跳至主要内容
临床试验/NCT06232733
NCT06232733进行中(未招募)不适用

HELP (HEalthy Lifestyles Project) for Youth With Mental Distress E-Health Intervention: Patient and Healthcare Impacts

Children's Hospital of Eastern Ontario2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
130
试验地点
2
主要终点
Strengths and Difficulties Questionnaire

研究概览

简要总结

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.

详细描述

This study will evaluate the efficacy of 6 months of HELP e-intervention access with kinesiologist support in a randomized controlled trial to determine if the changes in emotional health (primary outcome) and lifestyle behaviors (secondary outcomes) differ from changes among youth with delayed intervention access (control condition). Sustainability of the intervention will be assessed for an additional 6 months. Participants will be youth 12-17 years of age who contact youth mental health services. The unique HELP e-resources developed by the research team utilize age-appropriate graphics and interactive formats developed collaboratively with youth/parent/clinician partners. There are 4 sections: 1) Know Your Habits, 2) Physical Activity, 3) Screen Time, 4) Sleep. A kinesiologist will support participants in the intervention. Study assessments will be completed by researchers blind to study group allocation. Researchers will also evaluate the impact of the HELP e-intervention on the use of mental healthcare services, the need for mental health professional support of lifestyle behaviors and the association between self-reported and objectively measured lifestyle behaviors. It is hypothesized that youth engaging in the HELP e-intervention will have improved emotional health and enhanced lifestyle behaviors in comparison to those receiving the delayed (post 6-months) intervention. It is also hypothesized that changes during the intervention will be maintained for an additional 6 months, and that self-reported measures will accurately reflect objective measurements. Finally, it is hypothesized that youth engaging in the HELP e-intervention will require fewer youth mental health supports, and when supported will be less likely to require treatment directed at lifestyle behaviors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

It is not possible to blind the participants or families to the study group allocation. Investigators will support delivery of the intervention.

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Immediate Intervention

Experimental

Access to HELP e-intervention from 0 to 6 months with kinesiology support.

干预措施: Healthy Lifestyles Project e-intervention (Behavioral)

Delayed Intervention

Active Comparator

Access to HELP e-intervention from 6 to 12 months with kinesiology support.

干预措施: Healthy Lifestyles Project e-intervention (Behavioral)

结局指标

主要结局

Strengths and Difficulties Questionnaire

时间窗: 6 months

Youth emotional distress. Minimum score 0. Maximum Score 50. Higher score is lower emotional health.

次要结局

  • Habitual Activity Estimation Scale(6 months)
  • Adolescent Sleep Hygiene Scale(6 months)
  • Adolescent Sedentary Activity Questionnaire(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Pat Longmuir

Senior Scientist

Children's Hospital of Eastern Ontario

研究点 (2)

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