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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962879
• Other study ID #: 2023P000985
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Nicole R DeTore, PhD
• Phone: 617-726-2065
• Email: ndetore[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder
• Mental Disorders
• Psychosocial Functioning
• Psychotic Disorders

Intervention

Behavioral:
• Resilience Training for Teens
A brief 6-session group-based behavioral intervention for high school aged teenagers at risk of a mental illness.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year