School-Based Living in Families with Emotions Training

January 21, 2025 updated by: Daphne Holt, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Living in Families with Emotions (LIFE)
Behavioral: Living in Families With Emotions
This is an 8-week group-based psychosocial intervention teaching adolescents how to recognize their feelings, manage them, and talk about emotions through group discussions, live exercises, and games. The adolescents' caregivers are also provided with the same information, through two live sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Feasibility and Acceptability
Time Frame: 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.
Before the intervention and 8 weeks later
Adolescent Psychotic-Like Symptom Screener (APSS)
Time Frame: 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.
Before the intervention, 8 weeks later, 6 months later, and 12 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Center for Epidemiological Studies Depression scale for children (CES-DC)
Time Frame: 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.
Before the intervention, 8 weeks later, 6 months later, and 12 months later
Concise Health Risk Tracking Self-Report (CHRT-SR)
Time Frame: 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.
Before the intervention, 8 weeks later, 6 months later, and 12 months later
Screen for Child Anxiety Related Disorders (SCARED)
Time Frame: 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).
Before the intervention, 8 weeks later, 6 months later, and 12 months later
The Child Behavior Checklist (CBCL)
Time Frame: 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.
Before the intervention, 8 weeks later, 6 months later, and 12 months later
The Penn Emotion Recognition Test (ER-40)
Time Frame: 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.
Before the intervention, 8 weeks later, 6 months later, and 12 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2020

Primary Completion (Actual)

January 18, 2024

Study Completion (Actual)

July 20, 2024

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2019P003154

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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