Inclusion criteria.

Study participants will meet the following criteria:

1. a). Be 12–17 years of age;
2. b). Self-identify as experiencing emotional distress regardless of whether they are seeking, waiting for, or receiving support for emotional distress;
3. c). Able to provide informed consent to study participation;
4. d). Willing to be randomized to a study group;
5. e). Willing to complete objective behaviour measures if selected (one of three participants); and
6. f). Willing to provide consent for evaluation of mental healthcare system outcomes via their health record.

Study participants will be able to self-refer in response to public information about the study or can be referred by the care provider or community organization that they contact for support.

Exclusion criteria.

1. a). Unable or unwilling to complete questionnaires in English or French;
2. b). Unable or unwilling to use HELP in English (resources not yet translated);
3. c). Identified or suspected to have an eating disorder; these youth often have a compulsive exercise co-morbidity that may be negatively impacted by the physical activity promoting components within HELP; and
4. d). Health or family status deemed to be inappropriate for the study as per their most responsible clinician.

Recruitment.

1Call1Click is the centralized intake portal for all youth mental health services in the region. A best practice advisory flag has been implemented within the electronic health record system to identify potential study participants for intake staff. Intake staff will be educated on a standardized initial study screening process, including inclusion/exclusion criteria and consent. With permission, mental health clinicians can also refer youth for enrollment. Additional distribution of study material will be done via posters and social media posts in patient areas and through partner groups.

Consent.

The research coordinator will explain the study in full to the potential participant, who will then be given the opportunity to have all of their questions answered. If they agree to participate and meet the eligibility criteria, the researcher will obtain their consent to participate. Participants will choose the format to provide consent from three options: electronic (digital consent document, independent review of consent, archive and participant copy), verbal (phone or electronic connection, verbal review of consent, researcher records responses), or paper (review of consent with researcher, hard copy signature). Regardless of format, the researcher will review the study details, answer participants’ questions, confirm their identity, and ensure a copy of the completed consent form is provided to the participant.

Safety considerations.

There are no medical or health risks associated with participating in this study and participants will not be required to make any changes to their health services, supports, medications, or other treatments. Discomfort may occur when patients are answering questions about lifestyle behaviours that they think will be viewed negatively. The research coordinator will reassure participants that questions are asked only to compare to previous timepoints.

In cases where participation is triggering for a patient, the research coordinator will immediately notify the leading psychiatrist (CG) who will coordinate a clinical follow up as necessary. If a participant gives any indication that there is an increased risk of harm (suicidal ideation, self-harm, harm to others), the patient’s most responsible clinician will be contacted. Participants will be made aware of the limitations of confidentiality during the consent process.

Study design.

The study is a single-arm crossover randomized controlled trial. Youth will participate in the study for 12 months. Participants will be randomized (1:1 without stratification) to have access to the HELP e-intervention either immediately (between zero and six months) or after a delay of six months (between six and 12 months). This study design enables us to evaluate the impact of a delay in access to the intervention, to see how youth would progress with and without HELP access. The delayed intervention design also alleviates ethical concerns that would arise if some enrolled youth never had access to the study intervention. All participants will continue with standard care throughout the study. The 6-month intervention timeframe was chosen to expand on the pilot study which provided small but important benefits after only three months of intervention access. All study activities will be conducted remotely via digital surveys or mailed paper questionnaires. Completion of each questionnaire will require approximately one hour, working collaboratively with the research coordinator. In the pilot study, researcher support was needed to encourage engagement and questionnaire completion. The extent of this support will be tracked. All study measures will be administered by a researcher who is blind to group allocation. Outcomes will be assessed four times: at zero, three, six, and 12 months after enrollment.

Study outcomes.

The primary intervention efficacy outcome is youth emotional well-being as measured by the total scores of the full scale Strengths and Difficulties Questionnaire [12]. This instrument was selected because our target population is all youth experiencing mental distress, including those with relational or conduct problems. The HELP intervention does not target specific aspects of mental health, aligning with the broad screening aspect of the Strengths and Difficulties Questionnaire. A clinically significant improvement is defined as a score decrease of 15%, with the reduction occurring after participants have engaged with the intervention. This change is just under half of the Strengths and Difficulties Questionnaire improvement observed after six months of specialist community mental health services [13]. Emotional well-being is being used as an outcome as per the primary hypothesis correlating lifestyle behaviour change with improved mental health, as reflected in emotional wellbeing.

Secondary outcomes are measures of lifestyle choices (Youth Quality of Life-short form [14]), readiness for behaviour change (Stages of Change Questionnaire [15]), sleep hygiene (Adolescent Sleep Hygiene Scale [16]), daily physical activity (Habitual Activity Estimation Scale [17]), and leisure screen time (Adolescent Sedentary Activity Questionnaire [18]). Behaviour change theory emphasizes that individuals move through a series of stages, with the most effective intervention differing for each stage [19]. Achieving Stages 3–5 is required for behaviour change to occur (Stages 1 & 2 are moving toward the decision to change behaviour). HELP was developed to support youth in all stages of change [20].

