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Completed

NCT Number: NCT06793878

School-Based Living In Families With Emotions Training

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.

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Key information

Conditions

Living in Families With Emotions

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • Current enrollment in psychological or behavioral health treatment;
  • Current use of psychotropic medications (other than stimulants) prescribed by a physician;
  • Severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome).

Treatment and study plan

Living in Families With Emotions

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.