Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial

针对精神病临床高风险个体的以家庭为中心的治疗：一项验证性疗效试验

• 批准号: 10256074
• 负责人: CARRIE E BEARDEN
• 金额: $ 170.5万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-07 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256074
• 关键词: Achievement; Acute; Adolescence; Adolescent; Adolescent and Young Adult; Aftercare; Age; American; Attenuated; Behavior; Behavioral; Bipolar Disorder; Car Phone; Caring; Case Management; Clinical; Communication; Conflict (Psychology); Deterioration; Development; Diagnostic; Disease remission; Distal; Early Intervention; Education; Emotional; Enrollment; Evidence based intervention; Family; Family Relationship; Family Study; Functional disorder; Individual; Intervention; Interview; Laboratories; Longitudinal Studies; Measurement; Measures; Mediating; Mental disorders; Methodology; Moods; Outcome; Parents; Participant; Patients; Perception; Persons; Population; Problem Solving; Psychoses; Psychotic Disorders; Questionnaires; Randomized; Randomized Clinical Trials; Research; Risk; Sampling; Severities; Site; Social Functioning; Structure; Symptoms; Syndrome; Testing; Time; Training; Validation; Youth; attenuated psychosis syndrome; base; blind; clinical risk; communication behavior; confirmatory clinical trial; confirmatory trial; disorder later incidence prevention; evidence base; experience; follow-up; functional outcomes; high risk; improved; mobile application; offspring; preventive intervention; primary outcome; proband; psychoeducation; psychosocial; psychotic symptoms; randomized trial; recruit; reduce symptoms; remote monitoring; response; secondary outcome; skills; skills training; social; social engagement; symptom management; therapy design; treatment as usual; young adult

Project Summary This proposal responds to RFA-MH-18-707, “Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01).” Adolescents and young adults at clinical high risk (CHR) for psychosis, characterized by recent onset or worsening of attenuated positive symptoms (APS), have a 16%-30% risk of converting to a psychotic disorder in 2 years. In a prior randomized trial in the North American Prodrome Longitudinal Study (NAPLS) network, we showed that family-focused therapy for clinical high-risk persons (FFT- CHR) was more effective than brief family education in (a) improving family (offspring/parent) communication and (b) reducing APS over 6 months, particularly among CHR youth with high baseline scores on a measure of individual risk of psychosis conversion. Both treatments were associated with reductions in young people's perceptions of criticism from parents, which in turn were associated with decreases in APS over 12 months. These findings led us to hypothesize enhanced family communication as a mechanism of action of FFT-CHR. FFT-CHR consists of 18 sessions in 6 months of psychoeducation, communication training, and problem-solving skills training. In the present study conducted in 7 NAPLS sites, we will randomly assign 220 CHR individuals (ages 13-25) and their parent(s) to FFT-CHR or a 6-month Enhanced Care (EC) treatment, consisting of 3 family educational sessions followed by 5 months of individual support and case management. CHR individuals will be interviewed and fill out questionnaires regarding APS (primary outcome) and social functioning (secondary) every 6 months over 18 months. We will examine behavioral targets indicative of improved family relationships: reductions in proportion of critical-conflictual statements and increases in proportion of calm-constructive statements of parents and CHR offspring in laboratory family interactional assessments conducted at baseline and end of treatment (6 months). We will also capture granular changes in targets and outcomes through remote monitoring: CHR participants in both conditions will enroll in a newly developed mobile phone app to facilitate weekly proband ratings of perceived criticism, appraisals of family interactions, and primary and secondary outcomes. We hypothesize that (1) youth/young adults in FFT-CHR will show greater improvements in APS than those in EC in 6 months; (2) improvements in parent and offspring communication by 6 months will be associated with downstream improvements in APS and social functioning over 18 months; and improvements in parent and offspring communication by 6 months will mediate the relationship between treatment condition and changes in primary and secondary outcomes over 18 months. We hypothesize that individuals who are at higher baseline risk of psychosis conversion will show more improvement in targets and primary and secondary outcomes in FFT-CHR than EC, compared to those at lower conversion risk. The involvement of 7 collaborative NAPLS sites with complementary expertise will assure accelerated recruitment of the sample, diagnostic reliability, sample diversity, and treatment exportability.

项目摘要 本提案响应RFA-MH-18-707，“非药理学药物的抗炎疗效临床试验” 精神疾病的干预措施（R 01）。处于精神病临床高风险（HAD）的青少年和年轻人， 特征为近期发作或减弱的阳性症状（APS）恶化，有16%-30%的风险 在两年内转变成精神病在之前的一项随机试验中， 纵向研究（NAPLS）网络，我们表明，以家庭为中心的治疗临床高危人群（FFT- 在（a）改善家庭（子女/父母）沟通方面， 和（B）在6个月内减少APS，特别是在基线得分高的青少年中， 精神病转化的个体风险。这两种治疗方法都与年轻人的 对父母批评的看法，这反过来又与12个月内APS的下降有关。 这些研究结果使我们假设增强家庭沟通作为一种机制的FFT-ESTA的行动。 FFT-BACK包括6个月的心理教育，沟通培训和解决问题的18个课程 技能培训。在7个NAPLS站点进行的本研究中，我们将随机分配220名受试者， (ages 13-25岁）及其父母接受FFT-CHR或6个月的加强护理（EC）治疗，由3个家庭组成 教育课程，然后是5个月的个人支持和个案管理。个人将被 访谈并填写有关APS（主要结局）和社会功能（次要结局）的问卷 每6个月超过18个月。我们将检查表明家庭关系改善的行为目标： 减少批评性-冲突性陈述的比例，增加冷静-建设性陈述的比例 基线时进行的实验室家庭干预评估中父母和子女的陈述 治疗结束（6个月）。我们还将通过远程监控， 监测：两种情况下的受试者都将注册一个新开发的移动的手机应用程序， 每周先证者对感知到的批评、对家庭互动的评价以及主要和次要的 结果。我们假设（1）FFT-OCT中的青年/年轻成人在APS方面的改善大于 6个月时父母和子女沟通的改善将与 18个月内APS和社会功能的下游改善;以及父母和 6个月的后代交流将介导治疗条件与 18个月内的主要和次要结局。我们假设那些处于较高基线的个体 精神病转换的风险将在目标和主要和次要结局方面显示出更多的改善， 与转换风险较低的人相比，FFT-BMPs高于EC。7个NAPLS协作站点的参与 与互补的专业知识将确保加速招募的样本，诊断的可靠性，样本 多样性和治疗出口。