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Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05962879
Recruitment Status : Not yet recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Nicole DeTore, PhD, Massachusetts General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Psychotic Disorders Depressive Disorder Psychosocial Functioning Behavioral: Resilience Training for Teens Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : July 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Resilience Training for Teens
A brief 6-session group-based behavioral intervention for teens at risk of a mental illness.
 Behavioral: Resilience Training for Teens
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05962879


Contacts
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Contact: Nicole R DeTore, PhD 617-726-2065 ndetore@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
More Information
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Responsible Party: Nicole DeTore, PhD, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT05962879    
Other Study ID Numbers: 2023P000985
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Anxiety Disorders
Mental Disorders
 Psychotic Disorders
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders