HELP (HEalthy Lifestyles Project) for Youth With Mental Distress

Children's Hospital of Eastern Ontario

Status: Enrolling

Conditions: Mental Health Issue

Treatments: Behavioral: Healthy Lifestyles Project e-intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06232733

24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Immediate Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Healthy Lifestyles Project e-intervention

Delayed Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Healthy Lifestyles Project e-intervention