Clinical trial NCT06232733: HELP (HEalthy Lifestyles Project) for Youth With Mental Distress
Official title: HELP (HEalthy Lifestyles Project) for Youth With Mental Distress E-Health Intervention: Patient and Healthcare Impacts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: adolescent
healthy lifestyle behavior
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Children's Hospital Academic Medical Organization (CHAMO)
First posted: 2024-01-31
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Immediate or delayed intervention
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Strengths and Difficulties Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Habitual Activity Estimation Scale
timeFrame: 6 months
measure: Adolescent Sleep Hygiene Scale
timeFrame: 6 months
measure: Adolescent Sedentary Activity Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Clare Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: