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

• ClinicalTrials.gov Identifier: NCT05962879
• Recruitment Status: Not yet recruiting
• First Posted: July 27, 2023
• Last Update Posted: July 27, 2023
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Nicole DeTore, PhD, Massachusetts General Hospital

Tracking Information

• First Submitted Date: July 17, 2023
• First Posted Date: July 27, 2023
• Last Update Posted Date: July 27, 2023
• Estimated Study Start Date: August 1, 2023
• Estimated Primary Completion Date: July 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 24, 2023)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

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

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.

Study Arms

• Experimental: Resilience Training for Teens
  A brief 6-session group-based behavioral intervention for teens at risk of a mental illness.
  Intervention: Behavioral: Resilience Training for Teens
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 24, 2023): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2027
• Estimated Primary Completion Date: July 31, 2027 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05962879
• Other Study ID Numbers: 2023P000985
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Nicole DeTore, PhD, Massachusetts General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Massachusetts General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Massachusetts General Hospital
• Verification Date: July 2023