 10 at schools serving as study sites
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Healthy Relationships Education/Skills |
| Control Condition (Classroom Activities) | Behavioural | Classroom Activities |
Primary outcome
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
15 secondary outcomes
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
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
Decrease in reported physical fighting in treatment versus control participants at 12 month follow-up, compared to baseline
Time frame: 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
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
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
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
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
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
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
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
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
Improvement in interpersonal negotiation strategy scores with parents in treatment versus control participants at 10 days, compared to baseline
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 21769657Chiodo 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.
- Background: PubMed 22057307Wolfe 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.
- Background: PubMed 21652072Crooks 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.
- Background: PubMed 19652099Wolfe 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.
- 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.Link provided by the sponsor.
- CAMH Centre for Prevention Science and Fourth R homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Wolfe, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Relationships Plus Program (HRPP) in people with Mental Health Wellness 1, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140099, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.