Digital Single Session Intervention for Youth Mental Health (NCT05449002) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Digital Single Session Intervention for Youth Mental Health
United States226 participantsStarted 2022-09-05
Plain-language summary
The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.
Who can participate
Age range
9 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Youth/family has contacted a participating outpatient clinic to seek mental health care, and is placed on the waitlist.
* Youth is between the ages of 9-17 years (inclusive) at the time of study enrollment.
* Youth and at least one guardian consent to the youth's participation in study.
* Youth reads English well enough to effectively complete the digital programs (defined as taking classes in English, as opposed to ESL classes).
* Youth has access to a digital device.
Exclusion Criteria:
* Youth is non-English speaking, as the program is only available in English.
* Youth does not have access to a digital device.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a single digital session — so what is your honest view on whether a one-time online intervention is likely to be enough support for my child's level of anxiety, depression, or conduct issues, compared to ongoing therapy or other treatments?
2The study is no longer actively recruiting — does that mean my child could still potentially participate, or does it mean we should focus entirely on other options right now?
3Since this trial has no listed phase, it sounds more like a behavioral research study than a drug trial — can you help me understand what that means for how well the safety and effectiveness of this approach have been tested so far?
4The trial measures outcomes using tools like the GAD-7 and PHQ-8 — are those the same measures you'd use to track my child's progress in standard care, and how would we know if the intervention is actually helping?
5Given that this is a digital self-guided intervention, what are your concerns about my child doing this without regular check-ins from a clinician, especially if their symptoms are more severe or complex?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavior and Feelings Survey (Youth and Parent Versions)
Timeframe: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
2
Generalized Anxiety Disorder 7-item scale (GAD-7)
Timeframe: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
3
Patient Health Questionnaire 8-item scale (PHQ-8)
Timeframe: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
4
Revised Children's Anxiety and Depression Scale (RCADS) Parent Version (Short Form)
Timeframe: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.