School-Based Living in Families with Emotions Training

Not Applicable

Completed

• Conditions: Living in Families with Emotions

• Registration Number: NCT06793878
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The overall purpose of this study is to identify adolescents who are at-risk for psychosis, as evidenced by endorsement of mild-to-moderate, sub-syndromal symptoms, and provide them with a potentially preventive intervention aimed at enhancing resilience.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-29
• Primary Completion: 2024-01-18
• Study Completion: 2024-07-20
• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male and female adolescents from the Boston area who are in middle school at the time of enrollment;
2. Enrolled in a school where study screening is taking place;
3. Have a parent or legal guardian who is able and willing to provide written informed consent;
4. Competent and willing to provide written informed assent;
5. English language proficiency of parent/guardian and participant;
6. Response of "yes, definitely" or "maybe" to auditory hallucinations, visual hallucinations, or paranoia on the Adult Psychotic-like Symptom Checker (APSS);
7. Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator.

Exclusion Criteria

1. Current DSM-V diagnosis with serious active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization;
2. Current enrollment in psychological or behavioral health treatment;
3. Current use of psychotropic medications (other than stimulants) prescribed by a physician;
4. Severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility and Acceptability	Before the intervention and 8 weeks later	This measure includes participant (both adolescent and parent/caregiver) attendance, with more attendance of the intervention indicating better feasibility and acceptability.
Adolescent Psychotic-Like Symptom Screener (APSS)	Before the intervention, 8 weeks later, 6 months later, and 12 months later	The APSS is a 7-item measure assessing the presence of: visual and auditory hallucinations, paranoia, grandiosity, delusions of control, mind reading, and delusions of reference. Items are scored on a 3-point Likert scale (0=No, never, 0.5=Maybe, or 1=Yes, definitely) and are then summed for a total score.

Secondary Outcome Measures

Name	Time	Method
The Child Behavior Checklist (CBCL)	Before the intervention, 8 weeks later, 6 months later, and 12 months later	Parents/caregivers rated the CBCL, a 113-item multiple choice self-report measure to capture psychiatric symptoms of the adolescent through parent/caregiver ratings.
The Center for Epidemiological Studies Depression scale for children (CES-DC)	Before the intervention, 8 weeks later, 6 months later, and 12 months later	The CES-DC is a 20-item self-report measure rated on a 4-point Likert scale that captures symptoms of depression within the past week, with higher ratings representing more severe depression.
Concise Health Risk Tracking Self-Report (CHRT-SR)	Before the intervention, 8 weeks later, 6 months later, and 12 months later	The CHRT-SR measures suicidal thoughts and behaviors using 14-items, with higher ratings indicating more suicidal thoughts and behaviors.
Screen for Child Anxiety Related Disorders (SCARED)	Before the intervention, 8 weeks later, 6 months later, and 12 months later	The SCARED is a 41 item measure to capture anxiety. It is rated on a 3 point Likert scale (not true or hardly ever true, somewhat true or sometimes true, or very true or often true).
The Penn Emotion Recognition Test (ER-40)	Before the intervention, 8 weeks later, 6 months later, and 12 months later	This is a 15-minute computer-based task which involves identifying which emotion (neutral, sad, happy, angry, or scared) is being expressed in 40 (half male and half female presenting) online images of faces to measure facial emotion recognition.

Trial Locations

Locations (1)

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