HELP (HEalthy Lifestyles Project) for Youth With Mental Distress

NCT ID: NCT06232733

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2028-12-31

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.

Conditions

Mental Health Issue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate Intervention

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

Group Type: EXPERIMENTAL

Healthy Lifestyles Project e-intervention

Intervention Type: BEHAVIORAL

Virtual lifestyle behaviour change support.

Delayed Intervention

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

Group Type: ACTIVE_COMPARATOR

Healthy Lifestyles Project e-intervention

Intervention Type: BEHAVIORAL

Virtual lifestyle behaviour change support.

Interventions

Healthy Lifestyles Project e-intervention

Virtual lifestyle behaviour change support.

Intervention Type: BEHAVIORAL

Other Intervention Names

HELP

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Academic Medical Organization (CHAMO)

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Dr. Pat Longmuir

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clare Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Research Coordinator

Role: CONTACT

cheoactive@cheo.on.ca

6137383908

Facility Contacts

Pat Longmuir, PhD

Role: primary

plongmuir@cheo.on.ca

6137383908

Other Identifiers

24

Identifier Type: -

Identifier Source: org_study_id