NCT06232733 HELP (HEalthy Lifestyles Project) for Youth With Mental Distress
| NCT ID | NCT06232733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Eastern Ontario |
| Condition | Mental Health Issue |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-06-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2024-06-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn about how healthcare providers can support youths' mental health. The main question\[s\] it aims to answer are: * Do youth (12 to 17 years of age) who engage in the 6-month HELP e-intervention have a larger improvement in emotional health (measured by the Strengths and Difficulties Questionnaire) than youth who do not receive the intervention? * Does engagement in the HELP e-intervention improve lifestyle behaviour (physical activity, sleep or screen time)? * Do youth who engage in the 6-month HELP e-intervention utilize fewer mental healthcare resources, during and for 1 year following study participation, than youth who do not receive the intervention? Participants will receive the HELP intervention for 6 months, either immediately or after waiting 6 months from study enrollment. At 0, 3, 6, and 12 months, participants will answer a series of questionnaires to assess their emotional health and lifestyle behaviors. Researchers will compare the emotional health and lifestyle behaviors of youth who received HELP immediately to those who wait for 6 months prior to the intervention to see if their emotional health or lifestyle behaviors differ.
Eligibility 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.
Contact & Investigator
Clare Gray, MD
PRINCIPAL INVESTIGATOR
Children's Hospital of Eastern Ontario
Frequently Asked Questions
Who can join the NCT06232733 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Mental Health Issue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06232733 currently recruiting?
Yes, NCT06232733 is actively recruiting participants. Contact the research team at cheoactive@cheo.on.ca for enrollment information.
Where is the NCT06232733 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06232733 clinical trial?
NCT06232733 is sponsored by Children's Hospital of Eastern Ontario. The principal investigator is Clare Gray, MD at Children's Hospital of Eastern Ontario. The trial plans to enroll 130 participants.