Mental Health IssueHELPNCT06232733
HELP (HEalthy Lifestyles Project) for Youth With Mental Distress
A study testing Healthy Lifestyles Project e-intervention in people with Mental Health Issue, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Healthy Lifestyles Project e-intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Healthy Lifestyles Project e-intervention
- Keywords
- adolescent, healthy lifestyle behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyles Project e-interventionBehavioural
Also called HELP
Virtual lifestyle behaviour change support.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Access to HELP e-intervention from 0 to 6 months with kinesiology support. Receives: Behavioral: Healthy Lifestyles Project e-intervention |
| Delayed Intervention | Active comparator | Access to HELP e-intervention from 6 to 12 months with kinesiology support. Receives: Behavioral: Healthy Lifestyles Project e-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Difficulties Questionnaire
Youth emotional distress. Minimum score 0. Maximum Score 50. Higher score is lower emotional health.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
Adolescent Sleep Hygiene Scale
Self-reported sleep habits. Minimum score 33. Maximum score 198. Higher score is better sleep hygiene.
Measured: 6 months
Adolescent Sedentary Activity Questionnaire
Self-reported screen time (hours and minutes).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start15 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Immediate or delayed intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Academic Medical Organization (CHAMO)
- Responsible party
- Principal investigator, Dr. Pat Longmuir, Children's Hospital of Eastern Ontario
- Investigators
- Clare Gray, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232733
- Sponsor's protocol ID
- 24
- Acronym
- HELP
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41183018
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HELP (HEalthy Lifestyles Project) for Youth With Mental Distress E-Health Intervention: Patient and Healthcare Impacts
- ClinicalTrials.gov ID
- NCT06232733
- Acronym / sponsor ID
- HELP / 24
- Conditions
- Mental Health Issue
- Keywords
- adolescent, healthy lifestyle behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Children's Hospital Academic Medical Organization (CHAMO)
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Immediate or delayed intervention
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Healthy Lifestyles Project e-interventionAccess to HELP e-intervention from 0 to 6 months with kinesiology support. |
| Delayed Intervention | Active comparator | Behavioral: Healthy Lifestyles Project e-interventionAccess to HELP e-intervention from 6 to 12 months with kinesiology support. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Lifestyles Project e-interventionAlso: HELPVirtual lifestyle behaviour change support. | Behavioural | Delayed Intervention, Immediate Intervention |
Primary outcome
Strengths and Difficulties Questionnaire
Time frame: 6 months
Youth emotional distress. Minimum score 0. Maximum Score 50. Higher score is lower emotional health.
3 secondary outcomes
Habitual Activity Estimation Scale
Time frame: 6 months
Adolescent Sleep Hygiene Scale
Time frame: 6 months
Adolescent Sedentary Activity Questionnaire
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Derived from this study: PubMed 41183018Patel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Gray, MD principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyles Project e-intervention in people with Mental Health Issue, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.