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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05962879
Collaborator
(none)
70
2
48

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Resilience Training for Teens
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2027
Anticipated Study Completion Date :
Jul 31, 2027

Arms and Interventions

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

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nicole DeTore, PhD, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05962879
Other Study ID Numbers:
  • 2023P000985
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023