HELP (HEalthy Lifestyles Project) for Youth With Mental Distress

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorChildren's Hospital of Eastern Ontario

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • Healthy Lifestyles Project e-intervention

    Behavioral

    Virtual lifestyle behaviour change support.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Immediate InterventionExperimental treatment 1 intervention
Group B: Delayed InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Strengths and Difficulties Questionnaire

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

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

Adolescent Sleep Hygiene Scale

Self-reported sleep habits. Minimum score 33. Maximum score 198. Higher score is better sleep hygiene.

Time frame
6 months
3

Adolescent Sedentary Activity Questionnaire

Self-reported screen time (hours and minutes).

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Eastern Ontario

Lead sponsor

Children's Hospital Academic Medical Organization (CHAMO)

Collaborator