A randomly selected sub-sample of participants (one in three enrolled) will wear a tri-axial accelerometer on a waist-worn belt for seven days after completing the questionnaires to objectively measure physical activity and sleep [21]. Sleep times, device removal times, and social media time will be recorded on a daily log sheet by these participants. In total, this additional data from ~40 participants will provide sufficient statistical power to evaluate the validity of the self-reported behavior data.

The healthcare system outcomes will be evaluated through youth mental healthcare system utilization. Whether HELP resource availability reduces mental health system visits or decreases the time that mental health specialists spend on lifestyle counselling will be assessed after study completion. These data will be collected from study enrollment for a period of 18 months. Quantitative measures include:

• Number of supports contacted;
• Types of support contacted (community provider, peer support, outpatient, day treatment, inpatient, etc.);
• Type of system contacts (request for support, appointment scheduling, treatment visit)
• Purpose of support (assessment, counselling, etc.);
• Type of mental distress;
• Professional seen (psychiatrist, psychologist, social worker, nurse, etc.); and
• Length of visit in minutes.

In addition, the complete text from each clinic visit note for each contact will be de-identified and retained in the study database for qualitative analyses to understand the lifestyle content and intent of documented discussions.

Sample size determination.

In the pilot study, youth engagement and full questionnaire completion was over 80% with assistance from a research coordinator. Since this trial will use the same supported method for questionnaire completion, the expected participation is that >80% of enrolled youth will have complete data. Complete data for 122 youth would provide 80% power to detect a 3.4-point difference in emotional health as measured by the Strengths and Difficulties Questionnaire total score. Based on the pilot data, a 3.4-point improvement in score would move the average score for study participants below the level of clinical concern and would be equivalent to the 19.5% improvement observed in the three-month pilot study. Given the pilot study data, the standardized effect size is hypothesized to be d = 0.5.

Gender and age-specific sampling will be extrapolated from the data depending on final recruitment demographics

Sex and gender.

Sex and gender are key factors in examining lifestyle needs as sleep, physical activity, and screen time are known to vary by these factors in adolescence [21–23]. Youth will be asked to self-report their gender identity and biological sex at birth; the impact of these factors will be examined in all analyses. Recruitment by sex and gender (boy, girl, non-binary, transgender) will be monitored and recruitment strategies will be adapted as needed. The Lived Experience Advisory Group includes gender diverse youth who have guided e-resource development and will continue to support the recruitment strategies they developed.

Participation timeline.

Study enrollment is planned from April 2025 to March 2026. Data collection continues for 1 year after study enrollment and is therefore expected to continue until March 2027, with results anticipated by the end of 2027. Refer to Fig 1 for details of the timeline for enrolled participants.

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Fig 1. SPIRIT diagram of participant research participation and data analysis timeline.

Fig 1 footnote: A-1,2,3,4: Assessments including questionnaires and additional accelerometry, sleep, screen time tracking for one in three youth. HA: HELP access including e-resource and kinesiologist support. HCR: Health Chart Review of patient records.

https://doi.org/10.1371/journal.pone.0332363.g001

Intervention.

Research coordinators will directly engage with enrolled youth two to three times per week until they can continue the intervention independently. The initial session will introduce the participant to the HELP e-intervention (S1–S4 File Supplementary Material), review their baseline assessment results and focus their planned activities in light of their readiness for behaviour change. Subsequent sessions with the research coordinator will be scheduled as required by each youth in order for them to engage with the HELP e-resources on a consistent basis. Once consistent, independent engagement is established, formal sessions with the research coordinator will occur only when requested by the youth, reinforcing their autonomy to successfully change their behaviour. The HELP e-intervention resources are presented in four sections: Know Your Habits, Sleep, Screen Time, and Physical Activity. Know Your Habits provides youth with an interpretation of their personal baseline questionnaire results. The interpretation provides feedback on their current sleep, screen time and physical activity behaviours and makes recommendations for use of the HELP e-resources based on their current habits and readiness for behaviour change. Access to all HELP modules is always available, but Know Your Habits suggests personalized avenues for change based on each participant’s assessment results.

The Sleep, Screen Time and Physical Activity behaviour sections each have four sub-sections (Learn, Pros and Cons, Goals, and Resources), designed to align with the precontemplation, contemplation, preparation and action stages of behaviour change [19]. Learn conveys information linking the lifestyle behaviour and mental health. This section targets youth not yet considering behaviour change. Pros and Cons supports youth to consider the barriers and facilitators of behaviour change. This section guides youth to address any ambivalence as they contemplate making a change. The Goals section enables youth to choose from over 70 change plans that each provide a step-by-step process for making a small change to current behaviour. Each plan has a sequence of six to eight self-guided steps that youth complete in order to achieve their behaviour change goal. Each step typically requires two to 30 minutes to complete over one or more days. Roadblock activities are available to support the maintenance of recent behaviour changes. Information is also provided for setting SMART (specific, measurable, achievable, realistic, timely) goals. Youth can track their goals and accomplishments on the website. Resources provides additional links to external resources as well as access to the study kinesiologist.

Each participant will have a unique login from which intervention use (site visits, interactivity use, knowledge component completion) will be automatically tracked. This engagement data will also assess the frequency or type of intervention use, which will be considered when analyzing the intervention’s impact on any observed behaviour changes.