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

Primary Purpose

Anxiety Disorders, Psychotic Disorders, Depressive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resilience Training for Teens
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorders

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Resilience Training for Teens

    Waitlist

    Arm Description

    A brief 6-session group-based behavioral intervention for teens at risk of a mental illness.

    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.

    Outcomes

    Primary Outcome Measures

    Structured Interview of Psychosis-risk Syndromes (SIPS)
    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

    Child Behavior Checklist (CBCL)
    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.
    Global Functioning Social and Role Scales
    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.

    Full Information

    First Posted
    July 17, 2023
    Last Updated
    July 24, 2023
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05962879
    Brief Title
    Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
    Official Title
    Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2027 (Anticipated)
    Study Completion Date
    July 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorders, Psychotic Disorders, Depressive Disorder, Psychosocial Functioning

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Resilience Training for Teens
    Arm Type
    Experimental
    Arm Description
    A brief 6-session group-based behavioral intervention for teens at risk of a mental illness.
    Arm Title
    Waitlist
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Resilience Training for Teens
    Intervention Description
    A brief 6-session group-based behavioral intervention for high school aged teenagers at risk of a mental illness.
    Primary Outcome Measure Information:
    Title
    Structured Interview of Psychosis-risk Syndromes (SIPS)
    Description
    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.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Child Behavior Checklist (CBCL)
    Description
    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.
    Time Frame
    1 year
    Title
    Global Functioning Social and Role Scales
    Description
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicole R DeTore, PhD
    Phone
    617-726-2065
    Email
    ndetore@mgh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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