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

Not Applicable

Recruiting

• Conditions: Depressive Disorder; Anxiety Disorders; Psychotic Disorders; Psychosocial Functioning
• Interventions: Behavioral: Resilience Training for Teens

• Registration Number: NCT05962879
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-07-27
• Study Start: 2024-03-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resilience Training for Teens	Resilience Training for Teens	A brief 6-session group-based behavioral intervention for teens at risk of a mental illness.

Primary Outcome Measures

Name	Time	Method
Structured Interview of Psychosis-risk Syndromes (SIPS)	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

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States