跳至主要内容
临床试验/NCT06793878
NCT06793878已完成不适用

School-Based Living in Families with Emotions Training

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Intervention Feasibility and Acceptability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

Intervention Arm

Experimental

Living in Families with Emotions (LIFE)

干预措施: Living in Families With Emotions (Behavioral)

结局指标

主要结局

Intervention Feasibility and Acceptability

时间窗: 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)

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daphne Holt

Associate Professor

Massachusetts General Hospital

研究点 (1)

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