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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.
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 moreSecondary outcome measures
Clinic Record Data
Ecological Momentary Assessment (EMA) Survey
Perceived Control Scale for Children
+2 moreOther 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.
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Who is running the clinical trial?
Harvard UniversityLead Sponsor
230 Previous Clinical Trials
474,399 Total Patients Enrolled
26 Trials studying Depression
9,692 Patients Enrolled for Depression
Katherine Venturo-Conerly, A.B.Principal InvestigatorHarvard University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The child has a device that can access the internet.I am between 9 and 17 years old.I do not have a smartphone, computer, or tablet.I do not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Practicing the Opposite (PTO) intervention
- Group 2: Usual waitlist control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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