Healthy Lifestyles Project for Youth With Mental Distress
HELP (HEalthy Lifestyles Project) for Youth With Mental Distress E-Health Intervention: Patient and Healthcare Impacts
This study is testing a 6-month online program to see if it can help young people aged 12 to 17 improve their mental health and lifestyle by focusing on exercise, sleep, and screen time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Eastern Ontario Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06232733 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a 6-month e-intervention designed to support the mental health of youth aged 12 to 17. Participants will engage in the HELP e-intervention, which includes resources on physical activity, sleep, and screen time, with support from a kinesiologist. The study will compare emotional health and lifestyle behavior improvements between those receiving the intervention immediately and those who will receive it after a 6-month delay. Assessments will be conducted at multiple time points to measure changes in emotional health and healthcare resource utilization.
Who should consider this trial
Good fit: Ideal candidates are youth aged 12-17 who are seeking or receiving support for emotional distress.
Not a fit: Patients with identified or suspected eating disorders or those deemed inappropriate for the study by their clinician may not benefit.
Why it matters
Potential benefit: If successful, this intervention could significantly improve emotional health and lifestyle behaviors in adolescents experiencing mental distress.
How similar studies have performed: Other studies have shown promise in using e-interventions for mental health support, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Youth 12-17 years of age seeking, waiting for or receiving support for emotional distress. * Able to provide informed consent to study participation. * Able to engage in the HELP e-intervention in English (French translation of the e-modules will not be available until intervention efficacy is established). * Willing to be randomized to a study group. * Willing to complete objective behaviour measures if selected (1 of 3 participants). * Willing to complete the study questionnaires. * Willing to provide consent for evaluation of mental healthcare system outcomes via their health record. Exclusion Criteria: * Identified or suspected eating disorder * Youth whose health or family status is deemed to be inappropriate for the study as per their most responsible clinician.
Where this trial is running
Ottawa, Ontario
- Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Clare Gray, MD — Children's Hospital of Eastern Ontario
- Study coordinator: Research Coordinator
- Email: cheoactive@cheo.on.ca
- Phone: 6137383908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.