NCT06232733

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jun 2024Dec 2028

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

January 22, 2024

Last Update Submit

March 16, 2026

Conditions

Mental Health Issue

Keywords

adolescenthealthy lifestyle behavior

Outcome Measures

Primary Outcomes (1)

  • Strengths and Difficulties Questionnaire

    Youth emotional distress. Minimum score 0. Maximum Score 50. Higher score is lower emotional health.

    6 months

Secondary Outcomes (3)

  • Habitual Activity Estimation Scale

    6 months

  • Adolescent Sleep Hygiene Scale

    6 months

  • Adolescent Sedentary Activity Questionnaire

    6 months

Study Arms (2)

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

Healthy Lifestyles Project e-interventionBEHAVIORAL

Virtual lifestyle behaviour change support.

Also known as: HELP
Delayed InterventionImmediate Intervention

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41183018DERIVED

Study Officials

  • Clare Gray, MD

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

6137383908cheoactive@cheo.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is not possible to blind the participants or families to the study group allocation. Investigators will support delivery of the intervention.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Immediate or delayed intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

June 15, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

CA(1)