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Digital Single Session Intervention for Youth Mental Health

N/A

Recruiting

Led By Katherine Venturo-Conerly, A.B.

Research Sponsored by Harvard University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

Awards & highlights

Study Summary

This trial will test if a one-time, digital intervention teaching the principle of practicing the opposite will help youths on the waitlist for psychotherapy.

Who is the study for?

This trial is for English-speaking youths aged 9-17 in the Boston area who are on a waitlist for mental health care. They must have access to a digital device, be able to read English well enough to complete digital programs, and have consent from at least one guardian.Check my eligibility

What is being tested?

The study tests 'Practicing the Opposite' (PTO), a single-session digital intervention aimed at improving youth mental health against usual waitlist procedures. It's designed for those awaiting psychotherapy.See study design

What are the potential side effects?

Since this is a psychological educational intervention, traditional physical side effects are not applicable. However, participants may experience emotional discomfort or distress as they engage with the material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Behavior and Feelings Survey (Youth and Parent Versions)

Generalized Anxiety Disorder 7-item scale (GAD-7)

Patient Health Questionnaire 8-item scale (PHQ-8)

+1 more

Secondary outcome measures

Clinic Record Data

Ecological Momentary Assessment (EMA) Survey

Perceived Control Scale for Children

+2 more

Other outcome measures

Demographic Questionnaire

Feedback Questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual waitlist control groupExperimental Treatment1 Intervention

Usual waitlist procedures involve watchful waiting for a therapist to become available, sometimes complemented by periodic check-ins from the family with clinic administrators. After being removed from the waitlist and contacted to begin treatment, participants in both study conditions will receive treatment as usual in the clinic.

Group II: Practicing the Opposite (PTO) interventionExperimental Treatment1 Intervention

This 30-45 minutes Qualtrics-based, digital program uses stories, interactive activities, and engaging graphics to teach youths one core principle: by practicing the positive opposite of unhelpful behaviors (e.g., engaging with rather than avoiding feared stimuli), one can, over time, change their mood, thoughts, and actions. The intervention is comprised of four main sections: 1) An introduction to PTO; (2) Testimonials from young people who have been helped by PTO; (3) Learning how to Practice the Opposite through online activities. (4) Planning how to continue to Practice the Opposite in the participant's life. Of note, after being removed from the waitlist at the clinic and contacted to begin treatment, participants will still receive treatment as usual from the clinic.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Harvard UniversityLead Sponsor

229 Previous Clinical Trials

474,279 Total Patients Enrolled

26 Trials studying Depression

9,692 Patients Enrolled for Depression

Katherine Venturo-Conerly, A.B.Principal InvestigatorHarvard University

Media Library

Practicing the Opposite (PTO) Clinical Trial Eligibility Overview. Trial Name: NCT05449002 — N/A

Depression Research Study Groups: Practicing the Opposite (PTO) intervention, Usual waitlist control group

Depression Clinical Trial 2023: Practicing the Opposite (PTO) Highlights & Side Effects. Trial Name: NCT05449002 — N/A

Practicing the Opposite (PTO) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05449002 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available to participants in this research study?

"Attend to the information found on clinicaltrials.gov and you will discover that this experiment is actively recruiting participants. It was initially uploaded onto the platform on September 5th, 2022 and its details were most recently revised nine days later."

Answered by AI

Is it possible to join this experiment?

"For enrolment in this trial, subjects must suffer from anxiety and fall within the 9-17 age range. This initiative is currently recruiting 226 patients."

Answered by AI

Are applicants aged 50 and above eligible to take part in this clinical investigation?

"The age range for those who wish to be enrolled in this medical trial spans from 9 years old up to 17."

Answered by AI

What end objective are the researchers aiming to achieve with this trial?

"This medical study will measure the primary outcome, Generalized Anxiety Disorder 7-item scale (GAD-7), by comparing changes in scores between intervention and control groups from baseline to post-intervention, 2 week follow ups and monthly check ins until either treatment completion or 1 year. Secondary outcomes include Ecological Momentary Assessment Survey which assesses youth affect/behaviour via self report; Perceived Control Scale for Children which evaluates beliefs about ability to change environment; Secondary Control Scale for Children that gauges sense of being able to regulate emotions/thoughts."

Answered by AI

How many volunteers are being invited to participate in this clinical study?

"Indeed, the information posted on clinicaltrials.gov states that this trial is actively seeking participants. This research was first publicized on September 5th 2022 and has since been updated as of September 9th. As of now 226 patients must be enrolled at a single center for the study to proceed."

Answered by AI