Clinical trial NCT06793878: School-Based Living In Families With Emotions Training
Official title: School-Based Living In Families With Emotions Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Living in Families With Emotions
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Intervention Feasibility and Acceptability
timeFrame: Before the intervention and 8 weeks later
measure: Adolescent Psychotic-Like Symptom Screener (APSS)
timeFrame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Secondary outcomes:
measure: The Center for Epidemiological Studies Depression scale for children (CES-DC)
timeFrame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
measure: Concise Health Risk Tracking Self-Report (CHRT-SR)
timeFrame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
measure: Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
measure: The Child Behavior Checklist (CBCL)
timeFrame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
measure: The Penn Emotion Recognition Test (ER-40)
timeFrame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: