HELP (HEalthy Lifestyles Project) for Youth With Mental D... | NCT06232733

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

NCT06232733

Sponsor

Children's Hospital of Eastern Ontario

Status

Recruiting

Last Update Posted

Mar 17, 2026Actual

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Mental Health Issue

Interventions

Healthy Lifestyles Project e-intervention

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2024Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Jan 22, 2024

First Submission Date that Met QC Criteria

Jan 22, 2024

First Posted Date

Jan 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Pat Longmuir, Senior Scientist, Children's Hospital of Eastern OntarioPrincipal Investigator

Lead Sponsor

Children's Hospital of Eastern OntarioOTHER

Collaborators

Name	Class
Children's Hospital Academic Medical Organization (CHAMO)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate Intervention	Experimental	Access to HELP e-intervention from 0 to 6 months with kinesiology support.	Behavioral: Healthy Lifestyles Project e-intervention
Delayed Intervention	Active Comparator	Access to HELP e-intervention from 6 to 12 months with kinesiology support.	Behavioral: Healthy Lifestyles Project e-intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Healthy Lifestyles Project e-intervention	Behavioral	Virtual lifestyle behaviour change support.	Delayed Intervention Immediate Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Habitual Activity Estimation Scale	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Research Coordinator	Contact	6137383908		cheoactive@cheo.on.ca

Overall Officials

Name	Affiliation	Role
Clare Gray, MD	Children's Hospital of Eastern Ontario	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Eastern Ontario	Recruiting	Ottawa	Ontario	K1H 8L1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41183018	Derived	Patel R, Longmuir PE, Robb M, Baechler N, Courtney K, Norris M, Goldfield G, Cooligan F, Watson S, Cloutier P, Gray C. Evaluation of the novel HEalthy Lifestyle Project (HELP) youth mental health e-intervention for lifestyle behaviour change and mental healthcare system impact: A randomized controlled trial protocol. PLoS One. 2025 Nov 3;20(11):e0332363. doi: 10.1371/journal.pone.0332363. eCollection 2025.