- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05962879
Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
June 3, 2026 updated by: Nicole DeTore, PhD, Massachusetts General Hospital
This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicole R DeTore, PhD
- Phone Number: 617-726-2065
- Email: ndetore@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Nicole R DeTore, PhD
- Email: ndetore@mgh.harvard.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Currently enrolled in 9th through 12th grade and between the ages of 14 and 19
- Endorsed at least one psychotic experience
- Provided contact information
- Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18)
- Have a parent or legal guardian who is able and willing to participate in a parent session
- Competent and willing to provide written informed assent (if under the age of 18) or consent (if age 18 or older)
- Able to communicate in English
Exclusion Criteria:
- Currently prescribed psychotropic medication (not including medications for attention deficit/hyperactivity disorder), regardless of adherence
- Currently obtaining psychotherapeutic intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resilience Training for Teens
A brief 6-session group-based behavioral intervention for teens at risk of a mental illness.
|
A brief 6-session group-based behavioral intervention for high school aged teenagers at risk of a mental illness.
|
|
No Intervention: Waitlist
A one year waitlist period where participants will not participate in Resilience Training for Teens.
Following that one year waitlist period, they can participate in Resilience Training for Teens.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Structured Interview of Psychosis-risk Syndromes (SIPS)
Time Frame: 1 year
|
Subclinical psychotic symptoms that represent a risk of transdiagnostic mental illnesses.
This semi-structured interview rates psychotic experiences, general symptoms, and functioning.
The SIPS interview assesses positive, negative, disorganized, and general symptoms.
The range of the Scale of Psychosis-risk Symptoms (SOPS) is 0-6, with a higher score representing more severe symptoms.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Behavior Checklist (CBCL)
Time Frame: 1 year
|
Mental health symptoms in the teen rated by both the teen and the parent/guardian consisting of 113 items.
The CBCL rates multiple domains across functioning and psychiatric diagnoses.
It is scored on a 3-point Likert scale, with higher scores representing more severe symptoms.
|
1 year
|
|
Global Functioning Social and Role Scales
Time Frame: 1 year
|
Social and school/work functioning captured on this scale rated on a 10 point likert scale assessing functional and social functioning separately.
Higher ratings represent richer functioning.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
July 17, 2023
First Submitted That Met QC Criteria
July 24, 2023
First Posted (Actual)
July 27, 2023
Study Record Updates
Last Update Posted (Actual)
June 5, 2026
Last Update Submitted That Met QC Criteria
June 3, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P000985
- K23MH131793 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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