HELP (HEalthy Lifestyles Project) for Youth With Mental Distress (HELP)

February 9, 2024 updated by: Dr. Pat Longmuir, Children's Hospital of Eastern Ontario

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Intervention
Access to HELP e-intervention from 0 to 6 months with kinesiology support.
Behavioral: Healthy Lifestyles Project e-intervention
Virtual lifestyle behaviour change support.
Other Names:
  • HELP
Active Comparator: Delayed Intervention
Access to HELP e-intervention from 6 to 12 months with kinesiology support.
Behavioral: Healthy Lifestyles Project e-intervention
Virtual lifestyle behaviour change support.
Other Names:
  • HELP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strengths and Difficulties Questionnaire
Time Frame: 6 months
Youth emotional distress. Minimum score 0. Maximum Score 50. Higher score is lower emotional health.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Habitual Activity Estimation Scale
Time Frame: 6 months
Self-reported daily physical activity. Minutes and proportion of day spent inactive, somewhat inactive, somewhat active and active for weekend and week days.
6 months
Adolescent Sleep Hygiene Scale
Time Frame: 6 months
Self-reported sleep habits. Minimum score 33. Maximum score 198. Higher score is better sleep hygiene.
6 months
Adolescent Sedentary Activity Questionnaire
Time Frame: 6 months
Self-reported screen time (hours and minutes).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Eastern Ontario

Collaborators

The Physicians' Services Incorporated Foundation
Children's Hospital Academic Medical Organization (CHAMO)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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