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HELP (HEalthy Lifestyles Project) for Youth With Mental Distress

Study acronym: HELP
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing
    • Site details revised
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 15, 2024 to Jun 15, 2024
    • Collaborators: 2 to 1
    v3
  4. Eligibility criteria shortened, about 65 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description expanded, about 10 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06232733
Lead Sponsor Children's Hospital of Eastern Ontario
Collaborators: Children's Hospital Academic Medical Organization (CHAMO)
Conditions
(from sponsor)		 Mental Health Issue
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov